Ariel Katz, CEO and cofounder of H1.
In part 1, I discussed why federal intervention is necessary to enforce diversity throughout the pharmaceutical lifecycle, especially in clinical trials. In part 2, I will discuss the main roadblock hindering diversity goals and how pharmaceutical companies can overcome it, plus what I believe the future holds for advancing equity in healthcare.
Clinical trials are a crucial step in bringing new treatments and therapies to patients, but the lack of diversity in trials—which leads to incomplete data and limits the generalizability of results—often delays or derails the process. Legislation can help address diversity gaps in healthcare research by creating legal requirements and establishing penalties for non-compliance. The U.S. government has already taken steps with its recent guidance and omnibus bill, which will require diversity action plans for any clinical trials presented to the FDA for late-stage approval.
But pharmaceutical companies mustn’t wait for government guidance to become law to transform their clinical trial processes. Developing a successful diversity plan requires time and planning. Two critical elements of a successful diversity plan are: (1) Specifying the goals for enrollment for underrepresented ethnic and racial participants, and (2) detailing a specific plan of action to engage and enroll diverse participants.
Recruitment of diverse patients is, without a doubt, the biggest obstacle hindering clinical trial diversity. The clinical trial recruitment process has always been painful, long before DEI was a factor. Adding these requirements makes it even more difficult.
Overcoming Recruitment Challenges
There are four key factors that impact the ability to successfully recruit diverse patients for trials. My company refers to these as the “ABCDs”: awareness, burden, confidence and disqualification.
To start, many minority groups are not even aware of clinical trial opportunities. Patients might be willing to participate but have no idea how or where to turn for information. This can be solved through communication and education within the community.
Then there is the burden of participating in trials, including taking unpaid time off, travel and caregiver commitments. Pharmaceutical companies can offer ways to make it easier for patients to access trial sites and participate, whether it’s a hybrid approach, reevaluating site locations or offering stronger financial reimbursements. Conducting trials within underserved communities—or at non-traditional sites such as community health centers and pharmacies—can help relieve some of this burden.
All patients, but especially minorities, have a general lack of confidence in the pharmaceutical industry. The way Covid-19 was handled by pharma companies certainly did not help. Seen as untrustworthy, money-hungry corporations that don’t really care about the humans at the end of the Rx bottle, this is a tough reputation to overcome. Being transparent with patients about the process and taking authentic steps to be inclusive can build trust back. Pharmaceutical companies should make connections with community leaders, employ diverse investigators and staff who reflect the communities they are serving, and invest in underserved communities on an ongoing basis—whether through public health education programs or giving back in other ways.
Finally, in many cases, minority patients are unintentionally disqualified from clinical trials due to stringent inclusion and exclusion criteria of the trial design. Meant to measure the effect of the treatment on “the ideal patient,” disqualification often occurs due to comorbidities and potential drug interactions. This is a big reason why sometimes, despite a company’s best efforts, diverse patients still aren’t being reflected in trial results. Pharmaceutical companies can take steps to improve criteria and minimize disqualification as part of their diversity planning.
If the pharmaceutical industry can be more aware of these factors impeding clinical trial recruitment and participation, then they can transform the process to make it more inclusive.
Three Things The Future Holds
The pharmaceutical industry needs to put diversity at the center of everything it does. And, to be truly equitable, it needs to be tackled on a global level. I predict that the following three factors will fuel a massive transformation in clinical trial diversity over the next three to five years:
1. A period of learning as more drugs are denied and consequences are understood: We are already seeing the FDA reject drug approvals due to a lack of diversity in trials. As the omnibus bill becomes law, we’ll no doubt see more. We’ll learn about what makes a good diversity plan, what happens when a plan is successful and, perhaps more importantly, what happens if a plan is unsuccessful. And notably, the industry will have open conversations and collaborations about these learnings to support improvement as a whole.
2. Technology will accelerate faster than you can say “clinical tri…”: Technology is already moving at a break-neck pace, and it isn’t slowing down any time soon. With the rise of AI and advanced data science, tech will accelerate at such a pace that it will help us in ways we can’t even imagine. But one thing we know is that new technologies will enable pharmaceutical companies to get their medications and treatments to all patients faster, safer, smarter and more equitably.
3. Big data will play an integral role in fueling global trial diversity: The evolution of how we collect and analyze clinical trial and patient data will influence the future of representation. The U.S. might be an early adopter, but we’ll soon see how different countries adopt new clinical trial strategies. This collective data will yield insights that will continuously improve the process. For example, pharmaceutical clinical feasibility teams can tap into granular diversity data beyond patient demographics and down to the indication and disease level to uncover diversity gaps in current clinical trials and make the process more representative.
While ensuring diversity throughout the drug lifecycle—from clinical trial design to commercial launches—is the goal, the reality of achieving it is complex. Federal intervention requiring the recruitment of diverse patients in clinical trials is the right move. This is a huge step forward and, by leveraging the right data and collaborating, pharma can have a great impact on the future of global health equity.
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