Leveraging Digital Technology to Increase Diversity in Clinical Trials

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Leveraging Digital Technology to Increase Diversity in Clinical Trials:

An Interview with Scott Treiber, Vice President, Strategic Development at Synteract

Scott Treiber, PhD, MBA, is Vice President, Strategic Development at Synteract, and an industry veteran with experience at many of the top global CROs, as well as a board member at the Center for Healthcare Innovation. His conversation with Medable is summarized below.

COVID-19 has undoubtedly brought awareness to the issue of diversity in clinical trials, but should it have taken a global pandemic to make people aware of this issue?

People in the industry have been aware of the lack of diversity issue, but some have chosen to ignore it or brush it aside. The biggest problem, in my opinion, is that there have been no penalties for not achieving higher diversity figures in clinical trials, and only minor financial repercussions to pharma/biotech companies when their treatments either do not work across all groups once approved, or there is a lack of uptake by all groups due to the lack of testing in those groups. It is clear that the lack of clinical trial diversity has adversely impacted the reputation of the industry and the ability to recruit diverse populations in the future.

The FDA has developed a strategy to address diversity in the clinical trial process. Do you think it goes far enough?

Overall, it’s a good start, and it will hopefully evolve over time with input, examples, and suggestions from the industry. I actually reviewed this guidance in a webinar on diversity where I go into greater detail.

Equally important as this guidance, though, is that the FDA needs to start enforcing the diversity requirements in later trials. I know the counter argument is that this will require longer enrollment periods, which means treatments will take longer to get to market, but the reality is that the lack of diversity in the current system is leaving people behind.

How do you think diversity in clinical trials plays into different therapeutic areas, and do you feel there needs to be a different strategy for each TA or indication?

I think we can get as specific as individual indications. We need to be looking at the incidence of disease and affliction by race, ethnicity, and gender when we begin laying out clinical development programs. In terms of strategies for each indication/TA, there are nuances to recruitment strategies with each, but we have a much broader issue of trust and reputation that needs to be bridged if we ever want to achieve the parity that is a moral imperative here.

What role do you feel technology companies such as Medable have to play in terms of improving diversity, equity, and inclusion (DE&I) in clinical trials?

Technology has a role in improving clinical trial diversity on several fronts. First, the use of data analytics has improved our ability to find the right patients for trials, including finding a more diverse trial population. Second, the broad array of technology tools – telemedicine, ePROs, eCOA, etc – has made it easier for some patients to participate in trials.

One thing that technology companies, like Medable, as well as sponsors, CROs, etc need to pay close attention to, however, is that while these new technologies make it easier for some patients to participate—like those that are further away from clinical trial sites, have mobility issues, etc—there are still many potential patients that don’t have access to mobile phones, computers, or internet connections.

When it comes to decentralized clinical trial technologies to help address diversity, do you think there is one critical technology component?

As with so many other things in life, there is no easy answer or single approach that will solve this problem. It’s going to take a combined approach of technology, improving access to clinical trial sites, patient concierge services, home health nurses, and building trust through patient advocacy and community services/groups to move the needle further.

Patient advocacy councils and groups build relationships and increase trust with different patient populations, especially underserved groups. What’s the best way to capture the patient voice when designing clinical trials, and how does that play into more successful recruitment strategies for diversity?

Building trust is imperative, and I know that Medable is working on this angle through their patient advocacy and site relationship efforts. Many of the larger pharma/biotech companies do engage patient advocacy groups and set up patient panels to get feedback on clinical trial design, but some of the smaller companies aren’t always able to do this. It’s incumbent on CROs to push these smaller/midsize companies to consider engaging patients earlier on in the development process. I do believe that if these patient panels are constituted with a diverse cross section of the population with the disease/indication, much can be learned about how to address the recruitment of these groups for trials.

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