The following is an excerpt from our free whitepaper “Ending Racial Disparities in Clinical Trials.” Click here to download your copy.
It’s a fairly well-known fact in healthcare that minority populations are consistently underrepresented in clinical trials, but the breadth and depth of the problem might surprise you. Consider this handful of examples:
- Ninlaro, a drug used to treat multiple myeloma, was approved by the Food and Drug Administration (FDA) based on a trial in which just 1.8% of participants (13/722) were Black. By contrast, 20% of multiple myeloma patients are Black.
- African Americans make up 13.4% of the US population. Yet, in clinical trials for the 31 cancer drugs that have been approved since 2015, African Americans accounted for just 5% of trial participants.
- Asians account for about 6% of the US population, but represent only 1.7% of clinical trial participants.
- Native Americans and Alaskan Natives account for 2% of the US population, but have not been represented at all in two-thirds of drug trials conducted in the US.
- Trials for both Alunbrig and Alecensa, treatments for non-small cell lung cancer, had less than 2% Black participants, even though non-small cell lung cancer occurs in 56 of every 100,000 Black Americans versus 49 of every 100,000 white Americans.
- Prostate cancer affects 178 of every 100,000 Black Americans versus 106 of every 100,000 white Americans, and Black Americans are twice as likely to die from prostate cancer. However, in all seven prostate cancer trials conducted from 2009-2015, only 3% of the participants were Black.
- Study populations for Erleada, a newer prostate cancer treatment, were 66% white and just 6% Black.
Concerned about statistics like these, Congress in 2012 attempted to encourage greater inclusivity in clinical trials via Section 907 of the Food and Drug Administration Safety and Innovation Act. Section 907 directed the FDA to produce a report that examined the inclusion and analysis of demographic subgroups in biomedical research. In the resulting “Action Plan to Enhance the Collection and Availability of Subgroup Data,” the FDA detailed 27 actions divided into three priorities: improving subgroup data collection and reporting, identifying barriers to subgroup inclusion in clinical trials, and making demographic subgroup data more transparent.
Unfortunately, enforceable regulations were vague and limited to information about the trial subjects’ demographics and lacked a mandate for participation minimums. FDA spokeswoman Gloria Sanchez-Contrearas stated that the organization did not have the regulatory authority to require specific minority representation in clinical trials.
As a result, in 2020, correcting the disparity remains a problem for others to solve.
This post was excerpted from our free whitepaper “Ending Racial Disparities in Clinical Trials” Click here to read the whitepaper in its entirety,