Aman Khera, Global Head of Regulatory Strategy, provides an assessment of the clinical research industry’s performance with respect to diversity and inclusion.
We tend to approach the end of any year with a view toward self-improvement. As an industry, we are in a moment when diversity and inclusion present opportunity for self-evaluation. Last year, the FDA reported that 72% of clinical trial participants were White. With respect to age, only 26% of clinical trial participants were 65 years of age or older.[i] The FDA has released a final guidance aimed at enhancing diversity in clinical trial participants, advising broadened eligibility criteria, adaptive trial models, and increased awareness of barriers to participation.[ii]
As we approach the close of 2020, I’d like to provide this snapshot of where we, as an industry, stand in our efforts to increase diversity and inclusion.
Dimensions of diversity
As we consider a move toward greater inclusivity, we must take into account the many forms of bias that place limits on our status quo. Diversity includes many distinctions our societies place on humanity, such as age, gender, ethnicity, religion, and socioeconomic status. Diversity concerns affect our industry in two streams: the professionals driving the work and the patients and volunteers we recruit to participate in our studies.
Speaking personally, my appreciation for diversity is borne of my unique experience as a professional woman of visible Sikh faith, of Punjabi descent, born in London, UK, and now living in Vancouver, Canada. Each of us has a unique perspective to offer and a unique opportunity to learn from the perspectives of others.
What do we know for sure?
Disease and illness do not discriminate, but there are distinguishing factors that influence how certain conditions and medical treatments affect our bodies. Clinical research leading to treatments approved for market must be representative of the intended patient population in the real world.
- Science demands diversity. From a purely scientific perspective, we have enough data to know that race, ethnicity, gender, genetics, and age all have implications for both disease presentation and medical interventions. For example, racial distinctions in skin structure and physiology are predictive of specific responses to dermatologic and topically applied products. As an industry, if we are to achieve reliable and conclusive data, our study cohorts must be representative of the patient populations our therapies are intended to serve.
- Privilege and bias are real. We know from experience that diversity will not be achieved simply by declaring our intention. Studies on implicit bias have shown that, on the individual level, we have a gap between well-meaning intentions and practical action.[iii] Knowing that we are all affected by implicit bias, self-reflection is a great place to begin our move toward organizational diversity.
- There is interplay between staff hiring and patient recruiting. The diversity of the group who designs and executes the clinical trial will organically inform its ability to attract and maintain participants representing a broader swath of the market. At the feasibility stage, as well as at the eligibility stage, we need the perspectives of individuals coming from traditionally underserved populations. Their insights will be key to achieving successful recruitment and retention.
- Learning is our business. As an industry, we know how data drives progress. We can learn from our work in the rare disease space, where small patient populations demand that we take heterogeneity into account. In such cases, comorbidities, concurrent medications, and social determinants must all be taken into consideration. We must learn to expand this inclusivity to therapeutic areas where patient populations tend to be larger and more homogeneous.
What have we yet to learn?
With respect to diversity and inclusion in the industry, we have reached a point of productive disruption. We know the aim, but we are still working out how to achieve it. I suggest the following areas where definitive action can achieve measurable results.
- Culture-sensitive recruitment and retention. Under-represented groups are inhibited by lack of awareness of their healthcare options, an overall distrust of clinical research, and financial and logistical concerns. Effective recruitment of study subjects, and subsequent retention, will require a strategy informed by an understanding the impediments to trial participation.
- Diversity in trial design. When protocols are designed with more attention given to understanding patient burden, there is opportunity to expand the pool of participants. Trial designers can assess protocols around primary, secondary and tertiary end points to better accommodate participant limitations.
- Engaging with research-naïve sites. While there are operational benefits in repeatedly working with the same study sites, we risk limiting our patient reach. Expanding our networks may require investment in training for inclusive language and behavior, as well as translation and interpreter services.
- Consolidating resources. Community and patient engagement are key to expanding our reach. Advocacy groups and diversity experts can provide valuable consultancy around both hiring practices and patient recruiting, as well as guidance on creating a culture of retention. Again, this is an area where the rare disease space has blazed a trail and subsequently found patient advocates to be valuable allies.
In the larger world, diversity and inclusion have become almost synonymous with equal opportunity, a matter of giving underserved groups access to employment, education, and many other aspects of society. In the therapeutic development space, diversity is a matter of medical and scientific knowledge, which may mean the difference between life and death for some patients. As an industry, we know good intentions are not enough. We must implement actionable commitments and transparent metrics to ensure our successes serve the whole of humanity.
Make diversity a part of your project
If you would like to learn more about how diversity initiatives can work for your clinical trial, you can reach out to me here or watch a recent panel discussion: Diversity, Equity, and Inclusion in Clinical Research.