Clinical trials provide the evidence base that allows us to judge whether a medical product actually works before it is approved for sale to the public. It is important that participants in clinical trials reflect the patient population who will actually use the product if it is approved.
It is also important that the widest possible range of people take part in trials and contribute to improved products and treatments. They also might be able to take advantage of a new therapy that could help them.
Poor representation in trials
Some groups have been poorly represented in clinical trials in the past. Surprisingly, one such group is the elderly, who are actually higher-than-average users of clinical products and therapies. Women and people from black and minority communities in the US have also been traditionally under-represented, particularly African-Americans.
Providers of clinical trial services have been aware for some time of the need for trial participants to reflect the diversity of society as a whole. Companies like richmond pharmacology who are a Patient Recruitment Services are a great company to go to when you need voluntary help from the public to take part in studies.
The FDA was given direction by Congress in 2012 to take action on this issue. As a result, the FDA now gives the public information on the demographic composition of trial participants in hopes of spurring greater diversity.
This issue is not simply one of representation. Different drugs can have different effects on different racial groups, and it is important that clinical trial services are able to capture this data during the trial. Another area in which diversity affects medicines is the difference in dose that may be appropriate and effective in men versus women.
FDA action on this issue
The FDA has an Office of Minority Health and the Office of Women’s Health, and both of these have been active in launching tools to support more involvement in clinical trials.
In addition, the FDA has been working with experts in trial design, biostatisticians and other scientists to develop improved conduct and analysis of clinical trials, so that the treatment effects are accurately estimated across the full diversity of the population.
One way of ensuring that clinical trials are relevant to the entire population is to include patient advocates early on in the trial design and take their feedback seriously. This engagement may encourage further involvement in the clinical trials process, which will benefit professionals and the public alike.