Increasing Access to Clinical Trials

Transcript

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

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Increasing Access to Clinical Trials with guests Dr. Ian Krop and Alyssa Gateman, January 12, 2025

Yale Cancer Center

visit: http://www.yalecancercenter.org

email: canceranswers@yale.edu

call: 203-785-4095

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Guests

Dr. Ian Krop and Alyssa Gateman

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