Expanding diversity and inclusivity in clinical research is an increasingly important objective for life sciences research teams. As we look back in history, we can see that most clinical trials have too often failed to represent the diversity of target populations they are being designed to serve.
Mednet is a proud member of the Medical Alley Association, an organization that supports and advance the global leadership of Medical Alley’s healthcare industry and its connectivity around the world. Their recent webinar, Helping Close the Health Inequality Gap Through Inclusive Clinical Trials, brought together panel members from several healthcare, research, and academic organizations to discuss the challenges of creating diversity in clinical trials and share insights from their continuing efforts.
The panel agreed that inclusion requires an intentional approach and investment in relationships across underserved communities where racial inequities are ongoing. The current pandemic has magnified healthcare disparities. Severe illness rates have increased because of common environmental risks such as frontline jobs and multi-generational housing. These higher disease rates disproportionately impact minorities who might otherwise participate in a trial.
A key concern is the systemic nature of the challenges and how they spread into all aspects of a trial – from inherent bias in trial design, to the lack of infrastructure supporting trial participants. The presenters described numerous scenarios where basic logistics negatively impacted participation. As an example, trial participants may not have transportation or money for out-of-pocket costs required to get to and from a trial site for observation. Important details like these can impact who can or will participate in clinical trials.
In November 2020, the U.S. FDA published their most recent guidance on the topic: Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs. The guidance suggests ways to expand clinical trial eligibility criteria with inclusive trial practices and designs. It also describes how sponsors can increase enrollment of underrepresented populations in clinical trials.
The guidance echoes some of the same concerns voiced by the Medical Alley webinar panel, noting,
“Sponsors should enroll participants who reflect the characteristics of clinically relevant populations with regard to age, sex, race, and ethnicity. Inadequate participation and/or data analyses from clinically relevant populations can lead to insufficient information pertaining to medical product safety and effectiveness for product labeling.”
The FDA piece also suggests inclusive trial practices and trial designs. Innovative designs such as adaptive trials may support greater diversity. An adaptive design trial could start with a narrow population. Based on interim safety data, it could then expand to a broader population. In addition, broadening eligibility criteria and improving recruiting practices, so participants reflect the population most likely to use a drug are key themes of the guidance.
The Medical Alley webinar panel’s discussion and the recommendations outlined in the FDA guidance seem to align in many ways. Both acknowledge the work that has been done toward greater diversity. Both also recognize the gap that still exists and the vast opportunity for improvement.
Many sponsors are already working with patient advocates, local hospitals, community leaders, academia, and other private/public partnerships to address diversity in clinical trials. Their efforts also engage internal research teams and are changing the way trials are planned, designed, and conducted. The industry’s push toward virtual trials is also a key component of attracting and engaging a more diverse population.
The sweeping change required for greater diversity and inclusion in clinical research demands an innovative mindset, openness to new approaches, and operational flexibility. At Mednet, we are already leading the way. Our flexible platform supports mid-trial modifications, such as expanding participants, and helps teams respond quickly and efficiently. This level of flexibility enables adaptive design trials and positions sponsor teams to develop new operating procedures that meet the moment. Our novel ePRO capabilities render on any browser. This essential functionality broadens access for trial participants through a wide range of devices. These are two small examples of how the Mednet product strategy aligns with the emerging needs of the industry.
We understand that many challenges remain. We are committed to working with our customers, partners, and other stakeholders to overcome any obstacles. Today and tomorrow, Mednet’s solutions offer the flexibility and functionality required to drive diversity, inclusion, and equity in clinical trials. For more information, contact us.