Rapid Case Ascertainment Shared Resource

Transcript

• 00:00Hi, everybody. I am Raj
• 00:02Nimehta. I'm the director of
• 00:04the rapid case ascertainment
• 00:06shared resource.
• 00:08And
• 00:09next slide, please.
• 00:11So
• 00:12the rapid case ascertainment resource
• 00:14is a little different from
• 00:16probably what you've heard,
• 00:17because we we work with
• 00:20investigators conducting
• 00:21non therapeutic studies. So you
• 00:23can think of us as
• 00:25you can think of the
• 00:26clinical trials office as the
• 00:28therapeutic,
• 00:30resource,
• 00:31and we are the non
• 00:32therapeutic. So we support,
• 00:35cancer center members
• 00:37in,
• 00:38in studies that are non
• 00:39therapeutic for case identification,
• 00:42study management, patient enrollment, medical
• 00:45record abstraction,
• 00:47and specimen collection so they
• 00:49can accomplish their scientific goals.
• 00:52Next slide.
• 00:55So we have been a
• 00:57YCC shared resource since nineteen
• 00:59ninety five,
• 01:01and we wear several different
• 01:03hats. Right? So we we
• 01:05work as Yale staff to
• 01:07support Yale studies, but we
• 01:09also work,
• 01:12as agents of the Connecticut
• 01:13Tumor Registry through a personal
• 01:15service agreement
• 01:17so we can collect data
• 01:18from
• 01:19outside
• 01:20hospitals that are not Yale.
• 01:22So that's kind of our
• 01:23Connecticut Tumor Registry hat.
• 01:26So in in this personal
• 01:28service agreement, after we get
• 01:30all the approvals,
• 01:31we can assist investigators
• 01:34in identifying cases and collecting
• 01:36specimens from,
• 01:39Connecticut hospitals for our for
• 01:41through the Connecticut Tumor Registry.
• 01:45The cost of RCA
• 01:47is is really the staff
• 01:49time and effort. Right? We
• 01:51we don't have any machines
• 01:53or we don't have any
• 01:54equipment. We just charge
• 01:56for our time and effort
• 01:59devoted
• 02:00to what we do for
• 02:01each investigator,
• 02:02and we do that in
• 02:03two ways. So we have
• 02:04our current,
• 02:07way of one hundred and
• 02:08forty dollars an hour, and
• 02:09that's a fee for service.
• 02:11And as a cancer center
• 02:12member,
• 02:13you get, a fifteen percent,
• 02:15discount
• 02:16on that. So it's a
• 02:17the cancer center pays fifteen
• 02:19percent of that. So you're
• 02:20only charged for the eighty,
• 02:23eighty five percent.
• 02:25And then another way that
• 02:27we recover costs is that
• 02:30some of our staff are
• 02:31dedicated
• 02:32to your study
• 02:34as a percent effort. So
• 02:36many studies
• 02:37cannot,
• 02:38hire a full time person.
• 02:40So if you can hire
• 02:41your full time person, great.
• 02:43You can go and hire
• 02:44them. But many
• 02:45of our studies are smaller,
• 02:47and investigators
• 02:48only have, like, let's say,
• 02:49a twenty percent effort or
• 02:50a ten percent effort. So
• 02:52that's where we can come
• 02:53in,
• 02:54and you can hire somebody
• 02:56at that
• 02:57small effort to help you,
• 02:59and you don't have to
• 03:00hire somebody because you could
• 03:02never,
• 03:03hire somebody at that, level
• 03:05of effort. So that's how,
• 03:07some of our staff, you
• 03:08know, work twenty percent on
• 03:10one study, twenty percent on
• 03:11another study. So so it
• 03:12really helps these smaller
• 03:14investigators who do not have
• 03:16a lot of money,
• 03:17be able to conduct their
• 03:19studies. Because if if, of
• 03:21course, if you have a
• 03:22full time FTE, then it's
• 03:23great. You have somebody dedicated,
• 03:25but we can help you
• 03:26in that way.
• 03:29In in addition to the
• 03:31dedicated effort, just being able
• 03:32to charge you by the
• 03:33hour is something that some
• 03:35investigators like because you don't
• 03:37you only need a certain,
• 03:39let's say, hundred records extracted.
• 03:41Right? So we just say,
• 03:42okay. Can you extract a
• 03:44hundred records for us? We
• 03:45don't
• 03:46it could take us, you
• 03:47know, a couple of months,
• 03:48but we just pay you
• 03:50by the hour that we
• 03:51work on your study.
• 03:53So those are the the
• 03:54two different ways.
• 03:55Next slide.
• 03:57And so, again, these are
• 03:58our key services
• 04:00that we perform. We have
• 04:01a lot of experience with
• 04:03IRB approvals,
• 04:05overall study management.
• 04:07You know, people come to
• 04:08me to say, oh, how
• 04:09do I get this DUA
• 04:10done?
• 04:12Can you help me?
• 04:13How do I pay sites?
• 04:15Can you help me pay
• 04:16sites? And and so these
• 04:17are just,
• 04:18staff,
• 04:19you know, activities that that
• 04:21people need help with. We
• 04:23identify
• 04:24cancer cases. So if you
• 04:26say
• 04:27you need to identify everybody
• 04:29with liver cancer because you
• 04:30wanna do a study,
• 04:32and abstract treatment on liver
• 04:34cancer, so we can help
• 04:36you with that.
• 04:37Again, extracting medical records. Many
• 04:39of our,
• 04:42you know, the IRB protocols
• 04:43require physician consent. So we
• 04:46help investigators
• 04:47identify the patients and then
• 04:48contacting these the their their
• 04:51clinicians for permission to contact
• 04:53them. We screen them. We
• 04:55conduct surveys either in person
• 04:57or,
• 04:58sending them a link. We
• 05:00also collect
• 05:02blood,
• 05:03specimens during their standard of
• 05:05care collection. Some some
• 05:07investigators,
• 05:10wanna collect an additional tube
• 05:11of blood
• 05:12from these, patients that are
• 05:14getting certain treatments
• 05:16or,
• 05:17you know, the COVID vaccine.
• 05:19They wanna test, you know,
• 05:21markers, and so we have
• 05:23done that as well.
• 05:25Same thing for stool and
• 05:26CSF.
• 05:27And we also work with
• 05:29archival pathology specimens.
• 05:32We work with Yale New
• 05:34Haven Hospital with,
• 05:35the shared resource also, and
• 05:38we work collecting specimens from
• 05:40all over the country.
• 05:43Cohorts, for example, everybody who's
• 05:45who has,
• 05:46had, like,
• 05:48liver cancer,
• 05:49through the VA, for example.
• 05:51We've done a study where
• 05:53we collected from all the
• 05:54stations at the VA for
• 05:56patients who had liver cancer.
• 05:58And then it was brought
• 05:59you know, they shipped the
• 06:00specimens. We we worked with
• 06:02the l pathology
• 06:03to section them with our
• 06:04study pathologist,
• 06:06and then we returned these
• 06:07specimens.
• 06:09We also serve as honest
• 06:11brokers, which means that some
• 06:13studies that the investigator has
• 06:15to be blinded.
• 06:16We're able to be that
• 06:18person who that the the
• 06:20the shared resource who knows
• 06:21who these patients are to
• 06:23be able to collect the
• 06:24specimens. But when
• 06:26we give it to the
• 06:26investigator, it's de identified.
• 06:29So the IRBs will usually,
• 06:32exempt those studies because you're
• 06:34not collecting any identifiers.
• 06:36You you we are your
• 06:38middle person, your honest broker
• 06:40to know.
• 06:41We know who they are
• 06:42to collect the data, but
• 06:43you are not getting anything.
• 06:45And, again, some of the
• 06:46other things that we've done
• 06:48is collecting films,
• 06:49radiology scans. So we work
• 06:51with investigators.
• 06:53If they wanna collect anything,
• 06:55we we can help you
• 06:57and and kinda brainstorm how
• 06:58to do this.
• 06:59Next slide.
• 07:01So this is just a
• 07:03really quick example of the
• 07:05studies that we've done.
• 07:08So prospective identification
• 07:10with surveys and pathology collections.
• 07:12These, again, newly diagnosed.
• 07:15We do you know, I've
• 07:17talked a little bit about
• 07:18this where we can,
• 07:20we can consent the patient.
• 07:22We can collect,
• 07:23some a survey. We can
• 07:25collect their specimens.
• 07:28We do this, again, also
• 07:29retrospectively.
• 07:30Like, there's a a retrospective
• 07:32cohort of ten years of,
• 07:34let's say,
• 07:36brain tumors,
• 07:38and we can go back
• 07:39and do a whole medical
• 07:40record abstraction, collect their slide
• 07:42their blocks,
• 07:44collect imaging, everything.
• 07:47Number three is, again, our
• 07:48our work with our connect
• 07:50with the Connecticut Tumor Registry.
• 07:51This is like our our
• 07:53kinda Connecticut Tumor Registry hat
• 07:55a little bit differently than
• 07:56as working as a Yale
• 07:58employee.
• 08:00And we we can collect,
• 08:02specimens, medical record abstraction
• 08:06for,
• 08:07any, you know, any patient
• 08:09diagnosed in Connecticut.
• 08:11As you know,
• 08:12any cancer diagnosis is reportable
• 08:15to the Connecticut Tumor Registry,
• 08:16so they
• 08:18have everybody who's been diagnosed
• 08:20with cancer. It's the oldest,
• 08:22tumor registry in the country.
• 08:25And then, again, our, like
• 08:27I've said before, we also
• 08:28can collect,
• 08:30blood, stools. We've done some
• 08:31of these,
• 08:33CSF collections that investigators need.
• 08:35We we bring the tubes,
• 08:37and then when they're getting
• 08:38their CSF or their biopsy,
• 08:40we then,
• 08:41transport that back to the
• 08:43lab that's gonna be,
• 08:46analyzing that.
• 08:48Next slide.
• 08:51So just I've touched a
• 08:52little bit about this, but
• 08:53the benefits
• 08:54is that we we have
• 08:57a lot of experience.
• 08:59I've been this I've been
• 09:00doing this for twenty five
• 09:01years in this position. We
• 09:03have Rocco who's been here
• 09:04for thirty five years, forty
• 09:06years.
• 09:08So we we've have a
• 09:10lot of experience in in
• 09:12lab experience
• 09:13and IRB experience. We're very
• 09:15flexible.
• 09:17I usually meet with every
• 09:19investigator that wants to use
• 09:21RCA just to kinda guide
• 09:22them. You don't have to
• 09:23use me. A lot of
• 09:24times, they're like, oh, thank
• 09:25you for letting me know
• 09:26I could do this. So
• 09:27I'm here just for to
• 09:29also provide guidance,
• 09:30through study planning,
• 09:33just to give you just,
• 09:35ideas and how to better
• 09:37do your study. If you
• 09:38don't have any funding, I've
• 09:39still I can still help
• 09:40you. You know, I'm happy
• 09:41to meet with anybody
• 09:43just to guide you on
• 09:44what you need to do.
• 09:45I do this all the
• 09:46time. How do I apply
• 09:47for IRB?
• 09:49So I'm here to, you
• 09:50know, support anybody here at
• 09:52the cancer center.
• 09:54Next slide.
• 09:56So here's my email.
• 09:58Please feel free to reach
• 09:59out,
• 10:01and I can, you know,
• 10:02try to help you in
• 10:03any way I can.