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Increasing Access to Clinical Trials

January 13, 2025
00:00
00:00
29:00
  • 00:00Funding for Yale Cancer Answers
  • 00:02is provided by Smilow Cancer
  • 00:04Hospital.
  • 00:06Welcome to Yale Cancer Answers
  • 00:08with the director of
  • 00:09Yale Cancer Center, Doctor Eric
  • 00:11Winer.
  • 00:12Yale Cancer Answers features conversations
  • 00:14with oncologists and specialists who
  • 00:16are on the forefront of
  • 00:17the battle to fight cancer.
  • 00:19This week, it's a conversation
  • 00:20about clinical trials with doctor
  • 00:22Ian Krop and Alyssa Gateman.
  • 00:24Doctor Krop is a professor
  • 00:25of internal medicine and medical
  • 00:27oncology at the Yale School
  • 00:28of Medicine, and Alyssa Gateman
  • 00:30is the executive director of
  • 00:32the clinical trials office at
  • 00:33Yale Cancer Center. Here's
  • 00:35doctor Winer.
  • 00:38Let's just begin talking
  • 00:39a little bit about each
  • 00:41of you and how you
  • 00:42got interested in this line
  • 00:44of work.
  • 00:45Alyssa, how'd you wind
  • 00:47up working in clinical trials?
  • 00:49Thank you, Eric.
  • 00:51I fell into clinical trials
  • 00:53about twenty five years ago.
  • 00:56The first part of
  • 00:57my career, I was working
  • 00:59with investigators
  • 01:00on studies that they developed
  • 01:01themselves and really on the
  • 01:03data side. But for the
  • 01:04majority of my career, I
  • 01:05have been working in quality
  • 01:09and compliance, really ensuring that
  • 01:11our patients that
  • 01:14are participating in research studies
  • 01:16are protected,
  • 01:18that they have been provided informed
  • 01:19consent, and that the data
  • 01:21that they're providing
  • 01:23to lead to new treatments
  • 01:24is actually collected and credible data.
  • 01:27A few years ago, as
  • 01:28you know, I transitioned
  • 01:30now over more to operations
  • 01:31and administration.
  • 01:34But one of the passions I
  • 01:36have is really educating
  • 01:38new clinical research professionals and
  • 01:40making everyone aware
  • 01:42as they're trying to go
  • 01:44through their professions and look
  • 01:46at what their career options
  • 01:47are of the options of being
  • 01:48a clinical research professional.
  • 01:54An Ian, wha
  • 01:54got you into this?
  • 01:57You are also
  • 01:59a clinician and a researcher.
  • 02:04What made you interested in
  • 02:05cancer, and what got you
  • 02:08involved in clinical
  • 02:10trials?
  • 02:12Personally I didn't fall into clinical trials.
  • 02:14I think I more gradually
  • 02:15crawled into this area.
  • 02:19I was originally
  • 02:20a laboratory
  • 02:21researcher trying to understand
  • 02:24what causes cancer, what causes
  • 02:26cancer to become resistant
  • 02:29to our treatments.
  • 02:31But over time, I
  • 02:34wanted to more directly
  • 02:38impact patients and have
  • 02:40the research
  • 02:42help patients directly rather than
  • 02:45the gradual process of laboratory
  • 02:46research. So I started doing
  • 02:48more and more
  • 02:50clinical trials, testing new drugs
  • 02:51to help
  • 02:52patients
  • 02:53with breast cancer, and
  • 02:55that just became
  • 02:58such an exciting field.
  • 03:01I couldn't leave it until
  • 03:03it became my full time
  • 03:04job, roughly twenty
  • 03:05years ago and have
  • 03:06continued to do that moving
  • 03:08from Boston
  • 03:10now here to Yale,
  • 03:11two and a half years
  • 03:12ago.
  • 03:14Well, clinical trials are obviously
  • 03:16very important
  • 03:18because there is no scientific
  • 03:20discovery that goes from
  • 03:22some scientist's
  • 03:23lab
  • 03:24to the pharmacy
  • 03:26shelf without a clinical trials
  • 03:28component
  • 03:29in between.
  • 03:30With that said,
  • 03:32what's involved for a patient
  • 03:34in joining a clinical trial?
  • 03:36It's a great question
  • 03:39because it's not
  • 03:41something that you necessarily are
  • 03:43gonna know unless you've
  • 03:45been involved.
  • 03:47I don't think many of the
  • 03:49medicine shows on TV really
  • 03:51talk about
  • 03:52clinical trials, so
  • 03:54happy to explain.
  • 03:57For most patients,
  • 04:01getting involved in a clinical
  • 04:02trial starts
  • 04:03in their discussions
  • 04:05with their healthcare provider about
  • 04:08what treatments makes sense for
  • 04:10them,
  • 04:11as in the next step
  • 04:15of their journey.
  • 04:17And we
  • 04:18really feel strongly that a
  • 04:20clinical trial is part of the
  • 04:25overall treatment options available to
  • 04:28patients.
  • 04:29And so when
  • 04:30a patient is deciding
  • 04:32on what treatment option to
  • 04:34take,
  • 04:35the providers
  • 04:37provide that
  • 04:38treatment, a clinical trial option,
  • 04:40as well as what we
  • 04:41call standard of care, the
  • 04:42FDA approved
  • 04:43options.
  • 04:48If the trial is of interest
  • 04:50to the patient,
  • 04:51we then go into more
  • 04:53detail about
  • 04:54about
  • 04:55what's involved with the trial.
  • 04:58We go over what's called
  • 04:59the informed consent document that
  • 05:01Alyssa mentioned earlier, which is
  • 05:03basically
  • 05:05a very in-depth description of
  • 05:07what's involved in the trial,
  • 05:09both what procedures and steps
  • 05:12and visits are required, but
  • 05:13also most importantly the rationale
  • 05:15for the and the
  • 05:17potential benefits and the potential
  • 05:19risks.
  • 05:22After the patients read that
  • 05:26and talk with their family
  • 05:27and talk with their provider,
  • 05:28if they decide they are
  • 05:30wanting to participate in the
  • 05:31trial, they would then sign
  • 05:33the consent.
  • 05:34Then we would as a team,
  • 05:38make sure that the patient
  • 05:40meets what's called the eligibility
  • 05:41of the trial, which is
  • 05:42all the
  • 05:44criteria
  • 05:45that the patients,
  • 05:47who the physicians who design
  • 05:49the trial,
  • 05:50feel are important from
  • 05:52both the question that's
  • 05:54being answered as well as
  • 05:55the safety for the patients
  • 05:57that they need to meet
  • 05:58those criteria to be eligible
  • 06:00for the trial. If they
  • 06:01are found to be eligible,
  • 06:03then they go ahead and
  • 06:06start the trial
  • 06:08and continue on the trial
  • 06:10as part of their
  • 06:11treatment. So it's not
  • 06:15oftentimes in addition to their
  • 06:16treatment,
  • 06:18that's going to be their
  • 06:19treatment for the
  • 06:20period of time that they're
  • 06:21on the trial.
  • 06:23Alyssa, maybe
  • 06:24you can comment on this.
  • 06:26It seems to me that
  • 06:28people who have cancer
  • 06:31are often in a vulnerable
  • 06:33position.
  • 06:34They are frightened.
  • 06:36They sometimes, if newly diagnosed,
  • 06:39are just overwhelmed
  • 06:41by information.
  • 06:43And making a decision about
  • 06:45participating in a clinical trial
  • 06:47can be tough, and
  • 06:50you could also imagine
  • 06:52that patients at times
  • 06:55might feel pressured by
  • 06:58someone, a family member,
  • 07:01hopefully not a doctor,
  • 07:03but someone to participate in
  • 07:04the trial. How do we
  • 07:05protect people from that sort
  • 07:07of thing?
  • 07:09Yeah. So I think, Eric,
  • 07:11it is, as you said,
  • 07:12a scary time a lot
  • 07:14of times
  • 07:15especially in oncology.
  • 07:19There's a lot of information
  • 07:20coming at them. I think
  • 07:22we wanna make sure that
  • 07:23our patients feel empowered to
  • 07:25be able to ask questions
  • 07:26of both of their providers,
  • 07:28and, also, we have clinical
  • 07:29trial office coordinators and nurses
  • 07:32that are there for additional
  • 07:34questions and logistics.
  • 07:35But we also have
  • 07:38patients whose rights are
  • 07:39protected. So any clinical research
  • 07:42trial
  • 07:43that's ongoing, as Ian had
  • 07:45mentioned, there's the informed consent.
  • 07:47That informed consent is reviewed
  • 07:49by what we call an
  • 07:50institutional review board
  • 07:52that reviews things for ethical
  • 07:55reasons, but then also really
  • 07:56make sure it
  • 07:58accurately
  • 07:59captures the information of that
  • 08:01trial so they do have
  • 08:02the information to take home.
  • 08:04And it's really in the
  • 08:06patient's rights to have that
  • 08:07informed consent and all their
  • 08:09questions answered.
  • 08:10So it should be a
  • 08:11process. It's not a, this
  • 08:13is presented to you and they need a
  • 08:14yes or no right away.
  • 08:18You can take that back,
  • 08:19take it to your
  • 08:20family, friends, trusted
  • 08:24folks to be able to
  • 08:26get their questions answered and really
  • 08:28be thoughtful
  • 08:29as part of that process.
  • 08:31Also, after joining in a
  • 08:34clinical trial, if you agree
  • 08:35to participate,
  • 08:36it is in that
  • 08:38patient rights to withdraw
  • 08:40at any time,
  • 08:41and to have that discussion.
  • 08:43And that won't impact future
  • 08:45decisions,
  • 08:47with that ability to withdraw.
  • 08:49You know, I often tell
  • 08:50patients
  • 08:52that the clinical trials
  • 08:54that we have are not
  • 08:55clinical trials that some doctor
  • 08:58or other researcher
  • 09:00dreamt up some night and
  • 09:01then put on paper the
  • 09:03next morning and offered to
  • 09:04patients the next day, that
  • 09:08these are
  • 09:09ideas that have been developed
  • 09:11and have been reviewed and
  • 09:13reviewed and reviewed by multiple
  • 09:16groups of people,
  • 09:18sometimes on a national level,
  • 09:20sometimes on a
  • 09:22local level, but in all
  • 09:24cases, they are very carefully
  • 09:26vetted.
  • 09:27What kind of review
  • 09:29process
  • 09:30goes on
  • 09:32locally
  • 09:33when we have a
  • 09:34clinical trial?
  • 09:36Yeah. So I think
  • 09:37that's a very
  • 09:38good point.
  • 09:41It is quite a
  • 09:42thorough vetting process. There are
  • 09:45multiple committees,
  • 09:46both
  • 09:47committees made up of the
  • 09:49experts of
  • 09:52the cancer type that's
  • 09:53being evaluated in the clinical
  • 09:55trial,
  • 09:57as well
  • 09:58as experts in a number
  • 10:00of other fields such as
  • 10:01statistics and
  • 10:05logistics of the trial to
  • 10:06make sure it's feasible.
  • 10:08And then you have, as
  • 10:10Alyssa mentioned, the Institutional Review
  • 10:13Board, which is looking more
  • 10:14at the ethics of the
  • 10:16study and making sure patients
  • 10:17are fully educated about the
  • 10:19trial.
  • 10:20And that consists of both
  • 10:22medical professionals,
  • 10:23research professionals,
  • 10:25and community
  • 10:27representatives to fully
  • 10:31have the perspective
  • 10:33of our community involved in
  • 10:35deciding whether a trial is
  • 10:36appropriate to move forward.
  • 10:38And all of those things are
  • 10:38done both to protect the
  • 10:40patient, but also to make
  • 10:42sure that the trial is
  • 10:43being done in a way
  • 10:44that's
  • 10:45optimally designed to be able
  • 10:47to answer the question
  • 10:49that's being asked, because
  • 10:50we're asking patients
  • 10:52to give up of their
  • 10:53time
  • 10:55to participate in the trial.
  • 10:57Trials are very expensive.
  • 10:58So there's a lot that
  • 11:00is involved in the trial.
  • 11:01And so we at the
  • 11:02end, we really wanna make
  • 11:03sure that we're definitively
  • 11:05answering
  • 11:06an important question to be
  • 11:07able to
  • 11:08help our patients moving forward
  • 11:10and improve the treatment for
  • 11:12the next
  • 11:13generation of patients.
  • 11:16Now
  • 11:16we know that there are
  • 11:18many different kinds of trials,
  • 11:19and there are trials that
  • 11:20go from being
  • 11:22somewhat more investigational
  • 11:24to somewhat
  • 11:27more like standard treatment where
  • 11:29we're just bearing one small
  • 11:30component to try to see
  • 11:32if we can make a
  • 11:33treatment a little less toxic
  • 11:36or a little bit more
  • 11:37effective.
  • 11:38So we often refer to
  • 11:40these as phase one and
  • 11:41phase two and phase three
  • 11:42trials.
  • 11:43Could you tell us a
  • 11:44little bit about
  • 11:45what each of those
  • 11:48consists of?
  • 11:50In a very
  • 11:51concise way,
  • 11:53the first trial
  • 11:54is a phase one trial
  • 11:56where we're initially looking at
  • 11:58a drug for the first
  • 11:58time in patients and that's
  • 12:00purely just making sure that
  • 12:02it's safe to give the
  • 12:03drug and that we figure
  • 12:04out what the right dose is.
  • 12:06That's a small trial with
  • 12:07generally maybe only twenty or
  • 12:09thirty patients.
  • 12:11And if I can
  • 12:12just interrupt and to be
  • 12:13clear, that's the endpoint of
  • 12:15the trial, although when a
  • 12:16doctor is treating a patient,
  • 12:18it's with the hope that
  • 12:19that drug will help someone.
  • 12:21That is correct.
  • 12:23And that is also looked
  • 12:24at in the trial. But
  • 12:25as you said, the
  • 12:26primary purpose is to just
  • 12:28establish the safety and the
  • 12:30right dose.
  • 12:31Nowadays, because our
  • 12:32drugs are so
  • 12:34sophisticated, as soon as they
  • 12:35come out of the lab,
  • 12:36oftentimes, we actually see, you
  • 12:38know, a great deal of
  • 12:40effectiveness in that even in
  • 12:41that first trial.
  • 12:43And in a phase two
  • 12:44trial?
  • 12:46So a phase two trial
  • 12:47is a slightly larger trial
  • 12:49where we're now really trying
  • 12:50to focus on how effective
  • 12:52that drug is,
  • 12:53for that particular patient population.
  • 12:56And then if it shows
  • 12:57to be
  • 12:59effective
  • 13:00and promising, it then moves
  • 13:01to a phase three trial
  • 13:02where that trial drug is
  • 13:04being compared
  • 13:05to the current standard of
  • 13:07care to see which one
  • 13:08actually is more effective.
  • 13:11Well, that is very helpful.
  • 13:14We're gonna just take a
  • 13:15very brief break, and we'll
  • 13:17be back with our guests
  • 13:19Alyssa Gateman and Ian Krop
  • 13:21in just a minute.
  • 13:23Funding for Yale Cancer Answers
  • 13:25comes from Smilow Cancer Hospital,
  • 13:27where the Lung Cancer Screening
  • 13:29Program provides screening to those
  • 13:30at risk for lung cancer
  • 13:32and individualized
  • 13:33state of the art evaluation
  • 13:35of lung nodules.
  • 13:36To learn more, visit smilowcancerhospital
  • 13:39dot org.
  • 13:41Over two hundred and thirty
  • 13:43thousand Americans will be diagnosed
  • 13:45with lung cancer this year,
  • 13:46and in Connecticut alone, there
  • 13:48will be over twenty seven
  • 13:49hundred new cases.
  • 13:51More than eighty five percent
  • 13:52of lung cancer diagnoses are
  • 13:54related to smoking,
  • 13:56and quitting, even after decades
  • 13:57of use can significantly reduce
  • 13:59your risk of developing lung
  • 14:01cancer.
  • 14:02Each day, patients with lung
  • 14:03cancer are surviving thanks to
  • 14:05increased access to advanced therapies
  • 14:07and specialized care.
  • 14:09New treatment options and surgical
  • 14:11techniques are giving lung cancer
  • 14:12survivors more hope than they
  • 14:14have ever had before.
  • 14:15Clinical trials are currently underway
  • 14:17at federally designated comprehensive cancer
  • 14:20centers
  • 14:21such as the battle two
  • 14:22trial at Yale Cancer Center
  • 14:24and Smilow Cancer Hospital,
  • 14:26to learn if a drug
  • 14:27or combination of drugs based
  • 14:29on personal biomarkers
  • 14:30can help to control non
  • 14:32small cell lung cancer.
  • 14:34More information is available at
  • 14:35yale cancer center dot org.
  • 14:37You're listening to Connecticut Public
  • 14:39Radio.
  • 14:40Good evening again. This is
  • 14:42Eric Winer. I'm the director
  • 14:44of Yale Cancer Center,
  • 14:46and I'm here tonight on
  • 14:49Yale Cancer Answers with my
  • 14:50guests
  • 14:51doctor Ian Krop
  • 14:54who is the director of
  • 14:55the clinical trials office, and
  • 14:57Alyssa Gateman, the executive director
  • 14:59of the clinical trials office.
  • 15:02Alyssa, maybe I can start
  • 15:03with you.
  • 15:07Why is it important
  • 15:09that
  • 15:10we include a diverse group
  • 15:12of people in clinical trials?
  • 15:14I think there's been a
  • 15:15tendency in years past
  • 15:18for our clinical trials population
  • 15:20to look a little homogeneous,
  • 15:21and we're all worried about
  • 15:23that. And we wanna make
  • 15:24sure that that's something that
  • 15:27that doesn't continue.
  • 15:31So diversity
  • 15:32and inclusion in our clinical
  • 15:33trials is extremely important. At
  • 15:36the end of the day,
  • 15:37our clinical research
  • 15:39is putting new products and
  • 15:40new treatments out for the
  • 15:43population. So what we're really
  • 15:44looking for is
  • 15:46generalizability
  • 15:47of research results.
  • 15:49If we have a homogeneous
  • 15:51population,
  • 15:52we only really get answers
  • 15:53on that population on how
  • 15:55it works. And there are
  • 15:56differences. There's differences between genders.
  • 15:59There's differences between ages. There's
  • 16:01differences between racial and ethnic
  • 16:03groups.
  • 16:04So ensuring that the entire
  • 16:06population that's going to be
  • 16:08treated with that product potentially
  • 16:10is included in those research
  • 16:12studies,
  • 16:13is really important so that
  • 16:15we can understand all the
  • 16:16different potential side effects and
  • 16:18the different effectiveness
  • 16:20for those patients that ultimately
  • 16:22may be receiving those therapies.
  • 16:25And
  • 16:26we and others have pushed
  • 16:27very hard to
  • 16:29make sure that
  • 16:31our clinical trials do include
  • 16:33a diverse group of patients.
  • 16:35And, of course, there have been
  • 16:37research findings over the past
  • 16:39couple of decades that have
  • 16:41shown that
  • 16:42many people who are from
  • 16:44underrepresented backgrounds just don't get
  • 16:46offered clinical trials as often
  • 16:48as others, and so
  • 16:50we really try to do
  • 16:51that as do people around
  • 16:53the country.
  • 16:55I wanna move on to
  • 16:56talk for a minute about
  • 16:57myths about clinical trials.
  • 17:03Ian,
  • 17:04I'm sure you've had patients
  • 17:06say to you over the
  • 17:07years,
  • 17:09doctor Krop,
  • 17:10don't you just wanna
  • 17:12use me as a guinea
  • 17:14pig?
  • 17:15And
  • 17:16how do you answer that
  • 17:18question?
  • 17:22I think that's an important
  • 17:24point to clarify
  • 17:25because there is that myth
  • 17:27out there.
  • 17:28And I think as Alyssa very
  • 17:35eloquently stated, how important it is for
  • 17:42anybody on a trial
  • 17:43that their rights are protected
  • 17:45and that the safety
  • 17:47of them is paramount
  • 17:49and an enormous amount
  • 17:50of work goes into making
  • 17:52sure that is actually
  • 17:53the case.
  • 17:55But, you know,
  • 17:57again, I think a
  • 17:57clinical trial,
  • 18:00particularly
  • 18:02in this day and age,
  • 18:04is the way to get
  • 18:07access to the
  • 18:09most cutting edge treatments,
  • 18:13and I think
  • 18:14those of us
  • 18:17at Yale Cancer Center
  • 18:18feel that a clinical trial
  • 18:19is really part of
  • 18:24top quality
  • 18:27cancer care now,
  • 18:29having access to clinical trials
  • 18:31is really
  • 18:32critical,
  • 18:34for that.
  • 18:36And getting back to
  • 18:37your previous question about the
  • 18:39need to make sure that
  • 18:40we have a diverse population,
  • 18:42I think not only do
  • 18:43we need a diverse population
  • 18:44in our clinical trials so
  • 18:45that we can make sure
  • 18:46that the results we get
  • 18:47are applicable to all groups,
  • 18:50I think it's also
  • 18:52a disparities issue. I think
  • 18:54if people don't have
  • 18:56access to
  • 18:57clinical trials,
  • 18:59where they're being seen,
  • 19:00they don't have access to
  • 19:03to the optimal care.
  • 19:04And I think that's
  • 19:06another reason why
  • 19:07at Yale Cancer Center we try to
  • 19:09make sure we have access
  • 19:10to clinical trials for our
  • 19:11patients across all
  • 19:13of our sites
  • 19:15across Connecticut.
  • 19:16And while there are obviously
  • 19:19no guarantees
  • 19:20when someone receives a standard
  • 19:22treatment or
  • 19:23when they're on a clinical
  • 19:25trial, the
  • 19:27hope when people
  • 19:28develop clinical trials is that
  • 19:30the treatment is actually going
  • 19:32to be better in one
  • 19:33way or another.
  • 19:35We don't go into clinical
  • 19:37trials
  • 19:38intending
  • 19:39to come up with a
  • 19:40worse result, and it doesn't
  • 19:42happen
  • 19:43very often. Although, again, there
  • 19:45can be no guarantees.
  • 19:50Can you give us some
  • 19:51examples
  • 19:53of some of the breakthroughs
  • 19:55we've seen in the last
  • 19:56five to ten years,
  • 19:58and,
  • 20:00there are many
  • 20:01that have come about as
  • 20:03a result of clinical trials.
  • 20:06Yeah. I would
  • 20:07argue that essentially all of
  • 20:09the breakthroughs that have happened
  • 20:10in the last five or
  • 20:12ten years
  • 20:14are as a result of
  • 20:15clinical trials. As you said
  • 20:17in the introduction, a
  • 20:19drug doesn't go from the
  • 20:21laboratory
  • 20:22to the pharmacy.
  • 20:23It only gets to
  • 20:25a place where patients can
  • 20:27access it through clinical trials.
  • 20:30And,
  • 20:31you know,
  • 20:33twenty years ago when I
  • 20:34started in this field, or
  • 20:35actually, now it's twenty five
  • 20:37years ago,
  • 20:38time flies,
  • 20:40you know, we were
  • 20:42in breast cancer, for example,
  • 20:44in almost all cancers,
  • 20:46the treatments available were essentially
  • 20:48all chemotherapy.
  • 20:50And chemotherapy can be effective
  • 20:51in cancer, but
  • 20:55it has a
  • 20:57substantial risk of side effects
  • 20:59in many patients because
  • 21:00the chemotherapy
  • 21:02isn't very good at distinguishing
  • 21:04between
  • 21:05the cancer itself
  • 21:06and a patient's normal cells.
  • 21:09It can definitely kill cancer
  • 21:10cells but also can damage
  • 21:12normal cells and that's where
  • 21:13the side effects come from.
  • 21:14And the revolution in cancer
  • 21:16care in general has come
  • 21:17about because
  • 21:20we've
  • 21:21changed our treatment paradigm in
  • 21:23many, if not most cases,
  • 21:26to drugs
  • 21:27that target something that's specific
  • 21:29within the cancer cell that's
  • 21:31not
  • 21:31present in the normal cell.
  • 21:33So this so called targeted
  • 21:35therapy, which is targeting what's
  • 21:37specifically driving the cancer,
  • 21:39tends to have substantially fewer
  • 21:41side effects because
  • 21:42it is more targeted directly,
  • 21:44and specifically
  • 21:45at the cancer cells.
  • 21:47And so that's the major
  • 21:49breakthrough
  • 21:50that's happened over the last
  • 21:51ten to twenty years And
  • 21:53that's all come
  • 21:54about both from tremendous laboratory
  • 21:57research as well as all
  • 21:58the clinical trials that have
  • 22:00been
  • 22:00required to translate those discoveries
  • 22:03in the laboratory into
  • 22:05actual
  • 22:06drugs available for patients.
  • 22:08Ssome of the
  • 22:09big ones that have happened
  • 22:11are
  • 22:14immune therapies, which
  • 22:16enable
  • 22:17the patient's own immune system
  • 22:19to rise up and attack
  • 22:21the cancer, and that's revolutionized
  • 22:23the care
  • 22:24of many
  • 22:25cancers, including melanoma and
  • 22:29lung cancer and kidney cancer
  • 22:30and essentially all cancers are
  • 22:32now
  • 22:33involved with using
  • 22:35immunotherapy.
  • 22:37And then we have a
  • 22:37host of oral
  • 22:39pills that target specific mutations
  • 22:42within the cancer,
  • 22:43that have
  • 22:45had huge benefits in specific
  • 22:47types of lung cancer, breast
  • 22:49cancer,
  • 22:50prostate cancer,
  • 22:52and many others.
  • 22:54And then one thing that
  • 22:55I personally have been working
  • 22:56on and now many of
  • 22:58us are working on are
  • 23:00a whole new class of
  • 23:01drug which
  • 23:02goes by
  • 23:03the scientific name of an
  • 23:05antibody drug conjugate. But essentially,
  • 23:07it's
  • 23:08a way to
  • 23:10specifically deliver chemotherapy
  • 23:12right to the cancer cell
  • 23:14using new
  • 23:15antibody technologies and that makes
  • 23:18the chemotherapy much more like
  • 23:19a guided missile or a
  • 23:20smart bomb rather than
  • 23:25a chemical that just goes
  • 23:26everywhere and damages both normal
  • 23:28tissue and cancer. So all
  • 23:30of these
  • 23:32whole classes of drugs are
  • 23:33new
  • 23:35and
  • 23:36only are possible and are
  • 23:37only available to patients because
  • 23:39of
  • 23:40all of the patients that
  • 23:42have, you know, courageously
  • 23:44elected
  • 23:45to go on to clinical
  • 23:47trials
  • 23:48over the last twenty years,
  • 23:49to demonstrate how
  • 23:51much of
  • 23:52a breakthrough all of these
  • 23:53drugs were, and they're now
  • 23:55standard of care.
  • 23:57It's remarkable.
  • 24:00Alyssa,
  • 24:01is it more work for
  • 24:02somebody to be on a
  • 24:03clinical trial?
  • 24:05Does it require more
  • 24:07visits to the clinic? Does
  • 24:09it require
  • 24:11added expense,
  • 24:13added time from family members?
  • 24:16That's a great question, Eric.
  • 24:18And I think sometimes, yes.
  • 24:20The answer is yes. However,
  • 24:22I think the
  • 24:25access to trials
  • 24:27is important as far as
  • 24:29there's also more oversight.
  • 24:32So the fact that
  • 24:34a patient
  • 24:36is very closely tracked
  • 24:39in research studies. There are
  • 24:40some studies that may require
  • 24:42a few additional visits. I
  • 24:43think we talked about earlier
  • 24:45the different phases of trials,
  • 24:48and some trials do have
  • 24:50more requirements, especially
  • 24:52when they're being tested for
  • 24:53safety. So there may be
  • 24:55more visits required to ensure
  • 24:57the safety of those
  • 24:58patients that are participating.
  • 25:01For expenses,
  • 25:03there are really two types
  • 25:05of costs associated with clinical
  • 25:06trials. There's routine medical costs.
  • 25:09Those are no different than
  • 25:10the standard of care.
  • 25:12And then, typically, research costs
  • 25:14are covered
  • 25:17by the sponsor, by the
  • 25:18industry, by the funder,
  • 25:20whoever is supporting that clinical
  • 25:22trial.
  • 25:23We also try to offset
  • 25:25through
  • 25:26stipends or reimbursements
  • 25:28as much as we can
  • 25:29for additional
  • 25:30transportation or additional needs that
  • 25:32might to be able to
  • 25:34provide the access to
  • 25:36our patients to those trials.
  • 25:39Some trials do require more
  • 25:41than standard of care. Some
  • 25:42are actually in line with
  • 25:44the standard of care
  • 25:45visits and would
  • 25:47not require much more time
  • 25:48and effort.
  • 25:50And I would just
  • 25:51add that, you know, while
  • 25:53there may be some additional
  • 25:54visits involved in a clinical
  • 25:55trial in some situations,
  • 25:57there's also more team members
  • 25:59involved in doing the
  • 26:00monitoring that Alyssa was mentioning.
  • 26:03So when a patient's on
  • 26:04a trial, they have a
  • 26:05bigger care team
  • 26:08available to them,
  • 26:09more nurses
  • 26:11and research coordinators who can
  • 26:13provide assistance and answer questions
  • 26:15and be more available
  • 26:17quickly if a patient has
  • 26:18questions. So it's kind of
  • 26:20an added benefit to being
  • 26:22on a trial is that there's
  • 26:24this bigger team around to
  • 26:26support the patient,
  • 26:28while they're on the study.
  • 26:30So as we begin to
  • 26:32wind up, I'm gonna ask
  • 26:33one more question,
  • 26:35which is,
  • 26:38imagine
  • 26:39you're doing a phase three
  • 26:42trial, so this is a
  • 26:43randomized trial comparing two different
  • 26:45treatments.
  • 26:47And at some point in
  • 26:49time, because these trials are
  • 26:51monitored carefully,
  • 26:53it becomes clear
  • 26:55that one treatment is better
  • 26:57than the other.
  • 26:58How was the decision made
  • 27:00to make that information available
  • 27:02to patients and potentially to
  • 27:04provide that new treatment to
  • 27:06patients?
  • 27:09So each trial
  • 27:13has
  • 27:14what's called a data safety
  • 27:15monitoring
  • 27:16committee. So a group of
  • 27:18independent,
  • 27:20physicians and statisticians
  • 27:22who follow
  • 27:23the course of the trial,
  • 27:25very closely
  • 27:27as it goes on in a phase
  • 27:29III trial like you're mentioning
  • 27:31can go on for multiple
  • 27:32years.
  • 27:33And this
  • 27:35committee
  • 27:36looks at those kinds of
  • 27:37results that you're talking about
  • 27:39on a regular continuous basis.
  • 27:42And if they see
  • 27:44a clear winner
  • 27:45in a trial like that,
  • 27:47they have the authority to
  • 27:48stop the trial at that
  • 27:50point.
  • 27:51And
  • 27:52depending on the situation, if
  • 27:53they feel like it's in
  • 27:54the best interests
  • 27:55of the participants,
  • 27:58can then
  • 27:59allow the patients who were
  • 28:01on
  • 28:02the
  • 28:03standard drug
  • 28:04that
  • 28:05turned out not to be
  • 28:08the best one, that the
  • 28:09newer drug was clearly better,
  • 28:11they have the authority to
  • 28:14mandate that the patients who
  • 28:15who were not receiving
  • 28:17the newer drug can then
  • 28:18switch over, we call crossover,
  • 28:20to the newer drug
  • 28:22to get access
  • 28:23to that
  • 28:24superior therapy right away rather
  • 28:26than have to wait for
  • 28:27the drug to get approved
  • 28:28by the FDA.
  • 28:30Doctor Ian Krop is a
  • 28:32professor of internal medicine and
  • 28:33medical oncology at the Yale
  • 28:35School of Medicine, and Alyssa
  • 28:36Gateman is the executive director
  • 28:38of the clinical trials office
  • 28:40at Yale Cancer Center.
  • 28:41If you have questions, the
  • 28:43address is canceranswers
  • 28:44answers at yale dot e
  • 28:45d u, and past editions
  • 28:47of the program are available
  • 28:48in audio and written form
  • 28:49at yale cancer center dot
  • 28:51org. We hope you'll join
  • 28:52us next time to learn
  • 28:53more about the fight against
  • 28:55cancer. Funding for Yale Cancer
  • 28:57Answers is provided by Smilow
  • 28:58Cancer Hospital.