Rare Disease Report

The FDA Wants More Diversity and Participation in Clinical Trials

JANUARY 10, 2017
Andrew Black
The FDA has released a consumer statement discussing the encouragement of more participation and diversity in clinical trials. While the FDA does not typically conduct the trial, the organization wants to make sure everyone is represented during studies, and tying into that, is receiving more participation to start.

Diversity in studies

The FDA wants to make sure each ethnicity and gender is involved in studies for the risk or benefit of a medical product. Certain types of people may be more at risk for certain diseases than others.
Previous experience has shown that there can be important differences in how people of diverse groups respond to some medical products. That known information is included in the product labeling which helps doctors and patients make treatment decisions.
The FDA’s Office of Minority Health also has tools to encourage people and their health care providers to learn about trials, including public service announcements


While clinical trials are solely voluntary, the only way to get that much closer for treatments, is to actually have people involved in the studies. There are several reasons why patients do not sign up for a trial. For example, most patient’s doctors conduct clinical research. Also, it may be difficult for some patients to find the time or have the resources to get to a trial site.

Recently, Uber and Lyft announced they are working on a plan to help patients get to clinical trials in a more accessible way. This might encourage more patients to volunteer.
A trust-factor tends to play a part in the lack of participation in a drug’s study. Some patients may not trust medical research due to historical mistreatment of study subjects that have been recorded in the past.
But there are several benefits to participating in clinical trials that those on the fence should be aware of. For example, you are helping more than just yourself in the development of treatments. Although you may not directly benefit during a clinical trial, the information collected can add to scientific knowledge and help with future research and product development.
Those who volunteer in clinical trials will likely receive the highest standard of current care for their condition, and will know that the FDA is committed to protecting participants of clinical trials and to ensuring that people have reliable information.

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