Diversity, equity and inclusion in clinical research - where to go from here?

With the recent executive orders from the US and pushback against DEI, there is understandable alarm in the clinical research and health equity circles. Perhaps this is the right moment to think about the bigger picture. Diversity, equity and inclusion in clinical trials is not only a social justice issue. It is a drug safety issue with a strong business case.

Now is the time to move away from the preceding trend of single champions within organizations who push for diversity and inclusion, and work to integrate health equity into our mandates.

The topic of diversity in clinical trials is rooted in science. So, with regulators’ pushback against DEI, let’s talk about re-branding. Many have talked about how the FDA’s Diversity Action Plans might have been better named as “Representation Action Plans.” Diversity in and of itself is not the end goal, but rather to have clinical trial participation that is representative of the burden of disease (or the patient population affected by the disease).

The FDA mandate requiring DAPs has certainly been a catalyst for the life sciences industry and created much needed momentum to serve under-represented groups and improve the drug development process. Other countries have taken note and are following suit – which just shows that the recent executive orders cutting out DEI do not cancel certain truths:

1. There are groups who have been historically excluded from clinical trial participation, including women, ethnic/racial groups, sexual and gender minorities, people living with disabilities, the elderly, the young, people living in rural areas, and the list goes on.
2. Lack of appropriate representation in clinical trials prevents us from understanding the heterogeneity of treatment effect among population sub-groups, thereby limiting our knowledge of drug safety and efficacy. In the best case, we get lucky and trial results are generalizable to the wider population without significant differences in treatment effect and safety. In the worst case, we miss significant safety information or fail to notice lack of treatment effect for some, which would jeopardize the health of entire population groups.

Though it seems like there is going to be less pressure from regulators in the coming years to think about health equity in the drug development process, the rest of us have more of a responsibility to hold industry accountable. It's time to get creative, and not to lose hope.

#DEI #healthequity #clinicaltrials