Increasing Access to Clinical Trials
January 13, 2025ID12617
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- 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.