Clinical trials play an essential role in achieving positive health outcomes for patients of every race, gender, sex, age, geography and socioeconomic status. With that realization, a growing number of biopharmaceutical companies are seeking to conduct more diverse and representative trials that ensure treatments address real-world patient needs.
But what does diversity in clinical trials really mean? And how can a deeper understanding of diversity translate into trials with better representation?
Dr. Eddilisa Martin, owner and CEO of 2M Clinical, weighed in on misconceptions about clinical trial diversity and how we can better expand our view.
“Often when people talk about diversity in clinical trials, they are referring to underrepresentation of African Americans or Hispanics, but there are many other facets to diversity in addition to race and ethnicity,” said Dr. Martin. “You want to think about other things like diversity in geography, socioeconomic status, comorbidities and age.”
Geographic diversity is one important factor to consider. Zooming out we see study sites usually concentrated on the East Coast, California and Texas with most of those aggregated around large academic medical centers. We need to continue to explore methods to have more community-based facilities and practitioners involved in clinical trials so that patients accessing care in the facilities are involved in clinical trials too. That may involve recruiting patients who live farther from testing sites, decentralizing clinical trials, and being open to new or nontraditional study sites.
Socioeconomic diversity is another factor that is often overlooked. Clinical trials sometimes unintentionally exclude certain populations simply due to the logistical constraints necessary to participate. For example, a potential participant may live and work far from where a clinical trial site is located; typically in more urban areas or center cities. Trial participation can often require significant travel and taking time off from work. For an hourly worker without paid-time off, that may mean lost wages. Ultimately, an individual in this situation could decide participating is not worth it, even if the desire is there. Making sure certain socioeconomic populations are represented means helping overcome logistical obstacles they may face.
A third diversity consideration involves comorbidities and varying stages of illnesses. In clinical trials, it’s important to isolate variables so scientists can properly study the effects of the treatment or drug they’re developing. However, if potential patients are being excluded due to the presence of other illnesses, it could end up excluding populations with a widespread prevalence of that illness. To that end, the study may not reflect how the drug or treatment will affect a population containing those comorbidities or ranges of severity down the road. As Dr. Martin explains it, “You need people with a wide array of other comorbidities that really represent a real-world population and not an ivory tower, non-representative population.”
Sponsors who want to increase diversity must realistically balance pressure for trials to be expeditious, from enrollment to submitting paperwork to the FDA for approval. Another trend clinical trials encounter today is pressure from multiple sources to collect much higher volumes of data, according to a 2021 study by the Tufts Center for the Study of Drug Development. The study found that Phase III clinical trials now generate an average of 3.6 million data points, triple the amount of data that late-stage trials collected a decade ago.
The good news? Increasing diversity while meeting these demands is not impossible. Sponsors have access to technology, experts and resources today that create unprecedented possibilities.
From the start, patient populations can be more thoughtfully selected as abundant data is vetted in advance. By putting in that work up front, sponsors can avoid costly obstacles down the road from a trial’s lack of diversity. Decentralized Clinical Trials (DCTs) create opportunities for remote participation like never before. Telehealth and technology in patient care and monitoring can also foster a more geographically diverse participant group. For in-person trials, sponsors can increase geographic and socioeconomic diversity by providing transportation and stipends to patients who may not otherwise have been able to participate.
These are just a few of the ways sponsors can design and conduct smarter clinical trials with better representation. Consultants like 2M Clinical who are familiar with the goals and constraints of clinical trials suggest that biopharmaceutical companies engage in these considerations early, prior to clinical trial protocols being finalized. 2M Clinical is focused on providing strategic considerations upfront, in order to ensure studies are realistic for patients and appropriately representative. It is important to design clinical trials that not overly burdensome for participants, while also considering geography and non-traditional research sites as avenues to provide access to more representative populations.
Dr. Martin recommends that sponsors engage consultants at the beginning of designing clinical trials rather than when they’re already underway. This way, they can ensure the patient perspective is top-of-mind from start to finish. She shared how sponsors often engage her team when their protocol already has been designed and they’re having problems recruiting patients near study sites that meet their inclusion criteria. Developing more informed protocol can help prevent these issues and enable trials to achieve better results for everyone involved—most importantly, for patients.