WEBVTT 00:00:00.160 --> 00:00:01.920 Funding for Yale Cancer Answers NOTE Confidence: 0.9338553 00:00:01.920 --> 00:00:03.679 is provided by Smilow Cancer NOTE Confidence: 0.9338553 00:00:03.679 --> 00:00:04.180 Hospital. NOTE Confidence: 0.9436277 00:00:06.080 --> 00:00:08.000 Welcome to Yale Cancer Answers NOTE Confidence: 0.9436277 00:00:08.000 --> 00:00:08.960 with the director of NOTE Confidence: 0.9436277 00:00:08.960 --> 00:00:10.639 Yale Cancer Center, Doctor Eric NOTE Confidence: 0.9436277 00:00:10.639 --> 00:00:11.139 Winer. NOTE Confidence: 0.9857887 00:00:11.679 --> 00:00:13.735 Yale Cancer Answers features conversations NOTE Confidence: 0.9857887 00:00:13.955 --> 00:00:15.875 with oncologists and specialists who NOTE Confidence: 0.9857887 00:00:15.875 --> 00:00:16.755 are on the forefront of NOTE Confidence: 0.9857887 00:00:16.755 --> 00:00:18.055 the battle to fight cancer. NOTE Confidence: 0.91413724 00:00:18.595 --> 00:00:19.895 This week, it's a conversation NOTE Confidence: 0.91413724 00:00:19.954 --> 00:00:21.795 about clinical trials with doctor NOTE Confidence: 0.91413724 00:00:21.795 --> 00:00:23.575 Ian Krop and Alyssa Gateman. NOTE Confidence: 0.9604995 00:00:23.954 --> 00:00:25.314 Doctor Krop is a professor NOTE Confidence: 0.9604995 00:00:25.314 --> 00:00:27.015 of internal medicine and medical NOTE Confidence: 0.9604995 00:00:27.090 --> 00:00:28.450 oncology at the Yale School NOTE Confidence: 0.9604995 00:00:28.450 --> 00:00:30.370 of Medicine, and Alyssa Gateman NOTE Confidence: 0.9604995 00:00:30.370 --> 00:00:31.730 is the executive director of NOTE Confidence: 0.9604995 00:00:31.730 --> 00:00:33.250 the clinical trials office at NOTE Confidence: 0.9604995 00:00:33.250 --> 00:00:35.250 Yale Cancer Center. Here's NOTE Confidence: 0.9604995 00:00:35.250 --> 00:00:36.070 doctor Winer. 00:00:37.650 --> 00:00:39.489 Let's just begin talking NOTE Confidence: 0.99547505 00:00:39.489 --> 00:00:40.610 a little bit about each NOTE Confidence: 0.99547505 00:00:40.610 --> 00:00:42.165 of you and how you NOTE Confidence: 0.99547505 00:00:42.165 --> 00:00:44.325 got interested in this line NOTE Confidence: 0.99547505 00:00:44.325 --> 00:00:45.065 of work. NOTE Confidence: 0.9374024 00:00:45.445 --> 00:00:47.045 Alyssa, how'd you wind NOTE Confidence: 0.9374024 00:00:47.045 --> 00:00:48.905 up working in clinical trials? NOTE Confidence: 0.9977444 00:00:49.445 --> 00:00:50.425 Thank you, Eric. NOTE Confidence: 0.9993561 00:00:51.284 --> 00:00:53.225 I fell into clinical trials NOTE Confidence: 0.9993561 00:00:53.284 --> 00:00:54.985 about twenty five years ago. NOTE Confidence: 0.99866873 00:00:56.190 --> 00:00:57.390 The first part of NOTE Confidence: 0.99866873 00:00:57.390 --> 00:00:58.670 my career, I was working NOTE Confidence: 0.99866873 00:00:58.670 --> 00:00:59.570 with investigators NOTE Confidence: 0.9805025 00:00:59.950 --> 00:01:01.310 on studies that they developed NOTE Confidence: 0.9805025 00:01:01.310 --> 00:01:02.510 themselves and really on the NOTE Confidence: 0.9805025 00:01:02.510 --> 00:01:03.950 data side. But for the NOTE Confidence: 0.9805025 00:01:03.950 --> 00:01:05.470 majority of my career, I NOTE Confidence: 0.9805025 00:01:05.470 --> 00:01:07.650 have been working in quality NOTE Confidence: 0.9759346 00:01:08.535 --> 00:01:11.035 and compliance, really ensuring that NOTE Confidence: 0.9759346 00:01:11.175 --> 00:01:13.575 our patients that NOTE Confidence: 0.9759346 00:01:13.575 --> 00:01:15.275 are participating in research studies NOTE Confidence: 0.9979876 00:01:16.215 --> 00:01:17.035 are protected, NOTE Confidence: 0.97948104 00:01:17.895 --> 00:01:19.495 that they have been provided informed NOTE Confidence: 0.97948104 00:01:19.495 --> 00:01:20.935 consent, and that the data NOTE Confidence: 0.97948104 00:01:20.935 --> 00:01:21.834 that they're providing NOTE Confidence: 0.9149741 00:01:22.535 --> 00:01:23.940 to lead to new treatments NOTE Confidence: 0.9149741 00:01:23.940 --> 00:01:26.200 is actually collected and credible data. NOTE Confidence: 0.98416317 00:01:26.979 --> 00:01:28.180 A few years ago, as NOTE Confidence: 0.98416317 00:01:28.180 --> 00:01:29.560 you know, I transitioned NOTE Confidence: 0.98416317 00:01:29.619 --> 00:01:31.220 now over more to operations NOTE Confidence: 0.98416317 00:01:31.220 --> 00:01:31.959 and administration. 00:01:34.340 --> 00:01:35.540 But one of the passions I NOTE Confidence: 0.9777122 00:01:35.540 --> 00:01:36.920 have is really educating NOTE Confidence: 0.998185 00:01:38.225 --> 00:01:40.385 new clinical research professionals and NOTE Confidence: 0.998185 00:01:40.385 --> 00:01:41.765 making everyone aware NOTE Confidence: 0.9712658 00:01:42.305 --> 00:01:44.065 as they're trying to go NOTE Confidence: 0.9712658 00:01:44.065 --> 00:01:45.505 through their professions and look NOTE Confidence: 0.9712658 00:01:45.505 --> 00:01:46.785 at what their career options NOTE Confidence: 0.9712658 00:01:46.785 --> 00:01:48.385 are of the options of being NOTE Confidence: 0.9712658 00:01:48.385 --> 00:01:49.925 a clinical research professional. NOTE Confidence: 0.9205787 00:01:53.549 --> 00:01:53.950 An Ian, wha NOTE Confidence: 0.99763554 00:01:54.350 --> 00:01:56.049 got you into this? NOTE Confidence: 0.9761274 00:01:56.509 --> 00:01:57.570 You are also NOTE Confidence: 0.961665 00:01:59.070 --> 00:02:01.090 a clinician and a researcher. 00:02:04.110 --> 00:02:05.390 What made you interested in NOTE Confidence: 0.9714222 00:02:05.390 --> 00:02:07.950 cancer, and what got you NOTE Confidence: 0.9714222 00:02:07.950 --> 00:02:09.645 involved in clinical NOTE Confidence: 0.9580774 00:02:10.185 --> 00:02:11.544 trials? NOTE Confidence: 0.9580774 00:02:11.544 --> 00:02:13.705 Personally I didn't fall into clinical trials. NOTE Confidence: 0.9580774 00:02:13.705 --> 00:02:15.005 I think I more gradually NOTE Confidence: 0.9580774 00:02:15.145 --> 00:02:15.645 crawled into this area. 00:02:18.665 --> 00:02:19.405 I was originally NOTE Confidence: 0.81746006 00:02:19.865 --> 00:02:20.445 a laboratory NOTE Confidence: 0.9914715 00:02:20.905 --> 00:02:22.764 researcher trying to understand NOTE Confidence: 0.9962656 00:02:24.150 --> 00:02:26.470 what causes cancer, what causes NOTE Confidence: 0.9962656 00:02:26.470 --> 00:02:28.410 cancer to become resistant NOTE Confidence: 0.87780493 00:02:28.710 --> 00:02:29.610 to our treatments. NOTE Confidence: 0.9804672 00:02:30.950 --> 00:02:32.650 But over time, I NOTE Confidence: 0.986159 00:02:33.510 --> 00:02:35.610 wanted to more directly NOTE Confidence: 0.91597015 00:02:37.575 --> 00:02:40.055 impact patients and have NOTE Confidence: 0.91597015 00:02:40.055 --> 00:02:41.435 the research NOTE Confidence: 0.98882186 00:02:42.375 --> 00:02:44.474 help patients directly rather than NOTE Confidence: 0.98882186 00:02:44.534 --> 00:02:46.394 the gradual process of laboratory NOTE Confidence: 0.98882186 00:02:46.454 --> 00:02:47.915 research. So I started doing NOTE Confidence: 0.98882186 00:02:48.135 --> 00:02:49.034 more and more NOTE Confidence: 0.98496026 00:02:49.540 --> 00:02:51.380 clinical trials, testing new drugs NOTE Confidence: 0.98496026 00:02:51.380 --> 00:02:52.040 to help NOTE Confidence: 0.49567562 00:02:52.419 --> 00:02:52.919 patients NOTE Confidence: 0.85047966 00:02:53.300 --> 00:02:54.840 with breast cancer, and NOTE Confidence: 0.921671 00:02:55.300 --> 00:02:56.280 that just became NOTE Confidence: 0.9031857 00:02:58.340 --> 00:02:59.800 such an exciting field. NOTE Confidence: 0.90097797 00:03:01.220 --> 00:03:02.660 I couldn't leave it until NOTE Confidence: 0.90097797 00:03:02.660 --> 00:03:03.780 it became my full time NOTE Confidence: 0.90097797 00:03:03.780 --> 00:03:05.215 job, roughly twenty NOTE Confidence: 0.90097797 00:03:05.215 --> 00:03:06.255 years ago and have NOTE Confidence: 0.90097797 00:03:06.255 --> 00:03:07.935 continued to do that moving NOTE Confidence: 0.90097797 00:03:07.935 --> 00:03:08.435 from Boston 00:03:09.695 --> 00:03:10.915 now here to Yale, NOTE Confidence: 0.9873828 00:03:11.455 --> 00:03:12.255 two and a half years NOTE Confidence: 0.9873828 00:03:12.255 --> 00:03:12.755 ago. NOTE Confidence: 0.93390566 00:03:13.775 --> 00:03:16.195 Well, clinical trials are obviously NOTE Confidence: 0.93390566 00:03:16.335 --> 00:03:17.100 very important NOTE Confidence: 0.9995887 00:03:17.580 --> 00:03:19.280 because there is no scientific NOTE Confidence: 0.9995887 00:03:19.500 --> 00:03:21.280 discovery that goes from NOTE Confidence: 0.8665339 00:03:21.820 --> 00:03:22.720 some scientist's NOTE Confidence: 0.9990682 00:03:23.100 --> 00:03:23.600 lab NOTE Confidence: 0.9991005 00:03:23.980 --> 00:03:25.760 to the pharmacy NOTE Confidence: 0.9749114 00:03:26.060 --> 00:03:28.220 shelf without a clinical trials NOTE Confidence: 0.9749114 00:03:28.220 --> 00:03:28.720 component NOTE Confidence: 0.99978447 00:03:29.020 --> 00:03:29.680 in between. NOTE Confidence: 0.99913996 00:03:30.405 --> 00:03:31.465 With that said, NOTE Confidence: 0.9528574 00:03:32.325 --> 00:03:34.185 what's involved for a patient NOTE Confidence: 0.9528574 00:03:34.484 --> 00:03:36.344 in joining a clinical trial? NOTE Confidence: 0.9528574 00:03:36.484 --> 00:03:37.605 It's a great question 00:03:39.444 --> 00:03:40.885 because it's not NOTE Confidence: 0.9393154 00:03:40.885 --> 00:03:42.564 something that you necessarily are NOTE Confidence: 0.9393154 00:03:42.564 --> 00:03:44.424 gonna know unless you've NOTE Confidence: 0.9976406 00:03:44.885 --> 00:03:45.625 been involved. NOTE Confidence: 0.99944705 00:03:46.890 --> 00:03:47.849 I don't think many of the 00:03:48.969 --> 00:03:50.730 medicine shows on TV really NOTE Confidence: 0.98359734 00:03:50.730 --> 00:03:51.469 talk about NOTE Confidence: 0.80240375 00:03:51.930 --> 00:03:53.390 clinical trials, so NOTE Confidence: 0.8929451 00:03:54.170 --> 00:03:55.150 happy to explain. NOTE Confidence: 0.9105365 00:03:57.209 --> 00:03:58.430 For most patients, NOTE Confidence: 0.9966083 00:04:00.705 --> 00:04:01.905 getting involved in a clinical NOTE Confidence: 0.9966083 00:04:01.905 --> 00:04:02.885 trial starts NOTE Confidence: 0.99789995 00:04:03.345 --> 00:04:04.645 in their discussions NOTE Confidence: 0.96676046 00:04:05.025 --> 00:04:07.285 with their healthcare provider about NOTE Confidence: 0.98328257 00:04:08.065 --> 00:04:09.585 what treatments makes sense for NOTE Confidence: 0.98328257 00:04:09.585 --> 00:04:10.085 them, NOTE Confidence: 0.97260106 00:04:11.105 --> 00:04:12.305 as in the next step 00:04:14.880 --> 00:04:15.860 of their journey. NOTE Confidence: 0.9938961 00:04:16.640 --> 00:04:17.460 And we NOTE Confidence: 0.96522224 00:04:17.839 --> 00:04:19.760 really feel strongly that a NOTE Confidence: 0.96522224 00:04:19.760 --> 00:04:22.180 clinical trial is part of the 00:04:25.279 --> 00:04:27.600 overall treatment options available to NOTE Confidence: 0.96444315 00:04:27.600 --> 00:04:28.100 patients. NOTE Confidence: 0.8678507 00:04:28.544 --> 00:04:29.764 And so when NOTE Confidence: 0.9143383 00:04:30.305 --> 00:04:31.685 a patient is deciding NOTE Confidence: 0.9288332 00:04:32.145 --> 00:04:33.904 on what treatment option to NOTE Confidence: 0.9288332 00:04:33.904 --> 00:04:34.404 take, NOTE Confidence: 0.803671 00:04:35.425 --> 00:04:36.164 the providers NOTE Confidence: 0.9977292 00:04:36.625 --> 00:04:37.525 provide that NOTE Confidence: 0.9541569 00:04:37.904 --> 00:04:39.585 treatment, a clinical trial option, NOTE Confidence: 0.9541569 00:04:39.585 --> 00:04:40.705 as well as what we NOTE Confidence: 0.9541569 00:04:40.705 --> 00:04:41.985 call standard of care, the NOTE Confidence: 0.9541569 00:04:41.985 --> 00:04:42.964 FDA approved NOTE Confidence: 0.9024917 00:04:43.425 --> 00:04:43.925 options. NOTE Confidence: 0.99843353 00:04:47.960 --> 00:04:49.560 If the trial is of interest NOTE Confidence: 0.99843353 00:04:49.560 --> 00:04:50.380 to the patient, NOTE Confidence: 0.9592752 00:04:51.240 --> 00:04:52.600 we then go into more NOTE Confidence: 0.9592752 00:04:52.600 --> 00:04:53.100 detail about NOTE Confidence: 0.99450916 00:04:53.800 --> 00:04:54.300 about NOTE Confidence: 0.9602803 00:04:54.600 --> 00:04:56.139 what's involved with the trial. 00:04:58.014 --> 00:04:59.055 We go over what's called NOTE Confidence: 0.9500608 00:04:59.055 --> 00:05:00.974 the informed consent document that NOTE Confidence: 0.9500608 00:05:00.974 --> 00:05:02.815 Alyssa mentioned earlier, which is NOTE Confidence: 0.9500608 00:05:02.815 --> 00:05:03.315 basically NOTE Confidence: 0.96490777 00:05:04.735 --> 00:05:06.574 a very in-depth description of NOTE Confidence: 0.96490777 00:05:06.574 --> 00:05:08.514 what's involved in the trial, NOTE Confidence: 0.95575184 00:05:08.895 --> 00:05:11.460 both what procedures and steps NOTE Confidence: 0.95575184 00:05:11.620 --> 00:05:13.300 and visits are required, but NOTE Confidence: 0.95575184 00:05:13.300 --> 00:05:15.139 also most importantly the rationale NOTE Confidence: 0.95575184 00:05:15.139 --> 00:05:16.900 for the and the NOTE Confidence: 0.95575184 00:05:16.900 --> 00:05:18.919 potential benefits and the potential NOTE Confidence: 0.95575184 00:05:18.979 --> 00:05:19.479 risks. 00:05:22.099 --> 00:05:23.880 After the patients read that 00:05:25.964 --> 00:05:27.004 and talk with their family NOTE Confidence: 0.956421 00:05:27.004 --> 00:05:28.125 and talk with their provider, NOTE Confidence: 0.956421 00:05:28.125 --> 00:05:29.504 if they decide they are NOTE Confidence: 0.9571903 00:05:30.284 --> 00:05:31.404 wanting to participate in the NOTE Confidence: 0.9571903 00:05:31.404 --> 00:05:32.525 trial, they would then sign NOTE Confidence: 0.9571903 00:05:32.525 --> 00:05:34.064 the consent. NOTE Confidence: 0.9609086 00:05:34.365 --> 00:05:36.224 Then we would as a team, NOTE Confidence: 0.99457014 00:05:38.080 --> 00:05:39.460 make sure that the patient NOTE Confidence: 0.99457014 00:05:39.760 --> 00:05:41.060 meets what's called the eligibility NOTE Confidence: 0.99457014 00:05:41.360 --> 00:05:42.400 of the trial, which is NOTE Confidence: 0.99457014 00:05:42.400 --> 00:05:43.220 all the NOTE Confidence: 0.98711336 00:05:43.680 --> 00:05:44.180 criteria NOTE Confidence: 0.8576824 00:05:44.640 --> 00:05:45.620 that the patients, NOTE Confidence: 0.8616182 00:05:46.640 --> 00:05:48.720 who the physicians who design NOTE Confidence: 0.8616182 00:05:48.720 --> 00:05:49.380 the trial, NOTE Confidence: 0.9767453 00:05:49.680 --> 00:05:51.220 feel are important from NOTE Confidence: 0.9697919 00:05:52.315 --> 00:05:54.075 both the question that's NOTE Confidence: 0.9697919 00:05:54.075 --> 00:05:55.115 being answered as well as NOTE Confidence: 0.9697919 00:05:55.115 --> 00:05:56.575 the safety for the patients NOTE Confidence: 0.9697919 00:05:56.794 --> 00:05:57.675 that they need to meet NOTE Confidence: 0.9697919 00:05:57.675 --> 00:05:59.675 those criteria to be eligible NOTE Confidence: 0.9697919 00:05:59.675 --> 00:06:01.035 for the trial. If they NOTE Confidence: 0.9697919 00:06:01.035 --> 00:06:02.335 are found to be eligible, NOTE Confidence: 0.9697919 00:06:02.555 --> 00:06:04.095 then they go ahead and NOTE Confidence: 0.9594536 00:06:05.770 --> 00:06:07.230 start the trial NOTE Confidence: 0.9474217 00:06:07.930 --> 00:06:09.530 and continue on the trial NOTE Confidence: 0.9474217 00:06:09.530 --> 00:06:10.830 as part of their NOTE Confidence: 0.9946352 00:06:11.210 --> 00:06:12.590 treatment. So it's not NOTE Confidence: 0.9187726 00:06:14.650 --> 00:06:16.330 oftentimes in addition to their NOTE Confidence: 0.9187726 00:06:16.330 --> 00:06:17.310 treatment, NOTE Confidence: 0.9978033 00:06:18.085 --> 00:06:19.125 that's going to be their NOTE Confidence: 0.9978033 00:06:19.125 --> 00:06:20.245 treatment for the NOTE Confidence: 0.9978033 00:06:20.245 --> 00:06:21.205 period of time that they're NOTE Confidence: 0.9978033 00:06:21.205 --> 00:06:21.944 on the trial. NOTE Confidence: 0.94088525 00:06:22.724 --> 00:06:23.305 Alyssa, maybe NOTE Confidence: 0.9976727 00:06:24.245 --> 00:06:25.845 you can comment on this. NOTE Confidence: 0.99825776 00:06:26.485 --> 00:06:27.944 It seems to me that NOTE Confidence: 0.99973345 00:06:28.324 --> 00:06:29.705 people who have cancer NOTE Confidence: 0.99937814 00:06:30.720 --> 00:06:32.580 are often in a vulnerable NOTE Confidence: 0.99937814 00:06:32.800 --> 00:06:33.300 position. NOTE Confidence: 0.9863518 00:06:33.680 --> 00:06:35.539 They are frightened. NOTE Confidence: 0.9528373 00:06:36.400 --> 00:06:38.979 They sometimes, if newly diagnosed, NOTE Confidence: 0.9528373 00:06:39.199 --> 00:06:40.500 are just overwhelmed NOTE Confidence: 0.8423269 00:06:41.039 --> 00:06:41.779 by information. NOTE Confidence: 0.99069977 00:06:42.904 --> 00:06:44.664 And making a decision about NOTE Confidence: 0.99069977 00:06:44.664 --> 00:06:46.444 participating in a clinical trial NOTE Confidence: 0.95086926 00:06:47.464 --> 00:06:49.245 can be tough, and NOTE Confidence: 0.9993519 00:06:49.625 --> 00:06:51.164 you could also imagine NOTE Confidence: 0.9618727 00:06:51.544 --> 00:06:53.005 that patients at times NOTE Confidence: 0.99970907 00:06:54.920 --> 00:06:57.339 might feel pressured by NOTE Confidence: 0.94818634 00:06:58.279 --> 00:07:00.060 someone, a family member, NOTE Confidence: 0.8870873 00:07:00.920 --> 00:07:02.380 hopefully not a doctor, NOTE Confidence: 0.9472304 00:07:02.839 --> 00:07:04.200 but someone to participate in NOTE Confidence: 0.9472304 00:07:04.200 --> 00:07:05.480 the trial. How do we NOTE Confidence: 0.9472304 00:07:05.480 --> 00:07:07.320 protect people from that sort NOTE Confidence: 0.9472304 00:07:07.320 --> 00:07:07.904 of thing? NOTE Confidence: 0.9936327 00:07:08.865 --> 00:07:10.305 Yeah. So I think, Eric, NOTE Confidence: 0.97779834 00:07:11.185 --> 00:07:12.465 it is, as you said, NOTE Confidence: 0.97779834 00:07:12.465 --> 00:07:13.505 a scary time a lot NOTE Confidence: 0.97779834 00:07:13.505 --> 00:07:14.565 of times NOTE Confidence: 0.9436357 00:07:15.264 --> 00:07:17.365 especially in oncology. NOTE Confidence: 0.99914587 00:07:18.544 --> 00:07:19.845 There's a lot of information NOTE Confidence: 0.99914587 00:07:19.905 --> 00:07:21.605 coming at them. I think NOTE Confidence: 0.9849116 00:07:22.310 --> 00:07:23.350 we wanna make sure that NOTE Confidence: 0.9849116 00:07:23.350 --> 00:07:25.110 our patients feel empowered to NOTE Confidence: 0.9849116 00:07:25.110 --> 00:07:26.390 be able to ask questions NOTE Confidence: 0.9849116 00:07:26.390 --> 00:07:28.010 of both of their providers, NOTE Confidence: 0.9849116 00:07:28.070 --> 00:07:29.350 and, also, we have clinical NOTE Confidence: 0.9849116 00:07:29.350 --> 00:07:31.690 trial office coordinators and nurses NOTE Confidence: 0.9922327 00:07:32.070 --> 00:07:33.450 that are there for additional NOTE Confidence: 0.9922327 00:07:33.510 --> 00:07:34.730 questions and logistics. NOTE Confidence: 0.96900606 00:07:35.350 --> 00:07:36.470 But we also have NOTE Confidence: 0.9944151 00:07:37.794 --> 00:07:39.235 patients whose rights are NOTE Confidence: 0.9944151 00:07:39.235 --> 00:07:41.555 protected. So any clinical research NOTE Confidence: 0.9944151 00:07:41.555 --> 00:07:42.055 trial NOTE Confidence: 0.92878044 00:07:42.675 --> 00:07:44.675 that's ongoing, as Ian had NOTE Confidence: 0.92878044 00:07:44.675 --> 00:07:46.534 mentioned, there's the informed consent. NOTE Confidence: 0.9963853 00:07:47.155 --> 00:07:48.935 That informed consent is reviewed NOTE Confidence: 0.9963853 00:07:48.995 --> 00:07:49.955 by what we call an NOTE Confidence: 0.9963853 00:07:49.955 --> 00:07:51.574 institutional review board NOTE Confidence: 0.99908984 00:07:51.910 --> 00:07:54.170 that reviews things for ethical NOTE Confidence: 0.90119004 00:07:54.550 --> 00:07:55.990 reasons, but then also really NOTE Confidence: 0.90119004 00:07:55.990 --> 00:07:57.030 make sure it NOTE Confidence: 0.9870738 00:07:57.510 --> 00:07:58.170 accurately NOTE Confidence: 0.9399963 00:07:58.950 --> 00:08:00.790 captures the information of that NOTE Confidence: 0.9399963 00:08:00.790 --> 00:08:01.830 trial so they do have NOTE Confidence: 0.9399963 00:08:01.830 --> 00:08:03.450 the information to take home. NOTE Confidence: 0.99406713 00:08:04.310 --> 00:08:05.670 And it's really in the NOTE Confidence: 0.99406713 00:08:05.670 --> 00:08:07.105 patient's rights to have that NOTE Confidence: 0.99406713 00:08:07.105 --> 00:08:08.544 informed consent and all their NOTE Confidence: 0.99406713 00:08:08.544 --> 00:08:09.605 questions answered. NOTE Confidence: 0.917397 00:08:10.305 --> 00:08:11.185 So it should be a NOTE Confidence: 0.917397 00:08:11.185 --> 00:08:12.785 process. It's not a, this NOTE Confidence: 0.917397 00:08:12.785 --> 00:08:13.985 is presented to you and they need a NOTE Confidence: 0.917397 00:08:13.985 --> 00:08:15.025 yes or no right away. NOTE Confidence: 0.9527923 00:08:17.745 --> 00:08:18.785 You can take that back, NOTE Confidence: 0.9527923 00:08:18.785 --> 00:08:19.905 take it to your NOTE Confidence: 0.9527923 00:08:19.905 --> 00:08:21.205 family, friends, trusted NOTE Confidence: 0.94271696 00:08:23.580 --> 00:08:24.620 folks to be able to 00:08:26.220 --> 00:08:27.820 get their questions answered and really NOTE Confidence: 0.94271696 00:08:27.820 --> 00:08:28.560 be thoughtful NOTE Confidence: 0.9996711 00:08:29.020 --> 00:08:30.640 as part of that process. NOTE Confidence: 0.90628725 00:08:31.420 --> 00:08:33.500 Also, after joining in a NOTE Confidence: 0.90628725 00:08:33.500 --> 00:08:35.179 clinical trial, if you agree NOTE Confidence: 0.90628725 00:08:35.179 --> 00:08:35.840 to participate, NOTE Confidence: 0.9678163 00:08:36.455 --> 00:08:37.735 it is in that NOTE Confidence: 0.9678163 00:08:37.735 --> 00:08:40.075 patient rights to withdraw NOTE Confidence: 0.9678163 00:08:40.135 --> 00:08:41.035 at any time, NOTE Confidence: 0.9681556 00:08:41.495 --> 00:08:42.715 and to have that discussion. NOTE Confidence: 0.9681556 00:08:42.855 --> 00:08:44.715 And that won't impact future NOTE Confidence: 0.9681556 00:08:44.775 --> 00:08:45.275 decisions, NOTE Confidence: 0.99286747 00:08:46.615 --> 00:08:48.475 with that ability to withdraw. NOTE Confidence: 0.99616486 00:08:49.015 --> 00:08:50.295 You know, I often tell NOTE Confidence: 0.99616486 00:08:50.295 --> 00:08:50.795 patients NOTE Confidence: 0.9997252 00:08:51.929 --> 00:08:53.389 that the clinical trials NOTE Confidence: 0.9868078 00:08:53.769 --> 00:08:55.449 that we have are not NOTE Confidence: 0.9868078 00:08:55.449 --> 00:08:57.389 clinical trials that some doctor NOTE Confidence: 0.9985709 00:08:57.850 --> 00:08:59.069 or other researcher NOTE Confidence: 0.9584073 00:08:59.850 --> 00:09:01.370 dreamt up some night and NOTE Confidence: 0.9584073 00:09:01.370 --> 00:09:02.649 then put on paper the NOTE Confidence: 0.9584073 00:09:02.649 --> 00:09:04.250 next morning and offered to NOTE Confidence: 0.9584073 00:09:04.250 --> 00:09:06.395 patients the next day, that NOTE Confidence: 0.9978162 00:09:07.735 --> 00:09:08.635 these are NOTE Confidence: 0.99965894 00:09:09.255 --> 00:09:11.115 ideas that have been developed NOTE Confidence: 0.9808057 00:09:11.495 --> 00:09:13.255 and have been reviewed and NOTE Confidence: 0.9808057 00:09:13.255 --> 00:09:15.515 reviewed and reviewed by multiple NOTE Confidence: 0.9808057 00:09:15.575 --> 00:09:16.554 groups of people, NOTE Confidence: 0.9951396 00:09:17.895 --> 00:09:19.815 sometimes on a national level, NOTE Confidence: 0.9951396 00:09:19.815 --> 00:09:20.315 sometimes on a 00:09:21.850 --> 00:09:23.610 local level, but in all NOTE Confidence: 0.98028874 00:09:23.610 --> 00:09:25.470 cases, they are very carefully NOTE Confidence: 0.98028874 00:09:25.610 --> 00:09:26.110 vetted. NOTE Confidence: 0.88264865 00:09:27.210 --> 00:09:28.350 What kind of review NOTE Confidence: 0.99183136 00:09:28.730 --> 00:09:29.230 process NOTE Confidence: 0.9996573 00:09:30.170 --> 00:09:31.070 goes on NOTE Confidence: 0.9996517 00:09:31.929 --> 00:09:32.429 locally NOTE Confidence: 0.99900764 00:09:32.809 --> 00:09:33.850 when we have a NOTE Confidence: 0.99900764 00:09:33.850 --> 00:09:34.830 clinical trial? NOTE Confidence: 0.95065063 00:09:35.635 --> 00:09:36.675 Yeah. So I think NOTE Confidence: 0.95065063 00:09:36.675 --> 00:09:37.554 that's a very NOTE Confidence: 0.95065063 00:09:37.554 --> 00:09:38.274 good point. 00:09:41.235 --> 00:09:42.355 It is quite a NOTE Confidence: 0.97525823 00:09:42.355 --> 00:09:44.515 thorough vetting process. There are NOTE Confidence: 0.97525823 00:09:44.515 --> 00:09:45.654 multiple committees, NOTE Confidence: 0.99908805 00:09:46.274 --> 00:09:46.774 both NOTE Confidence: 0.93576807 00:09:47.154 --> 00:09:48.515 committees made up of the NOTE Confidence: 0.93576807 00:09:48.515 --> 00:09:49.654 experts of NOTE Confidence: 0.9749439 00:09:51.600 --> 00:09:53.440 the cancer type that's NOTE Confidence: 0.9749439 00:09:53.440 --> 00:09:55.120 being evaluated in the clinical NOTE Confidence: 0.9749439 00:09:55.120 --> 00:09:55.620 trial, NOTE Confidence: 0.99973273 00:09:56.720 --> 00:09:57.460 as well NOTE Confidence: 0.95499676 00:09:58.160 --> 00:09:59.679 as experts in a number NOTE Confidence: 0.95499676 00:09:59.679 --> 00:10:00.880 of other fields such as NOTE Confidence: 0.95499676 00:10:00.880 --> 00:10:02.020 statistics and NOTE Confidence: 0.97861034 00:10:04.925 --> 00:10:06.285 logistics of the trial to NOTE Confidence: 0.97861034 00:10:06.285 --> 00:10:07.345 make sure it's feasible. NOTE Confidence: 0.98276967 00:10:08.365 --> 00:10:09.825 And then you have, as NOTE Confidence: 0.9665048 00:10:10.285 --> 00:10:12.684 Alyssa mentioned, the Institutional Review NOTE Confidence: 0.9665048 00:10:12.684 --> 00:10:14.304 Board, which is looking more NOTE Confidence: 0.9665048 00:10:14.445 --> 00:10:15.964 at the ethics of the NOTE Confidence: 0.9665048 00:10:15.964 --> 00:10:17.404 study and making sure patients NOTE Confidence: 0.9665048 00:10:17.404 --> 00:10:18.925 are fully educated about the NOTE Confidence: 0.9665048 00:10:18.925 --> 00:10:19.425 trial. NOTE Confidence: 0.923151 00:10:19.880 --> 00:10:21.580 And that consists of both NOTE Confidence: 0.923151 00:10:21.880 --> 00:10:22.860 medical professionals, NOTE Confidence: 0.760525 00:10:23.480 --> 00:10:24.540 research professionals, NOTE Confidence: 0.9992771 00:10:24.840 --> 00:10:25.660 and community NOTE Confidence: 0.70931333 00:10:26.920 --> 00:10:27.420 representatives to fully 00:10:31.160 --> 00:10:31.980 have the perspective NOTE Confidence: 0.9875342 00:10:32.684 --> 00:10:34.684 of our community involved in NOTE Confidence: 0.9875342 00:10:34.684 --> 00:10:35.965 deciding whether a trial is NOTE Confidence: 0.9875342 00:10:35.965 --> 00:10:37.565 appropriate to move forward. NOTE Confidence: 0.9875342 00:10:37.565 --> 00:10:38.365 And all of those things are NOTE Confidence: 0.9875342 00:10:38.365 --> 00:10:40.285 done both to protect the NOTE Confidence: 0.9875342 00:10:40.285 --> 00:10:41.804 patient, but also to make NOTE Confidence: 0.9875342 00:10:41.804 --> 00:10:42.845 sure that the trial is NOTE Confidence: 0.9875342 00:10:42.845 --> 00:10:43.885 being done in a way NOTE Confidence: 0.9875342 00:10:43.885 --> 00:10:44.385 that's NOTE Confidence: 0.9847637 00:10:45.420 --> 00:10:47.260 optimally designed to be able NOTE Confidence: 0.9847637 00:10:47.260 --> 00:10:48.480 to answer the question NOTE Confidence: 0.93470746 00:10:49.020 --> 00:10:50.380 that's being asked, because NOTE Confidence: 0.93470746 00:10:50.380 --> 00:10:51.740 we're asking patients NOTE Confidence: 0.93470746 00:10:51.740 --> 00:10:52.780 to give up of their NOTE Confidence: 0.93470746 00:10:52.780 --> 00:10:53.280 time NOTE Confidence: 0.87861234 00:10:54.620 --> 00:10:56.000 to participate in the trial. NOTE Confidence: 0.9751266 00:10:56.540 --> 00:10:57.840 Trials are very expensive. NOTE Confidence: 0.93849236 00:10:58.460 --> 00:11:00.195 So there's a lot that NOTE Confidence: 0.93849236 00:11:00.195 --> 00:11:01.315 is involved in the trial. NOTE Confidence: 0.93849236 00:11:01.315 --> 00:11:01.955 And so we at the NOTE Confidence: 0.93849236 00:11:01.955 --> 00:11:02.995 end, we really wanna make NOTE Confidence: 0.93849236 00:11:02.995 --> 00:11:04.215 sure that we're definitively NOTE Confidence: 0.88303894 00:11:04.755 --> 00:11:05.255 answering NOTE Confidence: 0.9864379 00:11:05.715 --> 00:11:07.155 an important question to be NOTE Confidence: 0.9864379 00:11:07.155 --> 00:11:07.895 able to NOTE Confidence: 0.99857545 00:11:08.355 --> 00:11:09.875 help our patients moving forward NOTE Confidence: 0.99857545 00:11:09.875 --> 00:11:11.795 and improve the treatment for NOTE Confidence: 0.99857545 00:11:11.795 --> 00:11:12.390 the next NOTE Confidence: 0.98537755 00:11:13.429 --> 00:11:14.570 generation of patients. NOTE Confidence: 0.97381073 00:11:15.510 --> 00:11:16.010 Now NOTE Confidence: 0.9699914 00:11:16.390 --> 00:11:17.750 we know that there are NOTE Confidence: 0.9699914 00:11:17.750 --> 00:11:19.270 many different kinds of trials, NOTE Confidence: 0.9699914 00:11:19.270 --> 00:11:20.390 and there are trials that NOTE Confidence: 0.9699914 00:11:20.390 --> 00:11:21.450 go from being NOTE Confidence: 0.99845546 00:11:21.910 --> 00:11:23.290 somewhat more investigational NOTE Confidence: 0.99621713 00:11:23.750 --> 00:11:24.970 to somewhat NOTE Confidence: 0.98057985 00:11:26.625 --> 00:11:28.625 more like standard treatment where NOTE Confidence: 0.98057985 00:11:28.625 --> 00:11:30.384 we're just bearing one small NOTE Confidence: 0.98057985 00:11:30.384 --> 00:11:31.745 component to try to see NOTE Confidence: 0.98057985 00:11:31.745 --> 00:11:33.264 if we can make a NOTE Confidence: 0.98057985 00:11:33.264 --> 00:11:35.524 treatment a little less toxic NOTE Confidence: 0.98057985 00:11:35.665 --> 00:11:36.945 or a little bit more NOTE Confidence: 0.98057985 00:11:36.945 --> 00:11:37.445 effective. NOTE Confidence: 0.9900139 00:11:38.370 --> 00:11:39.570 So we often refer to NOTE Confidence: 0.9900139 00:11:39.570 --> 00:11:40.929 these as phase one and NOTE Confidence: 0.9900139 00:11:40.929 --> 00:11:42.290 phase two and phase three NOTE Confidence: 0.9900139 00:11:42.290 --> 00:11:42.790 trials. NOTE Confidence: 0.9996282 00:11:43.170 --> 00:11:44.130 Could you tell us a NOTE Confidence: 0.9996282 00:11:44.130 --> 00:11:45.110 little bit about NOTE Confidence: 0.99962175 00:11:45.490 --> 00:11:46.630 what each of those NOTE Confidence: 0.93595594 00:11:47.890 --> 00:11:49.970 consists of? NOTE Confidence: 0.93595594 00:11:49.970 --> 00:11:50.690 In a very NOTE Confidence: 0.93595594 00:11:50.690 --> 00:11:51.590 concise way, NOTE Confidence: 0.9680412 00:11:52.554 --> 00:11:53.995 the first trial NOTE Confidence: 0.9680412 00:11:53.995 --> 00:11:55.515 is a phase one trial NOTE Confidence: 0.9680412 00:11:55.515 --> 00:11:57.595 where we're initially looking at NOTE Confidence: 0.9680412 00:11:57.595 --> 00:11:58.475 a drug for the first NOTE Confidence: 0.9680412 00:11:58.475 --> 00:12:00.095 time in patients and that's NOTE Confidence: 0.9680412 00:12:00.235 --> 00:12:01.675 purely just making sure that NOTE Confidence: 0.9680412 00:12:01.675 --> 00:12:02.635 it's safe to give the NOTE Confidence: 0.9680412 00:12:02.635 --> 00:12:04.050 drug and that we figure NOTE Confidence: 0.9680412 00:12:04.050 --> 00:12:05.090 out what the right dose is. 00:12:06.050 --> 00:12:07.410 That's a small trial with NOTE Confidence: 0.9680412 00:12:07.410 --> 00:12:09.170 generally maybe only twenty or NOTE Confidence: 0.9680412 00:12:09.170 --> 00:12:09.990 thirty patients. NOTE Confidence: 0.95550406 00:12:11.010 --> 00:12:12.130 And if I can NOTE Confidence: 0.95550406 00:12:12.130 --> 00:12:13.330 just interrupt and to be NOTE Confidence: 0.95550406 00:12:13.330 --> 00:12:14.929 clear, that's the endpoint of NOTE Confidence: 0.95550406 00:12:14.929 --> 00:12:16.290 the trial, although when a NOTE Confidence: 0.95550406 00:12:16.290 --> 00:12:17.970 doctor is treating a patient, NOTE Confidence: 0.95550406 00:12:17.970 --> 00:12:19.170 it's with the hope that NOTE Confidence: 0.95550406 00:12:19.170 --> 00:12:20.605 that drug will help someone. NOTE Confidence: 0.97756857 00:12:20.985 --> 00:12:22.504 That is correct. NOTE Confidence: 0.97756857 00:12:22.504 --> 00:12:23.785 And that is also looked NOTE Confidence: 0.97756857 00:12:23.785 --> 00:12:24.824 at in the trial. But NOTE Confidence: 0.97756857 00:12:24.824 --> 00:12:26.264 as you said, the NOTE Confidence: 0.97756857 00:12:26.264 --> 00:12:28.264 primary purpose is to just NOTE Confidence: 0.97756857 00:12:28.264 --> 00:12:29.545 establish the safety and the NOTE Confidence: 0.97756857 00:12:29.545 --> 00:12:30.285 right dose. NOTE Confidence: 0.97939473 00:12:30.665 --> 00:12:32.125 Nowadays, because our NOTE Confidence: 0.9994972 00:12:32.459 --> 00:12:33.439 drugs are so NOTE Confidence: 0.9739999 00:12:34.059 --> 00:12:35.420 sophisticated, as soon as they NOTE Confidence: 0.9739999 00:12:35.420 --> 00:12:36.459 come out of the lab, NOTE Confidence: 0.9739999 00:12:36.459 --> 00:12:38.139 oftentimes, we actually see, you NOTE Confidence: 0.9739999 00:12:38.139 --> 00:12:39.179 know, a great deal of NOTE Confidence: 0.9739999 00:12:39.579 --> 00:12:41.179 effectiveness in that even in NOTE Confidence: 0.9739999 00:12:41.179 --> 00:12:42.079 that first trial. NOTE Confidence: 0.9379518 00:12:43.259 --> 00:12:44.459 And in a phase two NOTE Confidence: 0.9379518 00:12:44.459 --> 00:12:44.959 trial? NOTE Confidence: 0.98543406 00:12:46.095 --> 00:12:47.215 So a phase two trial NOTE Confidence: 0.98543406 00:12:47.215 --> 00:12:48.575 is a slightly larger trial NOTE Confidence: 0.98543406 00:12:48.575 --> 00:12:49.855 where we're now really trying NOTE Confidence: 0.98543406 00:12:49.855 --> 00:12:51.535 to focus on how effective NOTE Confidence: 0.98543406 00:12:51.535 --> 00:12:52.675 that drug is, NOTE Confidence: 0.93772733 00:12:53.295 --> 00:12:55.315 for that particular patient population. NOTE Confidence: 0.97796357 00:12:55.855 --> 00:12:57.455 And then if it shows NOTE Confidence: 0.97796357 00:12:57.455 --> 00:12:58.110 to be NOTE Confidence: 0.99959046 00:12:58.589 --> 00:12:59.089 effective NOTE Confidence: 0.941303 00:12:59.550 --> 00:13:00.910 and promising, it then moves NOTE Confidence: 0.941303 00:13:00.910 --> 00:13:02.110 to a phase three trial NOTE Confidence: 0.941303 00:13:02.110 --> 00:13:03.950 where that trial drug is NOTE Confidence: 0.941303 00:13:03.950 --> 00:13:04.769 being compared NOTE Confidence: 0.9952408 00:13:05.470 --> 00:13:06.750 to the current standard of NOTE Confidence: 0.9952408 00:13:06.750 --> 00:13:07.950 care to see which one NOTE Confidence: 0.9952408 00:13:07.950 --> 00:13:09.730 actually is more effective. NOTE Confidence: 0.99707586 00:13:10.829 --> 00:13:12.610 Well, that is very helpful. NOTE Confidence: 0.98564875 00:13:13.505 --> 00:13:15.105 We're gonna just take a NOTE Confidence: 0.98564875 00:13:15.105 --> 00:13:16.625 very brief break, and we'll NOTE Confidence: 0.98564875 00:13:16.625 --> 00:13:18.165 be back with our guests NOTE Confidence: 0.80775195 00:13:19.105 --> 00:13:21.125 Alyssa Gateman and Ian Krop NOTE Confidence: 0.80775195 00:13:21.184 --> 00:13:22.725 in just a minute. NOTE Confidence: 0.9568745 00:13:23.184 --> 00:13:24.865 Funding for Yale Cancer Answers NOTE Confidence: 0.9568745 00:13:24.865 --> 00:13:26.804 comes from Smilow Cancer Hospital, NOTE Confidence: 0.9748314 00:13:27.200 --> 00:13:28.800 where the Lung Cancer Screening NOTE Confidence: 0.9748314 00:13:28.800 --> 00:13:30.480 Program provides screening to those NOTE Confidence: 0.9748314 00:13:30.480 --> 00:13:31.940 at risk for lung cancer NOTE Confidence: 0.9748314 00:13:32.080 --> 00:13:32.980 and individualized NOTE Confidence: 0.96851003 00:13:33.440 --> 00:13:34.660 state of the art evaluation NOTE Confidence: 0.96851003 00:13:34.800 --> 00:13:35.860 of lung nodules. NOTE Confidence: 0.9715599 00:13:36.320 --> 00:13:38.020 To learn more, visit smilowcancerhospital NOTE Confidence: 0.9954567 00:13:38.960 --> 00:13:39.779 dot org. NOTE Confidence: 0.9800803 00:13:41.485 --> 00:13:42.765 Over two hundred and thirty NOTE Confidence: 0.9800803 00:13:42.765 --> 00:13:44.625 thousand Americans will be diagnosed NOTE Confidence: 0.9800803 00:13:44.684 --> 00:13:46.445 with lung cancer this year, NOTE Confidence: 0.9800803 00:13:46.445 --> 00:13:47.965 and in Connecticut alone, there NOTE Confidence: 0.9800803 00:13:47.965 --> 00:13:49.245 will be over twenty seven NOTE Confidence: 0.9800803 00:13:49.245 --> 00:13:50.385 hundred new cases. NOTE Confidence: 0.9751513 00:13:50.845 --> 00:13:52.125 More than eighty five percent NOTE Confidence: 0.9751513 00:13:52.125 --> 00:13:54.045 of lung cancer diagnoses are NOTE Confidence: 0.9751513 00:13:54.045 --> 00:13:55.184 related to smoking, NOTE Confidence: 0.9844599 00:13:55.629 --> 00:13:57.470 and quitting, even after decades NOTE Confidence: 0.9844599 00:13:57.470 --> 00:13:59.389 of use can significantly reduce NOTE Confidence: 0.9844599 00:13:59.389 --> 00:14:00.910 your risk of developing lung NOTE Confidence: 0.9844599 00:14:00.910 --> 00:14:01.410 cancer. NOTE Confidence: 0.966442 00:14:01.949 --> 00:14:03.389 Each day, patients with lung NOTE Confidence: 0.966442 00:14:03.389 --> 00:14:05.309 cancer are surviving thanks to NOTE Confidence: 0.966442 00:14:05.309 --> 00:14:07.230 increased access to advanced therapies NOTE Confidence: 0.966442 00:14:07.230 --> 00:14:08.689 and specialized care. NOTE Confidence: 0.9969157 00:14:09.065 --> 00:14:10.745 New treatment options and surgical NOTE Confidence: 0.9969157 00:14:10.745 --> 00:14:12.345 techniques are giving lung cancer NOTE Confidence: 0.9969157 00:14:12.345 --> 00:14:13.625 survivors more hope than they NOTE Confidence: 0.9969157 00:14:13.625 --> 00:14:14.765 have ever had before. NOTE Confidence: 0.9818846 00:14:15.385 --> 00:14:17.225 Clinical trials are currently underway NOTE Confidence: 0.9818846 00:14:17.225 --> 00:14:19.865 at federally designated comprehensive cancer NOTE Confidence: 0.9818846 00:14:19.865 --> 00:14:20.365 centers NOTE Confidence: 0.8968569 00:14:20.760 --> 00:14:22.120 such as the battle two NOTE Confidence: 0.8968569 00:14:22.120 --> 00:14:23.640 trial at Yale Cancer Center NOTE Confidence: 0.8968569 00:14:23.640 --> 00:14:25.260 and Smilow Cancer Hospital, NOTE Confidence: 0.9912487 00:14:25.800 --> 00:14:26.840 to learn if a drug NOTE Confidence: 0.9912487 00:14:26.840 --> 00:14:28.600 or combination of drugs based NOTE Confidence: 0.9912487 00:14:28.600 --> 00:14:29.900 on personal biomarkers NOTE Confidence: 0.9938679 00:14:30.280 --> 00:14:31.720 can help to control non NOTE Confidence: 0.9938679 00:14:31.720 --> 00:14:33.180 small cell lung cancer. NOTE Confidence: 0.98914665 00:14:33.665 --> 00:14:35.345 More information is available at NOTE Confidence: 0.98914665 00:14:35.345 --> 00:14:37.125 yale cancer center dot org. NOTE Confidence: 0.98914665 00:14:37.345 --> 00:14:39.024 You're listening to Connecticut Public NOTE Confidence: 0.98914665 00:14:39.024 --> 00:14:39.524 Radio. NOTE Confidence: 0.95389307 00:14:40.464 --> 00:14:42.064 Good evening again. This is NOTE Confidence: 0.95389307 00:14:42.064 --> 00:14:43.985 Eric Winer. I'm the director NOTE Confidence: 0.95389307 00:14:43.985 --> 00:14:45.764 of Yale Cancer Center, NOTE Confidence: 0.95389307 00:14:45.904 --> 00:14:48.630 and I'm here tonight on NOTE Confidence: 0.95389307 00:14:48.790 --> 00:14:50.470 Yale Cancer Answers with my NOTE Confidence: 0.95389307 00:14:50.470 --> 00:14:50.970 guests NOTE Confidence: 0.6716644 00:14:51.350 --> 00:14:52.810 doctor Ian Krop NOTE Confidence: 0.9574543 00:14:53.830 --> 00:14:55.350 who is the director of NOTE Confidence: 0.9574543 00:14:55.350 --> 00:14:56.710 the clinical trials office, and NOTE Confidence: 0.9574543 00:14:56.710 --> 00:14:58.550 Alyssa Gateman, the executive director NOTE Confidence: 0.9574543 00:14:58.550 --> 00:15:00.250 of the clinical trials office. NOTE Confidence: 0.9547268 00:15:02.175 --> 00:15:03.455 Alyssa, maybe I can start NOTE Confidence: 0.9547268 00:15:03.455 --> 00:15:04.195 with you. NOTE Confidence: 0.91524994 00:15:06.735 --> 00:15:08.115 Why is it important NOTE Confidence: 0.99986494 00:15:09.375 --> 00:15:09.875 that NOTE Confidence: 0.99855673 00:15:10.495 --> 00:15:12.255 we include a diverse group NOTE Confidence: 0.99855673 00:15:12.255 --> 00:15:14.115 of people in clinical trials? NOTE Confidence: 0.99855673 00:15:14.255 --> 00:15:15.375 I think there's been a NOTE Confidence: 0.99855673 00:15:15.375 --> 00:15:16.995 tendency in years past NOTE Confidence: 0.98766166 00:15:17.600 --> 00:15:19.520 for our clinical trials population NOTE Confidence: 0.98766166 00:15:19.520 --> 00:15:20.980 to look a little homogeneous, NOTE Confidence: 0.98411775 00:15:21.440 --> 00:15:23.040 and we're all worried about NOTE Confidence: 0.98411775 00:15:23.040 --> 00:15:24.320 that. And we wanna make NOTE Confidence: 0.98411775 00:15:24.320 --> 00:15:26.720 sure that that's something that NOTE Confidence: 0.98411775 00:15:26.720 --> 00:15:28.020 that doesn't continue. 00:15:30.715 --> 00:15:31.535 So diversity NOTE Confidence: 0.99895394 00:15:31.915 --> 00:15:33.435 and inclusion in our clinical NOTE Confidence: 0.99895394 00:15:33.435 --> 00:15:35.595 trials is extremely important. At NOTE Confidence: 0.99895394 00:15:35.595 --> 00:15:36.575 the end of the day, NOTE Confidence: 0.99895394 00:15:36.715 --> 00:15:38.015 our clinical research NOTE Confidence: 0.997103 00:15:39.115 --> 00:15:40.475 is putting new products and NOTE Confidence: 0.997103 00:15:40.475 --> 00:15:42.715 new treatments out for the NOTE Confidence: 0.997103 00:15:42.715 --> 00:15:44.395 population. So what we're really NOTE Confidence: 0.997103 00:15:44.395 --> 00:15:45.615 looking for is NOTE Confidence: 0.99919826 00:15:46.050 --> 00:15:46.550 generalizability NOTE Confidence: 0.99962026 00:15:47.010 --> 00:15:48.310 of research results. NOTE Confidence: 0.9991372 00:15:48.850 --> 00:15:49.990 If we have a homogeneous NOTE Confidence: 0.99948287 00:15:50.529 --> 00:15:51.029 population, NOTE Confidence: 0.9888104 00:15:51.730 --> 00:15:53.170 we only really get answers NOTE Confidence: 0.9888104 00:15:53.170 --> 00:15:54.930 on that population on how NOTE Confidence: 0.9888104 00:15:54.930 --> 00:15:56.130 it works. And there are NOTE Confidence: 0.9888104 00:15:56.130 --> 00:15:58.310 differences. There's differences between genders. NOTE Confidence: 0.9986214 00:15:58.775 --> 00:16:00.695 There's differences between ages. There's NOTE Confidence: 0.9986214 00:16:00.695 --> 00:16:02.855 differences between racial and ethnic NOTE Confidence: 0.9986214 00:16:02.855 --> 00:16:03.355 groups. NOTE Confidence: 0.9879118 00:16:03.735 --> 00:16:06.135 So ensuring that the entire NOTE Confidence: 0.9879118 00:16:06.135 --> 00:16:07.735 population that's going to be NOTE Confidence: 0.9879118 00:16:07.735 --> 00:16:09.515 treated with that product potentially NOTE Confidence: 0.987437 00:16:10.215 --> 00:16:11.895 is included in those research NOTE Confidence: 0.987437 00:16:11.895 --> 00:16:12.395 studies, NOTE Confidence: 0.9970601 00:16:13.220 --> 00:16:14.660 is really important so that NOTE Confidence: 0.9970601 00:16:14.660 --> 00:16:16.100 we can understand all the NOTE Confidence: 0.9970601 00:16:16.100 --> 00:16:18.259 different potential side effects and NOTE Confidence: 0.9970601 00:16:18.259 --> 00:16:20.100 the different effectiveness NOTE Confidence: 0.9970601 00:16:20.100 --> 00:16:21.720 for those patients that ultimately NOTE Confidence: 0.9970601 00:16:21.860 --> 00:16:23.399 may be receiving those therapies. NOTE Confidence: 0.99935955 00:16:24.500 --> 00:16:25.000 And NOTE Confidence: 0.9941098 00:16:25.625 --> 00:16:27.464 we and others have pushed NOTE Confidence: 0.9941098 00:16:27.464 --> 00:16:28.925 very hard to NOTE Confidence: 0.9997336 00:16:29.385 --> 00:16:30.605 make sure that NOTE Confidence: 0.9844002 00:16:30.985 --> 00:16:33.065 our clinical trials do include NOTE Confidence: 0.9844002 00:16:33.065 --> 00:16:34.585 a diverse group of patients. NOTE Confidence: 0.9844002 00:16:34.585 --> 00:16:36.265 And, of course, there have been 00:16:37.145 --> 00:16:39.245 research findings over the past NOTE Confidence: 0.99946713 00:16:39.430 --> 00:16:41.110 couple of decades that have NOTE Confidence: 0.99946713 00:16:41.110 --> 00:16:42.010 shown that NOTE Confidence: 0.98827463 00:16:42.470 --> 00:16:44.390 many people who are from NOTE Confidence: 0.98827463 00:16:44.390 --> 00:16:46.470 underrepresented backgrounds just don't get NOTE Confidence: 0.98827463 00:16:46.470 --> 00:16:48.310 offered clinical trials as often NOTE Confidence: 0.98827463 00:16:48.310 --> 00:16:49.670 as others, and so NOTE Confidence: 0.98827463 00:16:49.670 --> 00:16:51.270 we really try to do NOTE Confidence: 0.98827463 00:16:51.270 --> 00:16:52.710 that as do people around NOTE Confidence: 0.98827463 00:16:52.710 --> 00:16:53.370 the country. NOTE Confidence: 0.99483067 00:16:54.605 --> 00:16:55.885 I wanna move on to NOTE Confidence: 0.99483067 00:16:55.885 --> 00:16:57.265 talk for a minute about NOTE Confidence: 0.99483067 00:16:57.405 --> 00:16:59.185 myths about clinical trials. 00:17:02.765 --> 00:17:03.265 Ian, NOTE Confidence: 0.9970736 00:17:03.885 --> 00:17:05.585 I'm sure you've had patients NOTE Confidence: 0.9970736 00:17:05.805 --> 00:17:07.244 say to you over the NOTE Confidence: 0.9970736 00:17:07.244 --> 00:17:07.744 years, NOTE Confidence: 0.89651275 00:17:08.859 --> 00:17:09.919 doctor Krop, NOTE Confidence: 0.9949833 00:17:10.380 --> 00:17:11.679 don't you just wanna NOTE Confidence: 0.9856518 00:17:11.980 --> 00:17:13.740 use me as a guinea NOTE Confidence: 0.9856518 00:17:13.740 --> 00:17:14.240 pig? NOTE Confidence: 0.9973546 00:17:14.859 --> 00:17:15.359 And NOTE Confidence: 0.99549836 00:17:16.460 --> 00:17:17.580 how do you answer that NOTE Confidence: 0.99549836 00:17:17.580 --> 00:17:18.080 question? 00:17:22.115 --> 00:17:23.335 I think that's an important NOTE Confidence: 0.95179313 00:17:23.635 --> 00:17:25.255 point to clarify NOTE Confidence: 0.95179313 00:17:25.395 --> 00:17:26.515 because there is that myth NOTE Confidence: 0.95179313 00:17:26.515 --> 00:17:27.255 out there. NOTE Confidence: 0.9585145 00:17:28.035 --> 00:17:29.715 And I think as Alyssa very 00:17:35.010 --> 00:17:37.330 eloquently stated, how important it is for NOTE Confidence: 0.8655472 00:17:41.890 --> 00:17:43.250 anybody on a trial NOTE Confidence: 0.8655472 00:17:43.250 --> 00:17:44.630 that their rights are protected NOTE Confidence: 0.8655472 00:17:44.770 --> 00:17:46.455 and that the safety NOTE Confidence: 0.94272494 00:17:47.015 --> 00:17:48.635 of them is paramount NOTE Confidence: 0.94272494 00:17:48.695 --> 00:17:50.375 and an enormous amount NOTE Confidence: 0.94272494 00:17:50.375 --> 00:17:51.894 of work goes into making NOTE Confidence: 0.94272494 00:17:51.894 --> 00:17:53.174 sure that is actually NOTE Confidence: 0.94272494 00:17:53.174 --> 00:17:53.835 the case. NOTE Confidence: 0.9188552 00:17:55.095 --> 00:17:56.154 But, you know, NOTE Confidence: 0.90994895 00:17:56.534 --> 00:17:57.414 again, I think a NOTE Confidence: 0.90994895 00:17:57.414 --> 00:17:58.394 clinical trial, NOTE Confidence: 0.8469146 00:17:59.609 --> 00:18:00.109 particularly NOTE Confidence: 0.9872157 00:18:02.250 --> 00:18:03.470 in this day and age, NOTE Confidence: 0.94671667 00:18:04.490 --> 00:18:06.270 is the way to get NOTE Confidence: 0.9661524 00:18:07.050 --> 00:18:08.570 access to the NOTE Confidence: 0.9661524 00:18:08.570 --> 00:18:10.030 most cutting edge treatments, 00:18:13.450 --> 00:18:14.109 and I think NOTE Confidence: 0.98514795 00:18:14.425 --> 00:18:15.965 those of us NOTE Confidence: 0.9793781 00:18:16.505 --> 00:18:17.785 at Yale Cancer Center NOTE Confidence: 0.9793781 00:18:17.785 --> 00:18:19.385 feel that a clinical trial NOTE Confidence: 0.9793781 00:18:19.385 --> 00:18:21.085 is really part of 00:18:23.785 --> 00:18:25.885 top quality NOTE Confidence: 0.9701948 00:18:26.744 --> 00:18:28.045 cancer care now, NOTE Confidence: 0.9723955 00:18:29.010 --> 00:18:30.609 having access to clinical trials NOTE Confidence: 0.9723955 00:18:30.609 --> 00:18:31.430 is really NOTE Confidence: 0.8201409 00:18:31.970 --> 00:18:32.470 critical, NOTE Confidence: 0.98120844 00:18:33.890 --> 00:18:34.630 for that. 00:18:36.450 --> 00:18:37.330 And getting back to NOTE Confidence: 0.98812723 00:18:37.330 --> 00:18:38.690 your previous question about the NOTE Confidence: 0.98812723 00:18:38.690 --> 00:18:39.890 need to make sure that NOTE Confidence: 0.98812723 00:18:39.890 --> 00:18:41.270 we have a diverse population, NOTE Confidence: 0.97982585 00:18:41.570 --> 00:18:42.645 I think not only do NOTE Confidence: 0.97982585 00:18:42.645 --> 00:18:43.685 we need a diverse population NOTE Confidence: 0.97982585 00:18:43.685 --> 00:18:44.805 in our clinical trials so NOTE Confidence: 0.97982585 00:18:44.805 --> 00:18:45.845 that we can make sure NOTE Confidence: 0.97982585 00:18:45.845 --> 00:18:47.285 that the results we get NOTE Confidence: 0.97982585 00:18:47.285 --> 00:18:49.625 are applicable to all groups, NOTE Confidence: 0.9993297 00:18:50.405 --> 00:18:51.705 I think it's also NOTE Confidence: 0.9572502 00:18:52.405 --> 00:18:54.085 a disparities issue. I think NOTE Confidence: 0.9572502 00:18:54.085 --> 00:18:55.525 if people don't have NOTE Confidence: 0.9572502 00:18:55.525 --> 00:18:56.505 access to NOTE Confidence: 0.9898226 00:18:56.830 --> 00:18:57.810 clinical trials, NOTE Confidence: 0.9932828 00:18:58.590 --> 00:18:59.890 where they're being seen, NOTE Confidence: 0.99952394 00:19:00.350 --> 00:19:01.890 they don't have access to NOTE Confidence: 0.87884665 00:19:02.910 --> 00:19:04.350 to the optimal care. NOTE Confidence: 0.87884665 00:19:04.350 --> 00:19:05.550 And I think that's NOTE Confidence: 0.87884665 00:19:05.550 --> 00:19:06.910 another reason why NOTE Confidence: 0.986191 00:19:07.310 --> 00:19:08.510 at Yale Cancer Center we try to 00:19:09.150 --> 00:19:10.270 make sure we have access NOTE Confidence: 0.986191 00:19:10.270 --> 00:19:11.390 to clinical trials for our NOTE Confidence: 0.986191 00:19:11.390 --> 00:19:12.925 patients across all NOTE Confidence: 0.986191 00:19:12.925 --> 00:19:14.525 of our sites NOTE Confidence: 0.986191 00:19:14.525 --> 00:19:15.425 across Connecticut. NOTE Confidence: 0.9642289 00:19:16.445 --> 00:19:18.865 And while there are obviously NOTE Confidence: 0.9642289 00:19:18.925 --> 00:19:19.744 no guarantees NOTE Confidence: 0.98820686 00:19:20.045 --> 00:19:21.805 when someone receives a standard NOTE Confidence: 0.98820686 00:19:21.805 --> 00:19:22.865 treatment or NOTE Confidence: 0.9567893 00:19:23.244 --> 00:19:24.465 when they're on a clinical NOTE Confidence: 0.9567893 00:19:24.525 --> 00:19:25.025 trial, the 00:19:26.685 --> 00:19:27.905 hope when people NOTE Confidence: 0.9973848 00:19:28.420 --> 00:19:30.180 develop clinical trials is that NOTE Confidence: 0.9973848 00:19:30.180 --> 00:19:31.859 the treatment is actually going NOTE Confidence: 0.9973848 00:19:31.859 --> 00:19:33.140 to be better in one NOTE Confidence: 0.9973848 00:19:33.140 --> 00:19:34.040 way or another. NOTE Confidence: 0.9993789 00:19:34.580 --> 00:19:36.520 We don't go into clinical NOTE Confidence: 0.9993789 00:19:36.580 --> 00:19:37.080 trials NOTE Confidence: 0.96400315 00:19:37.780 --> 00:19:38.280 intending NOTE Confidence: 0.9873894 00:19:38.740 --> 00:19:40.020 to come up with a NOTE Confidence: 0.9873894 00:19:40.020 --> 00:19:42.115 worse result, and it doesn't NOTE Confidence: 0.9873894 00:19:42.115 --> 00:19:42.615 happen NOTE Confidence: 0.97819155 00:19:42.915 --> 00:19:45.315 very often. Although, again, there NOTE Confidence: 0.97819155 00:19:45.315 --> 00:19:47.575 can be no guarantees. NOTE Confidence: 0.99867314 00:19:49.955 --> 00:19:51.315 Can you give us some NOTE Confidence: 0.99867314 00:19:51.315 --> 00:19:51.815 examples NOTE Confidence: 0.9866709 00:19:52.915 --> 00:19:54.695 of some of the breakthroughs NOTE Confidence: 0.9866709 00:19:54.835 --> 00:19:56.250 we've seen in the last NOTE Confidence: 0.9866709 00:19:56.330 --> 00:19:57.550 five to ten years, NOTE Confidence: 0.85240024 00:19:58.090 --> 00:19:58.590 and, NOTE Confidence: 0.9996465 00:19:59.930 --> 00:20:00.910 there are many NOTE Confidence: 0.98959285 00:20:01.369 --> 00:20:02.650 that have come about as NOTE Confidence: 0.98959285 00:20:02.650 --> 00:20:04.190 a result of clinical trials. NOTE Confidence: 0.9648676 00:20:06.090 --> 00:20:06.890 Yeah. I would NOTE Confidence: 0.9648676 00:20:06.890 --> 00:20:08.730 argue that essentially all of NOTE Confidence: 0.9648676 00:20:08.730 --> 00:20:10.490 the breakthroughs that have happened NOTE Confidence: 0.9648676 00:20:10.490 --> 00:20:11.535 in the last five or NOTE Confidence: 0.9648676 00:20:11.615 --> 00:20:12.435 ten years NOTE Confidence: 0.97531337 00:20:13.775 --> 00:20:15.055 are as a result of NOTE Confidence: 0.97531337 00:20:15.055 --> 00:20:16.575 clinical trials. As you said NOTE Confidence: 0.97531337 00:20:16.575 --> 00:20:18.335 in the introduction, a 00:20:19.455 --> 00:20:20.734 drug doesn't go from the NOTE Confidence: 0.9993417 00:20:20.734 --> 00:20:21.234 laboratory NOTE Confidence: 0.92389125 00:20:21.535 --> 00:20:22.595 to the pharmacy. NOTE Confidence: 0.99900275 00:20:23.295 --> 00:20:24.835 It only gets to NOTE Confidence: 0.9974779 00:20:25.369 --> 00:20:26.810 a place where patients can NOTE Confidence: 0.9974779 00:20:26.810 --> 00:20:28.430 access it through clinical trials. NOTE Confidence: 0.8011331 00:20:29.530 --> 00:20:30.030 And, NOTE Confidence: 0.99062717 00:20:30.570 --> 00:20:31.230 you know, NOTE Confidence: 0.92045903 00:20:32.650 --> 00:20:33.850 twenty years ago when I NOTE Confidence: 0.92045903 00:20:33.850 --> 00:20:35.450 started in this field, or NOTE Confidence: 0.92045903 00:20:35.450 --> 00:20:37.050 actually, now it's twenty five NOTE Confidence: 0.92045903 00:20:37.050 --> 00:20:37.790 years ago, NOTE Confidence: 0.9658357 00:20:38.330 --> 00:20:39.070 time flies, NOTE Confidence: 0.982862 00:20:39.530 --> 00:20:40.830 you know, we were NOTE Confidence: 0.89103204 00:20:41.984 --> 00:20:43.605 in breast cancer, for example, NOTE Confidence: 0.88428974 00:20:43.984 --> 00:20:45.285 in almost all cancers, NOTE Confidence: 0.95960337 00:20:46.385 --> 00:20:48.145 the treatments available were essentially NOTE Confidence: 0.95960337 00:20:48.145 --> 00:20:48.885 all chemotherapy. NOTE Confidence: 0.96695894 00:20:49.505 --> 00:20:51.425 And chemotherapy can be effective NOTE Confidence: 0.96695894 00:20:51.425 --> 00:20:53.045 in cancer, but NOTE Confidence: 0.9866152 00:20:54.545 --> 00:20:55.925 it has a NOTE Confidence: 0.9967856 00:20:57.149 --> 00:20:58.590 substantial risk of side effects NOTE Confidence: 0.9967856 00:20:58.590 --> 00:21:00.049 in many patients because NOTE Confidence: 0.9995937 00:21:00.350 --> 00:21:01.090 the chemotherapy NOTE Confidence: 0.99848557 00:21:01.789 --> 00:21:03.169 isn't very good at distinguishing NOTE Confidence: 0.99841034 00:21:03.789 --> 00:21:04.289 between NOTE Confidence: 0.9990595 00:21:04.590 --> 00:21:06.049 the cancer itself NOTE Confidence: 0.9514488 00:21:06.350 --> 00:21:08.805 and a patient's normal cells. NOTE Confidence: 0.9514488 00:21:08.885 --> 00:21:10.085 It can definitely kill cancer NOTE Confidence: 0.9514488 00:21:10.085 --> 00:21:11.525 cells but also can damage NOTE Confidence: 0.9514488 00:21:11.525 --> 00:21:12.725 normal cells and that's where NOTE Confidence: 0.9514488 00:21:12.725 --> 00:21:14.105 the side effects come from. NOTE Confidence: 0.9514488 00:21:14.244 --> 00:21:15.845 And the revolution in cancer NOTE Confidence: 0.9514488 00:21:15.845 --> 00:21:17.125 care in general has come NOTE Confidence: 0.9514488 00:21:17.125 --> 00:21:18.105 about because NOTE Confidence: 0.9913765 00:21:19.525 --> 00:21:20.025 we've NOTE Confidence: 0.9702222 00:21:21.059 --> 00:21:23.240 changed our treatment paradigm in NOTE Confidence: 0.9702222 00:21:23.380 --> 00:21:24.919 many, if not most cases, NOTE Confidence: 0.99935645 00:21:25.539 --> 00:21:26.200 to drugs NOTE Confidence: 0.9962115 00:21:26.500 --> 00:21:28.600 that target something that's specific NOTE Confidence: 0.9407549 00:21:29.139 --> 00:21:30.580 within the cancer cell that's NOTE Confidence: 0.9407549 00:21:30.580 --> 00:21:31.080 not NOTE Confidence: 0.9683622 00:21:31.380 --> 00:21:33.059 present in the normal cell. NOTE Confidence: 0.9683622 00:21:33.059 --> 00:21:34.500 So this so called targeted NOTE Confidence: 0.9683622 00:21:34.500 --> 00:21:36.279 therapy, which is targeting what's NOTE Confidence: 0.9800839 00:21:36.585 --> 00:21:38.284 specifically driving the cancer, NOTE Confidence: 0.99829626 00:21:38.664 --> 00:21:40.505 tends to have substantially fewer NOTE Confidence: 0.99829626 00:21:40.505 --> 00:21:41.725 side effects because NOTE Confidence: 0.974271 00:21:42.105 --> 00:21:43.725 it is more targeted directly, NOTE Confidence: 0.9988011 00:21:44.184 --> 00:21:44.924 and specifically NOTE Confidence: 0.9836527 00:21:45.385 --> 00:21:46.605 at the cancer cells. NOTE Confidence: 0.97076136 00:21:47.065 --> 00:21:48.825 And so that's the major NOTE Confidence: 0.97076136 00:21:48.825 --> 00:21:49.325 breakthrough NOTE Confidence: 0.9748029 00:21:49.945 --> 00:21:51.145 that's happened over the last NOTE Confidence: 0.9748029 00:21:51.145 --> 00:21:52.799 ten to twenty years And NOTE Confidence: 0.9748029 00:21:52.799 --> 00:21:54.240 that's all come NOTE Confidence: 0.9748029 00:21:54.240 --> 00:21:56.740 about both from tremendous laboratory NOTE Confidence: 0.9748029 00:21:56.880 --> 00:21:58.159 research as well as all NOTE Confidence: 0.9748029 00:21:58.159 --> 00:21:59.519 the clinical trials that have NOTE Confidence: 0.9748029 00:21:59.519 --> 00:22:00.019 been NOTE Confidence: 0.997381 00:22:00.480 --> 00:22:03.200 required to translate those discoveries NOTE Confidence: 0.997381 00:22:03.200 --> 00:22:04.659 in the laboratory into NOTE Confidence: 0.77009463 00:22:04.960 --> 00:22:05.460 actual NOTE Confidence: 0.96032023 00:22:06.385 --> 00:22:08.065 drugs available for patients. NOTE Confidence: 0.96032023 00:22:08.065 --> 00:22:09.025 Ssome of the NOTE Confidence: 0.96032023 00:22:09.025 --> 00:22:10.725 big ones that have happened NOTE Confidence: 0.8465558 00:22:11.184 --> 00:22:11.684 are NOTE Confidence: 0.9328459 00:22:13.984 --> 00:22:15.605 immune therapies, which NOTE Confidence: 0.7754909 00:22:16.065 --> 00:22:16.565 enable NOTE Confidence: 0.9865275 00:22:16.945 --> 00:22:18.945 the patient's own immune system NOTE Confidence: 0.9865275 00:22:18.945 --> 00:22:20.790 to rise up and attack NOTE Confidence: 0.9865275 00:22:20.869 --> 00:22:22.490 the cancer, and that's revolutionized NOTE Confidence: 0.9865275 00:22:22.710 --> 00:22:23.369 the care NOTE Confidence: 0.92887837 00:22:23.670 --> 00:22:24.330 of many NOTE Confidence: 0.92922044 00:22:25.109 --> 00:22:26.650 cancers, including melanoma and 00:22:28.550 --> 00:22:30.310 lung cancer and kidney cancer NOTE Confidence: 0.9137522 00:22:30.310 --> 00:22:31.990 and essentially all cancers are NOTE Confidence: 0.9137522 00:22:31.990 --> 00:22:32.490 now NOTE Confidence: 0.9414273 00:22:33.030 --> 00:22:34.810 involved with using NOTE Confidence: 0.8145731 00:22:35.190 --> 00:22:35.690 immunotherapy. NOTE Confidence: 0.98462045 00:22:36.695 --> 00:22:37.494 And then we have a NOTE Confidence: 0.98462045 00:22:37.494 --> 00:22:38.635 host of oral NOTE Confidence: 0.9804158 00:22:39.415 --> 00:22:41.835 pills that target specific mutations NOTE Confidence: 0.9804158 00:22:41.895 --> 00:22:42.875 within the cancer, NOTE Confidence: 0.9968079 00:22:43.494 --> 00:22:44.315 that have NOTE Confidence: 0.8876131 00:22:44.695 --> 00:22:46.635 had huge benefits in specific NOTE Confidence: 0.96281886 00:22:47.175 --> 00:22:49.175 types of lung cancer, breast NOTE Confidence: 0.96281886 00:22:49.175 --> 00:22:49.675 cancer, NOTE Confidence: 0.9992003 00:22:50.140 --> 00:22:50.960 prostate cancer, NOTE Confidence: 0.7724323 00:22:51.820 --> 00:22:52.559 and many others. NOTE Confidence: 0.94128907 00:22:53.820 --> 00:22:54.859 And then one thing that NOTE Confidence: 0.94128907 00:22:54.859 --> 00:22:55.980 I personally have been working NOTE Confidence: 0.94128907 00:22:55.980 --> 00:22:57.500 on and now many of NOTE Confidence: 0.94128907 00:22:57.500 --> 00:22:59.359 us are working on are NOTE Confidence: 0.94128907 00:22:59.500 --> 00:23:00.780 a whole new class of NOTE Confidence: 0.94128907 00:23:00.780 --> 00:23:01.679 drug which NOTE Confidence: 0.9975788 00:23:01.980 --> 00:23:02.799 goes by NOTE Confidence: 0.97958857 00:23:03.225 --> 00:23:04.665 the scientific name of an NOTE Confidence: 0.97958857 00:23:04.665 --> 00:23:06.684 antibody drug conjugate. But essentially, NOTE Confidence: 0.97958857 00:23:06.744 --> 00:23:07.244 it's NOTE Confidence: 0.9327483 00:23:07.705 --> 00:23:08.845 a way to NOTE Confidence: 0.9955394 00:23:09.945 --> 00:23:11.645 specifically deliver chemotherapy NOTE Confidence: 0.99571234 00:23:12.025 --> 00:23:14.025 right to the cancer cell NOTE Confidence: 0.99571234 00:23:14.025 --> 00:23:15.005 using new NOTE Confidence: 0.9392344 00:23:15.350 --> 00:23:17.510 antibody technologies and that makes NOTE Confidence: 0.9392344 00:23:17.510 --> 00:23:19.030 the chemotherapy much more like NOTE Confidence: 0.9392344 00:23:19.030 --> 00:23:20.230 a guided missile or a NOTE Confidence: 0.9392344 00:23:20.230 --> 00:23:22.170 smart bomb rather than NOTE Confidence: 0.9568553 00:23:25.030 --> 00:23:26.230 a chemical that just goes NOTE Confidence: 0.9568553 00:23:26.230 --> 00:23:27.910 everywhere and damages both normal NOTE Confidence: 0.9568553 00:23:27.910 --> 00:23:29.750 tissue and cancer. So all NOTE Confidence: 0.9568553 00:23:29.750 --> 00:23:30.405 of these NOTE Confidence: 0.95820284 00:23:31.605 --> 00:23:33.445 whole classes of drugs are NOTE Confidence: 0.95820284 00:23:33.445 --> 00:23:33.945 new NOTE Confidence: 0.9995553 00:23:34.565 --> 00:23:35.065 and NOTE Confidence: 0.9854685 00:23:35.685 --> 00:23:37.045 only are possible and are NOTE Confidence: 0.9854685 00:23:37.045 --> 00:23:38.905 only available to patients because NOTE Confidence: 0.9854685 00:23:39.045 --> 00:23:39.545 of NOTE Confidence: 0.9346293 00:23:40.165 --> 00:23:41.765 all of the patients that NOTE Confidence: 0.9346293 00:23:41.765 --> 00:23:43.730 have, you know, courageously NOTE Confidence: 0.9441949 00:23:44.190 --> 00:23:44.690 elected NOTE Confidence: 0.98227483 00:23:45.470 --> 00:23:46.590 to go on to clinical NOTE Confidence: 0.98227483 00:23:46.590 --> 00:23:47.090 trials NOTE Confidence: 0.980295 00:23:47.869 --> 00:23:49.070 over the last twenty years, NOTE Confidence: 0.980295 00:23:49.309 --> 00:23:50.690 to demonstrate how NOTE Confidence: 0.97878075 00:23:51.390 --> 00:23:52.350 much of NOTE Confidence: 0.97878075 00:23:52.350 --> 00:23:53.390 a breakthrough all of these NOTE Confidence: 0.97878075 00:23:53.390 --> 00:23:55.410 drugs were, and they're now NOTE Confidence: 0.97878075 00:23:55.470 --> 00:23:56.530 standard of care. NOTE Confidence: 0.94758254 00:23:57.165 --> 00:23:58.945 It's remarkable. NOTE Confidence: 0.918697 00:23:59.725 --> 00:24:00.225 Alyssa, NOTE Confidence: 0.9983378 00:24:00.685 --> 00:24:02.205 is it more work for NOTE Confidence: 0.9983378 00:24:02.205 --> 00:24:03.244 somebody to be on a NOTE Confidence: 0.9983378 00:24:03.244 --> 00:24:04.305 clinical trial? NOTE Confidence: 0.9992022 00:24:05.485 --> 00:24:07.405 Does it require more NOTE Confidence: 0.9992022 00:24:07.405 --> 00:24:09.425 visits to the clinic? Does NOTE Confidence: 0.9992022 00:24:09.485 --> 00:24:10.145 it require NOTE Confidence: 0.9843078 00:24:11.160 --> 00:24:12.140 added expense, NOTE Confidence: 0.99858505 00:24:12.520 --> 00:24:14.540 added time from family members? NOTE Confidence: 0.95510226 00:24:16.280 --> 00:24:17.720 That's a great question, Eric. NOTE Confidence: 0.95510226 00:24:17.720 --> 00:24:19.640 And I think sometimes, yes. NOTE Confidence: 0.95510226 00:24:19.640 --> 00:24:21.340 The answer is yes. However, NOTE Confidence: 0.99862134 00:24:21.960 --> 00:24:22.619 I think the 00:24:24.680 --> 00:24:25.900 access to trials NOTE Confidence: 0.9861762 00:24:26.865 --> 00:24:28.645 is important as far as NOTE Confidence: 0.9861762 00:24:28.785 --> 00:24:30.625 there's also more oversight. NOTE Confidence: 0.97790897 00:24:32.225 --> 00:24:34.145 So the fact that NOTE Confidence: 0.97790897 00:24:34.465 --> 00:24:35.205 a patient NOTE Confidence: 0.9998988 00:24:36.305 --> 00:24:38.244 is very closely tracked NOTE Confidence: 0.99732274 00:24:38.650 --> 00:24:40.330 in research studies. There are NOTE Confidence: 0.99732274 00:24:40.330 --> 00:24:41.850 some studies that may require NOTE Confidence: 0.99732274 00:24:41.850 --> 00:24:43.290 a few additional visits. I NOTE Confidence: 0.99732274 00:24:43.290 --> 00:24:44.750 think we talked about earlier NOTE Confidence: 0.9790184 00:24:45.050 --> 00:24:46.830 the different phases of trials, NOTE Confidence: 0.9801085 00:24:47.850 --> 00:24:49.770 and some trials do have NOTE Confidence: 0.9801085 00:24:49.770 --> 00:24:51.309 more requirements, especially NOTE Confidence: 0.99831146 00:24:52.105 --> 00:24:53.385 when they're being tested for NOTE Confidence: 0.99831146 00:24:53.385 --> 00:24:54.505 safety. So there may be NOTE Confidence: 0.99831146 00:24:54.505 --> 00:24:56.825 more visits required to ensure NOTE Confidence: 0.99831146 00:24:56.825 --> 00:24:58.024 the safety of those NOTE Confidence: 0.99831146 00:24:58.024 --> 00:24:59.325 patients that are participating. NOTE Confidence: 0.9982929 00:25:00.825 --> 00:25:01.725 For expenses, NOTE Confidence: 0.9914081 00:25:03.144 --> 00:25:04.664 there are really two types NOTE Confidence: 0.9914081 00:25:04.664 --> 00:25:06.424 of costs associated with clinical NOTE Confidence: 0.9914081 00:25:06.424 --> 00:25:08.970 trials. There's routine medical costs. NOTE Confidence: 0.9914081 00:25:08.970 --> 00:25:10.170 Those are no different than NOTE Confidence: 0.9914081 00:25:10.170 --> 00:25:11.390 the standard of care. NOTE Confidence: 0.9464741 00:25:11.690 --> 00:25:13.710 And then, typically, research costs NOTE Confidence: 0.99346626 00:25:14.410 --> 00:25:16.110 are covered NOTE Confidence: 0.99887383 00:25:16.730 --> 00:25:18.010 by the sponsor, by the NOTE Confidence: 0.99887383 00:25:18.010 --> 00:25:19.390 industry, by the funder, NOTE Confidence: 0.96537775 00:25:19.770 --> 00:25:22.190 whoever is supporting that clinical NOTE Confidence: 0.96537775 00:25:22.250 --> 00:25:22.750 trial. NOTE Confidence: 0.91110057 00:25:23.225 --> 00:25:24.765 We also try to offset NOTE Confidence: 0.91110057 00:25:24.825 --> 00:25:25.325 through NOTE Confidence: 0.99826366 00:25:26.265 --> 00:25:27.405 stipends or reimbursements NOTE Confidence: 0.9915498 00:25:27.785 --> 00:25:29.005 as much as we can NOTE Confidence: 0.9915498 00:25:29.145 --> 00:25:30.045 for additional NOTE Confidence: 0.9652422 00:25:30.425 --> 00:25:32.425 transportation or additional needs that NOTE Confidence: 0.9652422 00:25:32.425 --> 00:25:33.705 might to be able to NOTE Confidence: 0.9652422 00:25:33.705 --> 00:25:35.305 provide the access to NOTE Confidence: 0.9652422 00:25:35.625 --> 00:25:37.244 our patients to those trials. 00:25:39.059 --> 00:25:40.820 Some trials do require more NOTE Confidence: 0.9987057 00:25:40.820 --> 00:25:42.419 than standard of care. Some NOTE Confidence: 0.9987057 00:25:42.419 --> 00:25:43.700 are actually in line with NOTE Confidence: 0.9987057 00:25:43.700 --> 00:25:44.919 the standard of care NOTE Confidence: 0.9887579 00:25:45.220 --> 00:25:46.980 visits and would NOTE Confidence: 0.9887579 00:25:46.980 --> 00:25:48.419 not require much more time NOTE Confidence: 0.9887579 00:25:48.419 --> 00:25:49.159 and effort. NOTE Confidence: 0.973058 00:25:50.019 --> 00:25:51.059 And I would just NOTE Confidence: 0.973058 00:25:51.059 --> 00:25:52.755 add that, you know, while NOTE Confidence: 0.973058 00:25:52.755 --> 00:25:53.955 there may be some additional NOTE Confidence: 0.973058 00:25:53.955 --> 00:25:55.315 visits involved in a clinical NOTE Confidence: 0.973058 00:25:55.315 --> 00:25:56.615 trial in some situations, NOTE Confidence: 0.97836787 00:25:57.155 --> 00:25:58.994 there's also more team members NOTE Confidence: 0.97836787 00:25:58.994 --> 00:26:00.355 involved in doing the NOTE Confidence: 0.97836787 00:26:00.355 --> 00:26:02.055 monitoring that Alyssa was mentioning. NOTE Confidence: 0.9950308 00:26:02.835 --> 00:26:03.955 So when a patient's on NOTE Confidence: 0.9950308 00:26:03.955 --> 00:26:04.915 a trial, they have a NOTE Confidence: 0.9950308 00:26:04.915 --> 00:26:05.975 bigger care team NOTE Confidence: 0.98013526 00:26:07.690 --> 00:26:08.910 available to them, NOTE Confidence: 0.99927294 00:26:09.450 --> 00:26:10.190 more nurses NOTE Confidence: 0.97939295 00:26:10.970 --> 00:26:13.210 and research coordinators who can NOTE Confidence: 0.97939295 00:26:13.210 --> 00:26:15.230 provide assistance and answer questions NOTE Confidence: 0.97939295 00:26:15.290 --> 00:26:16.510 and be more available NOTE Confidence: 0.94093573 00:26:17.130 --> 00:26:18.410 quickly if a patient has NOTE Confidence: 0.94093573 00:26:18.410 --> 00:26:20.385 questions. So it's kind of NOTE Confidence: 0.94093573 00:26:20.385 --> 00:26:21.505 an added benefit to being NOTE Confidence: 0.94093573 00:26:21.505 --> 00:26:22.465 on a trial is that there's 00:26:23.505 --> 00:26:25.685 this bigger team around to NOTE Confidence: 0.99101466 00:26:25.744 --> 00:26:27.425 support the patient, NOTE Confidence: 0.98523426 00:26:27.905 --> 00:26:29.045 while they're on the study. NOTE Confidence: 0.98675156 00:26:29.665 --> 00:26:31.665 So as we begin to NOTE Confidence: 0.98675156 00:26:31.665 --> 00:26:33.185 wind up, I'm gonna ask NOTE Confidence: 0.98675156 00:26:33.185 --> 00:26:34.165 one more question, NOTE Confidence: 0.94373745 00:26:34.545 --> 00:26:35.205 which is, NOTE Confidence: 0.83772 00:26:37.640 --> 00:26:38.140 imagine NOTE Confidence: 0.9780569 00:26:39.240 --> 00:26:41.560 you're doing a phase three NOTE Confidence: 0.9780569 00:26:41.560 --> 00:26:42.920 trial, so this is a NOTE Confidence: 0.9780569 00:26:42.920 --> 00:26:45.400 randomized trial comparing two different NOTE Confidence: 0.9780569 00:26:45.400 --> 00:26:45.900 treatments. NOTE Confidence: 0.9918668 00:26:46.920 --> 00:26:48.680 And at some point in NOTE Confidence: 0.9918668 00:26:48.680 --> 00:26:50.945 time, because these trials are NOTE Confidence: 0.9918668 00:26:51.005 --> 00:26:52.145 monitored carefully, NOTE Confidence: 0.99935144 00:26:52.765 --> 00:26:53.905 it becomes clear NOTE Confidence: 0.9993099 00:26:54.525 --> 00:26:56.605 that one treatment is better NOTE Confidence: 0.9993099 00:26:56.605 --> 00:26:57.505 than the other. NOTE Confidence: 0.9688785 00:26:58.205 --> 00:26:59.984 How was the decision made NOTE Confidence: 0.9688785 00:27:00.125 --> 00:27:01.984 to make that information available NOTE Confidence: 0.9688785 00:27:02.045 --> 00:27:04.109 to patients and potentially to NOTE Confidence: 0.9688785 00:27:04.429 --> 00:27:06.270 provide that new treatment to NOTE Confidence: 0.9688785 00:27:06.270 --> 00:27:06.770 patients? NOTE Confidence: 0.9430887 00:27:08.990 --> 00:27:10.690 So each trial NOTE Confidence: 0.98671025 00:27:12.510 --> 00:27:13.010 has NOTE Confidence: 0.9927272 00:27:13.790 --> 00:27:15.250 what's called a data safety NOTE Confidence: 0.9927272 00:27:15.309 --> 00:27:15.809 monitoring NOTE Confidence: 0.97522575 00:27:16.494 --> 00:27:18.174 committee. So a group of NOTE Confidence: 0.97522575 00:27:18.174 --> 00:27:18.674 independent, NOTE Confidence: 0.997257 00:27:19.774 --> 00:27:21.075 physicians and statisticians NOTE Confidence: 0.9849237 00:27:21.534 --> 00:27:22.755 who follow NOTE Confidence: 0.98476124 00:27:23.135 --> 00:27:24.434 the course of the trial, NOTE Confidence: 0.97559667 00:27:25.054 --> 00:27:25.875 very closely NOTE Confidence: 0.924176 00:27:26.975 --> 00:27:27.934 as it goes on in a phase 00:27:29.149 --> 00:27:30.529 III trial like you're mentioning NOTE Confidence: 0.8748367 00:27:30.909 --> 00:27:32.429 can go on for multiple NOTE Confidence: 0.8748367 00:27:32.429 --> 00:27:32.929 years. NOTE Confidence: 0.64624316 00:27:33.389 --> 00:27:34.210 And this NOTE Confidence: 0.7244377 00:27:34.909 --> 00:27:35.409 committee NOTE Confidence: 0.9699218 00:27:36.109 --> 00:27:37.389 looks at those kinds of NOTE Confidence: 0.9699218 00:27:37.389 --> 00:27:38.929 results that you're talking about NOTE Confidence: 0.9699218 00:27:39.149 --> 00:27:41.630 on a regular continuous basis. NOTE Confidence: 0.9699218 00:27:41.630 --> 00:27:42.769 And if they see NOTE Confidence: 0.9065597 00:27:43.595 --> 00:27:44.575 a clear winner NOTE Confidence: 0.97797054 00:27:45.115 --> 00:27:46.715 in a trial like that, NOTE Confidence: 0.97797054 00:27:46.715 --> 00:27:48.155 they have the authority to NOTE Confidence: 0.97797054 00:27:48.155 --> 00:27:49.595 stop the trial at that NOTE Confidence: 0.97797054 00:27:49.595 --> 00:27:50.095 point. NOTE Confidence: 0.7142397 00:27:51.035 --> 00:27:51.535 And NOTE Confidence: 0.9629955 00:27:51.835 --> 00:27:53.115 depending on the situation, if NOTE Confidence: 0.9629955 00:27:53.115 --> 00:27:54.075 they feel like it's in NOTE Confidence: 0.9629955 00:27:54.075 --> 00:27:54.895 the best interests NOTE Confidence: 0.9764802 00:27:55.275 --> 00:27:56.255 of the participants, NOTE Confidence: 0.9965006 00:27:57.755 --> 00:27:58.494 can then NOTE Confidence: 0.99840707 00:27:58.980 --> 00:28:00.820 allow the patients who were NOTE Confidence: 0.99840707 00:28:00.820 --> 00:28:01.320 on NOTE Confidence: 0.99932647 00:28:01.700 --> 00:28:02.200 the NOTE Confidence: 0.94707394 00:28:02.580 --> 00:28:03.480 standard drug NOTE Confidence: 0.84016013 00:28:04.260 --> 00:28:04.760 that NOTE Confidence: 0.9954236 00:28:05.380 --> 00:28:06.680 turned out not to be NOTE Confidence: 0.9748661 00:28:07.859 --> 00:28:08.820 the best one, that the NOTE Confidence: 0.9748661 00:28:08.820 --> 00:28:11.080 newer drug was clearly better, NOTE Confidence: 0.9748661 00:28:11.220 --> 00:28:12.760 they have the authority to NOTE Confidence: 0.9611021 00:28:13.774 --> 00:28:15.455 mandate that the patients who NOTE Confidence: 0.9611021 00:28:15.455 --> 00:28:16.734 who were not receiving NOTE Confidence: 0.9611021 00:28:16.734 --> 00:28:17.934 the newer drug can then NOTE Confidence: 0.9611021 00:28:17.934 --> 00:28:19.475 switch over, we call crossover, NOTE Confidence: 0.9920464 00:28:20.335 --> 00:28:21.615 to the newer drug NOTE Confidence: 0.9920464 00:28:21.615 --> 00:28:23.135 to get access NOTE Confidence: 0.9920464 00:28:23.135 --> 00:28:23.774 to that NOTE Confidence: 0.9893907 00:28:24.255 --> 00:28:26.414 superior therapy right away rather NOTE Confidence: 0.9893907 00:28:26.414 --> 00:28:27.455 than have to wait for NOTE Confidence: 0.9893907 00:28:27.455 --> 00:28:28.494 the drug to get approved NOTE Confidence: 0.9893907 00:28:28.494 --> 00:28:29.315 by the FDA. NOTE Confidence: 0.9396399 00:28:30.070 --> 00:28:31.510 Doctor Ian Krop is a NOTE Confidence: 0.9396399 00:28:31.510 --> 00:28:33.110 professor of internal medicine and NOTE Confidence: 0.9396399 00:28:33.110 --> 00:28:34.710 medical oncology at the Yale NOTE Confidence: 0.9396399 00:28:34.710 --> 00:28:36.470 School of Medicine, and Alyssa NOTE Confidence: 0.9396399 00:28:36.470 --> 00:28:38.070 Gateman is the executive director NOTE Confidence: 0.9396399 00:28:38.070 --> 00:28:39.510 of the clinical trials office NOTE Confidence: 0.9396399 00:28:39.510 --> 00:28:40.970 at Yale Cancer Center. NOTE Confidence: 0.96354944 00:28:41.350 --> 00:28:42.550 If you have questions, the NOTE Confidence: 0.96354944 00:28:42.550 --> 00:28:43.610 address is canceranswers NOTE Confidence: 0.98192585 00:28:43.955 --> 00:28:44.995 answers at yale dot e NOTE Confidence: 0.98192585 00:28:44.995 --> 00:28:46.515 d u, and past editions NOTE Confidence: 0.98192585 00:28:46.515 --> 00:28:47.875 of the program are available NOTE Confidence: 0.98192585 00:28:47.875 --> 00:28:49.395 in audio and written form NOTE Confidence: 0.98192585 00:28:49.395 --> 00:28:50.755 at yale cancer center dot NOTE Confidence: 0.98192585 00:28:50.755 --> 00:28:52.275 org. We hope you'll join NOTE Confidence: 0.98192585 00:28:52.275 --> 00:28:53.395 us next time to learn NOTE Confidence: 0.98192585 00:28:53.395 --> 00:28:54.515 more about the fight against NOTE Confidence: 0.98192585 00:28:54.515 --> 00:28:56.595 cancer. Funding for Yale Cancer NOTE Confidence: 0.98192585 00:28:56.595 --> 00:28:58.195 Answers is provided by Smilow NOTE Confidence: 0.98192585 00:28:58.195 --> 00:28:59.095 Cancer Hospital.