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Many biopharmaceutical companies have discussed how the pandemic has changed clinical trials. However, study sites have also implemented strategies to bring studies into a new realm. In this interview, Aasma Shaukat, MD, MPH, study co-lead, professor of medicine, and director of outcomes research for the Division of Gastroenterology and Hepatology at New York University Langone Health discusses the site perspective.
Moe Alsumidaie: As we come out of the pandemic, can you tell me about your clinical trial design changes over the past two years?
Aasma Shaukat: The pandemic accelerated things we were already trying to do in clinical trial design, including more virtual enrollment, point-of-care enrollment, and ways to reach populations that traditionally don't come to the clinic. Over the past two years, we saw clinical trials pivot to a more virtual enrollment platform. Also, they became more creative in reaching potential participants through social media and engagement channels other than just traditional in-person visits. Here's what a typical example might look like: Say there's a clinical trial available. To find out about the clinical trial, the patient would have to have a visit with a provider like myself, and I would have to remember to discuss the study with the participant and see if they're agreeable. Then a coordinator would call them, and they would come in for a visit. At that point, the coordinator will obtain consent and all the other necessary paperwork. Then the patient would come in again for a blood draw or some other metrics, and they would undergo the procedure or the intervention. Then there would be several follow-up visits in person in the clinic or research space.
The pandemic upended that model. So, the first change was that instead of waiting for patients to come to us to be able to talk about potential studies, we are now reaching out to them. And we're doing that through social media, news outlets, and the internet. So, now, in the comfort of their home, patients can learn what studies they're potentially eligible for and sign up.
Second, consent and education about the study can now be done virtually. So, my coordinators, for instance, pivoted to a Zoom or a virtual enrollment or telephone enrollment visits. Finally, we send mobile phlebotomy to patients instead of them having to come to the clinic to get their blood drawn. We did this very successfully in a trial designed to validate a blood-based screening test that recently completed enrollment, called PREEMPT CRC, which is Freenome's prospective study to validate our blood test for CRC screening among average-risk adults. We sent mobile phlebotomists to participants' homes to draw blood or collect other measurements during enrollment. And all the follow-up was either through virtual visits or by telephone. So that completely changes the paradigm of how studies are done. And it allows us to include a population that otherwise we wouldn't be able to reach out to.
Alsumidaie: I recently read in the New York Times that diversity is still a problem in clinical trials, especially post COVID. Can you tell me a bit about why as an industry, we still have a long way to go toward ensuring that there's sufficient diversity in clinical trials?
Shaukat: That's one of the things that we as a research community still struggle with. There's a lack of diversity in clinical trials. If you think about the standard model of how clinical trials were done, individuals who had access to information about the clinical trials were either connected at large medical centers or through academic centers or perhaps lived nearby. These patients also had the means and the time to participate in these studies, which by those conditions excludes many individuals. When Freenome designed PREEMPT CRC, we wanted to ensure diverse representation and broad reach, so we employed a novel hybrid strategy. First, what was important was going to smaller community networks and clinics. These could be in rural areas, or geographically dispersed locations, and they could also be areas far from academic or urban medical centers. Virtual enrollment allowed us to do that – we have participants from every ZIP code in the continental United States. Second, by using social media, we could reach participants and potential individuals that we otherwise wouldn't necessarily see in a clinic or perhaps in a clinic connected to clinical trials.
The third strategy was to go to practices and places where we know there are a lot of diverse individuals, such as urban neighborhoods—inner-city Chicago and New York City, as well as Florida and Arizona for the older demographic age groups. That was partly strategic and partly a result of a more extensive reach out to these communities. But if you don't do some of those steps, say it's a cancer screening trial, for example, you're limited to relatively sizeable comprehensive cancer centers. And you can imagine that the demographic that goes to those cancer centers isn't representative of the rest of the country. So instead, our PREEMPT CRC trial locations include community hospitals, health systems, private clinics, tertiary centers, and teaching hospitals, allowing our study to represent all patient experiences better.
Alsumidaie: Which of these methods was the most effective way to enroll patients successfully?
Shaukat: There were multiple strategies. One is connecting to smaller networks. We used some of our partners and other resources to figure out where these small practices are that see patients who traditionally don't get a chance, opportunity, or exposure to participate in clinical trials. Second, the ability to offer virtual enrollment helped people who lived further away from a medical center, like longer-distance, drive, and those who didn't have access to easy transportation. This allowed those populations, many of them rural, to participate. So I would say those two were the predominant models that helped achieve this diversity.
The marketing industry has gotten very smart about targeting the demographic that one's looking for. And indeed, receiving an invitation is a good way for people to be exposed to the opportunity as long as it's up to them whether they choose to follow up on it and take up on the offer. So I see that proliferating and increasing with time. And in some ways, that does allow us access to individuals where we could even go a step further, who aren't even plugged into health care who perhaps are a younger demographic—a healthy forty-year-old—and they don't even regularly see a provider.
Alsumidaie: In general, people of color tend to be hesitant and distrust the biopharmaceutical industry and clinical trials, and they won't participate in those trials. Do you agree with this statement?
Shaukat: Traditionally, patients of color do not trust clinical trials. I would say in this study; we found evidence to the contrary. Sites with many patients of color or a sizeable low-income population enrolled more patients than other sites. It depends on the type of study offered if it's a trusted provider, something individuals are enthusiastic about supporting and if it contributes to overall health. Early data indicates that the PREEMPT CRC study populations include approximately 11.3% Black and 10.3% Hispanic. The study showed us that reaching these populations can be done well.
Alsumidaie: Did the healthcare provider, the environment, and the trust between the patient and the healthcare provider make the most significant difference?
Shaukat: It was both the healthcare provider and the study itself. The messaging is extremely important, how providers think the study will contribute to their health and the health of their peers. And how education is put in that messaging regarding what we're asking them to do. Certainly, answering some questions about your demographics and contributing by giving, allowing a blood draw before a scheduled colonoscopy already seemed to resonate with people as a good thing they wanted to participate in.
Alsumidaie: If you had one message or advice for people designing clinical trials and seeking to recruit diverse participants, what would that be?
Shaukat: I would say, think out of the box—don't wait for patients to come and sign up for the study; think of innovative and creative ways to reach out and recruit the kinds of patients you hope that the drug or the study would help them.
Alsumidaie: Anything else concerning protocol design for enrolling a more diverse patient population? Specifically, what made this trial design so acceptable to diversity?
Shaukat: I think it is part of the study in question. First, colon cancer screening is on everybody's radar because it is a significant health issue and a public health issue in the U.S. Second, the screening age was recently lowered to 45. So, that brings in a whole new demographic that we weren't screening before that is probably very curious and engaged in figuring out what is best for their health. And third, I would say multiple avenues and partners. It can't just be one clinic relying on its support network. Still, we expanded our network very widely—some through word of mouth, some through CROs, and others through networks of primary care clinics. So, be as inclusive as possible in bringing in some kinds of patient populations that would be important for this study.