National Academies Stresses ‘Urgent’ Need to Recruit More Diverse Patients For Clinical Trials

National Academies Stresses ‘Urgent’ Need to Recruit More Diverse Patients For Clinical Trials

May 20th, 2022 // 7:28 pm @

The lack of diversity among patients in clinical trials is a serious issue that negatively affects those who have been left out of clinical studies, as well as the whole biomedical research field, according to a report issued this week by the National Academies of Sciences, Engineering, and Medicine.

The report noted that there is a major need to move clinical trials away from white men only, which requires a change of thinking that provides less power to medical organizations that pay for and do clinical research and more to the communities being studied.

The report was fairly stern in its tone and said getting funding to recruit a more diverse set of trial patients should be the emphasis and enforced going forward. Investing in more diverse clinical trials could bring a lot of cost savings as the health disparities in the country are reduced.

A clinical research industry that is more diverse would include clinical trials and studies that match the demographics of the disease burden that is being studied, the report noted. But the goal is far from being achieved.

The report pointed out many clinical trials that have a lack of patient diversity, even for medical conditions that affect people of color the most. One FDA analysis of clinical studies between 2015 and 2018 found that 80% of patients were non-Hispanic whites. And more than 97% of those in a Phase II trial for the Alzheimers’s drug crenezumab were white and 3% were Hispanic. But those of Hispanic origins are 1.2 times more likely to get the disease, the report stated.

The dearth of diversity stays even though there has been decades of attention to the problem, as well as many reports. There even have been new offices created in the federal government to recruit a more diverse population of patients.

A GAO report in 2015 found there had been little improvement in clinical trial diversity since 2004. Even today, most trial participants are white and male.

Diversity targets for trials are rarely enforced, the report continued, and they recommended more efficient tracking of trial patient diversity. Also, the report urged that funds for trials be withheld if they miss diversity goals.

To understand why diversity in clinical trials matters, the authors pointed to the blood clot inhibitor warfarin. The drug has been approved for about 70 years, but it wasn’t until a decade ago that researchers understood that genetic ancestry affected how the medication should be dosed. People who have an Asian background need lower doses and had excessive bleeding when the drug was given with too high of a dose. The clinical trials done on warfarin were done almost entirely on white men.

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