What are the ramifications from a clinical research perspective if diversity is not appropriately represented in a clinical study populations? Even as diversity becomes increasingly important across different sectors, minorities continue to be left out of clinical trials and medical research studies. So, why is diversity so critical in clinical trials?

Nik explains, "I think in terms of the ramifications if diversity is not appropriately represented — I think we, unfortunately, saw this clearly playing out during the pandemic when we were seeing a lot of the data emerging that many underrepresented patients, particularly black and Hispanic patients, were having worse outcomes with COVID. Yet when we were looking at a lot of the trials for vaccines and therapeutics, those patients were not being included in the studies. And then as a result, from a scientific standpoint, when the results of the studies came out, people were understandably questioning, ‘Are these results that we're seeing generalizable to all the patients with the disease and especially the patients who're having the worst outcomes?’"

Recruiting and enrolling more representative populations does not mean delaying the study. Despite what many people think, enrolling diverse populations in clinical trials won't slow down the process. Nik shares his experience with including underrepresented minorities in peri- and post-approval studies through decentralized clinical trial models.

He says, "The great thing was that not only did we complete that study and we had the data and that really gave us a lot more confidence in our medicine but also that trial recruited in record time, which was one of the myths that people had been saying, 'Oh, we could have a more diverse trial population, but it's going to slow the study, and we don't want to do that.' So, this study, we had 84% from underrepresented populations and actually was one of the fastest studies that Genentech ever enrolled and was published in the New England Journal of Medicine."

Clinical trials must strive to be more diverse. Enhancing diversity in clinical trials is a win-win for the entire public health system, not just for underrepresented populations. Nik explains, "We're thinking about this very carefully at Genentech, and we're trying to make sure that our efforts in terms of improving diversity in clinical trials is not just a one-off thing, that we really make this part of just the routine way that we do every clinical trial."

He adds, "I think our vision, as I mentioned, is that we really need to make enrolling a diverse and representative population a routine part of how we conduct all of our trials, which will not only increase the robustness of our research, but it will also help ensure broad patient access, and as we've seen from a few studies, not only will it not slow down studies but if done right can even accelerate trials. If we can do all of that, that can really represent a true win-win for patients, for us as a company, and for society as a whole."

We must really embrace and prioritize diversity in clinical trials by understanding and addressing the underlying barriers to participation in clinical studies. One opportunity to do this is through decentralized clinical trials.

Nik says, “decentralized clinical trials or DCTs … there's sort of a lot of buzz about this term right now. But, but at its core, it's really very simply just about essentially democratizing clinical research and improving the patient experience by meeting patients where they are…” “….from a clinical research perspective, I mean, our approach to decentralized trials is really to take kind of a patient first approach to think about… how a decentralized trial might help to improve either quality, speed, cost or the patient experience.”

"I think one thing we did find where there was agreement between both healthcare providers and patients was that a positive, trusting relationship with a patient's healthcare provider is one of the key factors in terms of building trust in the system overall, and we're finding the same thing in our clinical studies," Nik says. "So, the trusting relationship between the investigator and the participant is super important in terms of patients wanting to be part of clinical research."

"We're really starting with making sure we have a good understanding of the epidemiology and the disease," Nik commented. "We're really looking very closely at our site selection to include both community-based and urban-centered sites that have access to large, underrepresented populations. But then beyond that, I think we're also really trying to make sure we recruit investigators who have experience in enrolling underrepresented patients into clinical research and also a passion for health equity research because that passion comes through in how they present the trial to patients and in their ability to build trust with their communities. And then finally, we're trying to also break down any logistic barriers that may be hindering patients from being able to participate in research."