15 Feb Diversity in clinical trials: Advances and areas for improvement

By Otis Johnson, The Association of Clinical Research Professionals (ACRP)

I am encouraged by how focused we are as an industry on addressing the serious underrepresentation of diverse populations in clinical trials.

Although I was quite happy that the U.S. Food and Drug Administration (FDA) issued a draft guidance last year on improving patient diversity in clinical trials, I saw room for improvement and provided feedback through two industry consortia. I felt that the guidance was not powerful enough. The language was not strong enough to drive the action needed to make clinical trials more diverse. Throughout the draft guidance, there are reminders that these are nonbinding recommendations. In other words, they are optional, and it is OK if you choose not to follow them. There are no consequences and no incentives.

As I was reading the draft guidance, I reflected on my days at Merck designing clinical trials for new therapies for respiratory conditions. We would retrieve the relevant FDA guidance for industry and would follow it exactly. We did this because there was an inherent fear that if we did not follow the guidance, this might ultimately jeopardize the approval of the investigational drug. While reading the draft guidance on how to increase patient diversity in clinical trials, I was hoping to experience that same feeling. Unfortunately, I did not. In other words, the diversity guidance seemed less authoritative than indication guidance. Read more …