W2O Digital Health Summit Panel Summary: Clinical Trial Diversity in Recruitment/Identification

How do we understand the impact of drugs on diverse populations when their participation in trials is under-represented?

Under-representation suggests not only a systemic industry problem, but (it) begs a larger and more important question – Are new medications effective and viable for everyone in the affected population? To ensure they are, the racial, ethnic, age and gender composition and makeup of individuals enrolled in clinical trials that lead to drug approvals must be comparable to that of the overall affected population.

In a strikingly candid discussion, three health sciences titans, Sonali Duggal of Par80, Jackie Kent of Medidata, and Peyton Howell of Parexel, shared their points of view and opinions during the 2021 W2O Digital Health Virtual Summit: Clinical Trial Diversity in Recruitment /Identification.

Trust, Access, Design, Patient Burden, Bias and Speed, or the lack thereof, were chief among the challenges the group identified as integral to addressing this important topic.

I encourage you to spend 30 minutes watching this panel discussion. Like me, you will be inspired, informed and emboldened by the insights and powerful thought leadership of these three thought leaders. Below are highlights from the conversation.

ENGAGEMENT: “Start Here” – A Paradigm Shift that Builds Education and Awareness

Sonali Duggal shared a perspective that represents a crucial path forward – participation and involvement of both the patient population and community health centers.

“We have to engage with communities and health centers sooner rather than later. Not only will you increase diversity, but the chances of getting diverse patients to participate to actually ultimately enroll in trials is much higher. If they (patients) have been brought along the process, you’re building that education and awareness from day one.”

FDA GUIDELINES: “The Impact on Industry” – Trend or A New Standard?

Peyton Howell views non-binary guidelines as encouragement and an opportunity to move the industry forward:

“As part of working with sponsors, we’re bringing these issues forward to the table, but we’re also excited to really see a different energy on this issue (Clinical Trial Diversity)…commitment from sponsors across the board…both large pharma companies as well as smaller biotech and emerging companies. That is different! The guidance is simple and straightforward; so to me, it’s been a good foundation. It opens the door for broadening those eligibility criteria and it has quite a bit of room for focusing on issues of patient burden…So I think it’s showing the intent from the FDA…We needed this kind of encouragement so that we can make this part of the foundation to really bring us forward.”

IT ISN’T DATA ALONE: “Seek the Source and Try Something Different”

Too often, we rely on a method or way of doing things because “that is the way it has always been done.” Jackie Kent suggests we “build on” what we do by bringing key participants and partners to the table:

“It’s not just about using the data that’s available to us to understand how to design trials different…It’s really getting to the actual sites and academic centers and the people that are running the trials and also discussing those trial designs with them. We have to bring the people actually executing to the table and partnering.”

I wholeheartedly concur with Jackie’s assessment. After all, the definition of insanity is doing the same thing over and over again and expecting a different result. To that point, Sonali added yet another perspective that further focuses on the power of doing things differently:

“One of the things that they (FDA) wrote about that really struck me is that we will see an attempt to go beyond academic medical centers as a source for recruiting patients. It’s clear that we can’t be going back to the same patients over and over.”

TAKE ACTION: All Steps Matter

Finally, Jackie’s perspective on the future of Clinical Trial Diversity is a call to action, encouraging each of us to do our part to not only bring about change, but to lead through action:

“Covid made it very clear with the data that was front and center that this (Diversity) isn’t a maybe to do, a might do…It’s not a problem that needs to be defined anymore. It’s all about taking action. If you’re a small biotech, take a small step. If you’re a major pharma, take a big step…make a big commitment…really put action in your 2021 plans to really make a difference. All steps matter.”

This Summit was an inspirational opportunity to share thought leadership. It also brought to mind the wise words of another health sciences thought leader, Dr. Aletha Maybank, the American Medical Association’s Chief Equity Officer and Group Vice-President:

“With any relationship, you build it. Folks doing work from leading institutions have asked, ‘How do we build trust?’ Well, it’s not rocket science. It’s about building relationships. Are you getting to know me beforehand? Are you speaking in a language I understand? Are the concepts broken down so that they are digestible? Are you present? Are you giving resources to our neighborhoods beforehand? That’s not rocket science. It’s building a relationship. That’s how you build trust. And trust is a fundamental value in humans. There’s no rocket science behind it.”

Eric C. Roberts
Hū, VP Trial Diversity & Inclusion