Coalition’s Comments on FDA’s Efforts to Improve Diversity and Analyses in Clinical Trials

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Food and Drug Administration

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Comments of members of the Patient, Consumer, and Public Health Coalition on FDA’s Efforts to Improve Diversity and Analyses in Clinical Trials Docket No. FDA-2015-N-4952

We are writing as member organizations of the Patient, Consumer, and Public Health Coalition, to express our views on the need for diversity and subgroup analyses in clinical trials.

We support efforts to improve the safety and effectiveness of drugs and medical devices for ALL patients that are likely to use them. Women, people of color, and patients over the age of 65 have often been under-represented in clinical trials. Just as that was improving in recent years, efforts to speed drug approval have resulted in smaller clinical trials. So, the numbers of patients in those groups are again shrinking, making it impossible to do meaningful analysis of safety or effectiveness.

For example, cancer is most common in the elderly, but many cancer drug trials include very few elderly patients. Cancer drugs are often more toxic and less effective in the elderly. But with so little information on elderly patients when a drug is approved, it can be years later that we learn that elderly patients are more likely to be harmed if approved dosing information is followed.

The National Center for Health Research recently examined drugs reviewed by FDA Advisory Committees in 2014. They found that, for the 24 drugs the committees reviewed, 7 sponsors did not even tell FDA how many patients in their studies were 65 and older. That is a crucial subgroup for Medicare to make coverage decisions, and should always be analyzed separately. An additional 2 sponsors included fewer than 30 patients 65 and older. In other words, over onethird of the drugs were not studied on enough patients over 65 to draw even the most preliminary conclusions about safety or efficacy.

Similarly, over a quarter of the drugs did not include at least 30 African Americans – some didn’t even include 10! It is impossible to conduct meaningful subgroup analyses with such a small number of patients.

And although women were always included when appropriate, 23% of drugs did not include a subgroup analysis to determine if the drug was safe for women.

Here’s one egregious example. FDA did not require subgroup analysis of Blacks when the company submitted clinical trials for Singulair for asthma in 2014, despite previous evidence that the drug did not work for Blacks.

The FDA should make it clear that the agency will not approve medical products for all populations if meaningful subgroup analysis for safety and effectiveness were not conducted for major demographic groups. 

We do not believe that the major impediment to diversity in clinical trials is the lack of interest of women, people of color, or patients over 65. Inconvenient locations are a major impediment, however. Companies have not done a better job of recruiting because they know FDA will approve their drugs even when adequate subgroup analyses are not conducted.

In the same way that companies recruit the best possible physicians by providing generous incentives to participate in clinical trials, companies should do the same to make participation in clinical trials possible and affordable (and even attractive) for patients of limited financial means or with limited resources.

Most important, the FDA needs to make it clear to companies that if they want their drugs approved for women and men, whites and people of color, and adults of all ages (and especially Medicare beneficiaries), they need to study sufficient numbers of those patients in subgroup analyses to make sure the drugs are safe and effective for them in the short-term and long-term.

American Medical Women’s Association

Annie Appleseed Project

Breast Cancer Action

Breast Cancer Consortium

Center for Medical Consumers

National Center for Health Research

National Organization for Women Foundation

Our Bodies Ourselves

Washington Advocates for Patient Safety


The Patient, Consumer, and Public Health Coalition is an informal coalition of nonprofit organizations representing the interests of millions of patients, consumers, health-care professionals, scientists, and public health experts. The coalition can be reached through Tracy Rupp at (202) 223-4000 or at

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