Is Diversity & Inclusion Too Complex of a Challenge to Overcome?

Where are we going and where do we start?

Nobody can say for certain what the regulatory landscape with regards to diversity, equity, and inclusion will look like over the next 5, 10, 15 years. Though, if I had a crystal ball, I would see that the rapid genetic diversification of both the US and globe will make it increasingly challenging for pharma & biotech to demonstrate efficacy of drug candidates. As a result, regulatory agencies will move towards stricter requirements in the name of public safety and under the pressure of legislators, as we have seen with the DIVERSE Trials Act (S.2706) and the Diversity and Equitable Participation in Clinical Trials (DEPICT) Act.

Now, our clinical research industry ecosystem constituents from site to sponsor are looking at the challenge ahead of us and are finding it increasingly difficult to shift from a space of awareness and strategy development and into actionable, measurable, and reproducible plans.

Are You Human?

"Let us not forget that though we can connect on our shared humanity, the unique perspectives of underserved communities must be represented in the workforce that is tasked with the mission of drug development, at all levels."

The reality is, our human existence transcends our work as clinical researchers and is by nature a complex experience. In our global humanity, no one is excluded from experiencing aging, sickness, and eventually death. These are fundamental truths we all have in common, regardless of our race, ethnicity, or socioeconomic status.

Therefore, it is not unreasonable for us to connect on this common ground and set this as the background that frames our collective efforts, no matter where we find ourselves in our ecosystem: at the site, CRO, sponsor, vendor, solutions provider, regulatory authorities, and others. The inclusion and development of diverse talent in the workforce begets the successful inclusion of diverse patients in clinical trials. Let us not forget that though we can connect on our shared humanity, the unique perspectives of underserved communities must be represented in the workforce that is tasked with the mission of drug development, at all levels.

To Risk or Not to Risk

One of the greatest challenges to overcome is the industry's aversion to risk as it relates to engagement of new investigators, diversity and inclusion of de novo sites, and the perception of less-than-perfect standards for drug development & commercialization.?

We are creatures of habit and shy away from the unknown. We stick to our guns when it comes to having overcome previous challenges and staying to the age old, "If it ain't broke, don't fix it!" However, how can we speak about engagement of and opportunities for community-based practitioners and then move at warp speed to acquiesce to client pressures in selecting "preferred" sites? Is there precedent for regulatory authorities to be flexible and engaged with innovative solutions?

Let's look at the example of the advent of decentralized clinical trials (DCTs) amidst the global pandemic. If the FDA and its global counterparts leaned into the innovation and risk associated with DCTs, then why would we expect the regulatory agencies to be punitive and averse in collective efforts to engage, extend opportunities, and support new community-based sites? In fact, we see the FDA publishing guidance documents and being visibly committed to diversity & inclusion. Let's make no mistake - we may be uncomfortable, we may avoid it, but we cannot escape the increasing diversity of our global population as we begin to see race and ethnicity to be far more complex than ever before. This is further compounded as we watch our life expectancy increase, introducing the need for management of more complex conditions and chronic illnesses.

Build Momentum, Compound on Investment

The investment of time, money, and calculated risk-taking for developing a wider investigator reach and driving inclusion of diverse patient populations may not show immediate returns. However, the process of creating and sustaining momentum for our efforts is best described by the concept of the "flywheel effect" by Jim Collins' book, From Good to Great:

"Picture a huge, heavy flywheel—a massive metal disk mounted horizontally on an axle, about 30 feet in diameter, 2 feet thick, and weighing about 5,000 pounds. Now imagine that your task is to get the flywheel rotating on the axle as fast and long as possible. Pushing with great effort, you get the flywheel to inch forward, moving almost imperceptibly at first. You keep pushing and, after two or three hours of persistent effort, you get the flywheel to complete one entire turn. You keep pushing, and the flywheel begins to move a bit faster, and with continued great effort, you move it around a second rotation. You keep pushing in a consistent direction. Three turns ... four ... five ... six ... the flywheel builds up speed ... seven ... eight ... you keep pushing ... nine ... ten ... it builds momentum ... eleven ... twelve ... moving faster with each turn ... twenty ... thirty ... fifty ... a hundred.?Then, at some point—breakthrough! The momentum of the thing kicks in in your favor, hurling the flywheel forward, turn after turn ... whoosh! ... its own heavy weight working for you. You’re pushing no harder than during the first rotation, but the flywheel goes faster and faster. Each turn of the flywheel builds upon work done earlier, compounding your investment of effort."

From Altruism to Commercialization

The bottom line is that we are seeing increasing pressure from regulators, which in turns squeezes an already complex endeavor for pharma and biotech. We know that diversity and inclusion efforts in clinical research have positive impact for health equity. What we do not routinely talk about is diversity from a commercial perspective. Inclusion of representative populations can reduce the risk of efficacy failure in real-world setting which can result in ballooning costs (i.e., class action lawsuits), can widen and prime the prescriber network, and increases the trust that communities place in pharma and drug development industry.

Where DO we start?

How will you on a personal-level begin to push on a micro flywheel from wherever you sit in the broader clinical research ecosystem? When the journey ahead of you seems insurmountable, start with looking at the first step immediately in front of you. Where do you find opportunities to push, despite needing great effort to get the flywheel to budge even an inch?

Here are a few examples to take away:

• At the site-level: look around you. What is the reach of your investigator in terms of patient referrals? Build a referral bridge from community-based practices and distribute patient recruitment education to these physicians/clinicians. Ask your investigators to initiate and open up those channels of communication. Then, ask those providers to tell you what their patients' needs are: do they speak other languages? Are there transportation barriers? What do their communities need to even be able to consider participating in your studies?
• At the CRO-level: Offer the highest value for your clients. Sometimes, this means pushing back on client expectations to deliberately create space for mindful strategic feasibility, site identification, and site selection. Are there sites from within the community that can be looked at differently and beyond the approved feasibility questionnaires? Educate the client on the needs for Diversity Plans and offer support via advocating for smaller sites. Shift your perspective on historical negatives around site networks and the perception of the "mill" sites. Challenge your biases and perceptions of community-based sites not being capable of producing quality work. Push on the clients to invest in sites equitably - move away from "fair market value" when we know that the market is not fair for sites to begin with.
• At the sponsor-level: Have you solicited the input of representative patient focus groups to advise on your protocol design? Engage your sites early and solicit feedback from site study coordinators on the feasibility of the protocol at the earliest phase of protocol development - it will save you on costs associated with future protocol amendments! Set expectations for and hold your CRO and vendors accountable to diversity & inclusion efforts. Include the development of actionable Diversity Plans as part of your requests for proposals and prioritize this as a capability with executive leadership - doing so will, over time, can impact positively as shareholders! Recognize that investing early can mean less post-market approval requirements and overall cost savings that may be invisible at the moment.