FDA plans greater diversity in clinical trials
pharmafile | January 29, 2016 | News story | Medical Communications, Research and Development | FDA, Robert Califf, clinical trial, patient recruitment
The FDA is to focus on increasing patient diversity in clinical trials in 2016, to “ensure that research participants are representative of the patients who will use the medical product”, according to Commissioner-in-waiting Dr Robert Califf.
In a blog post for the Food and Drug Administration, Califf, who is widely expected to head up the FDA having secured the vote of a senate panel in January, says it is important a wide range of people have the opportunity to participate in clinical research, but he notes that historically, such groups as the elderly, ethnic minorities, and even women have been “underrepresented in trials.”
Califf comments: “A wide range of people should have the opportunity to participate in trials, both for access to new therapies and to have the chance to contribute to better treatment of everyone, an important altruistic goal for many Americans.”
He goes on to says that while the FDA has responded to this issue with such policies as the creation of Drug Trials Snapshots – which give the public details of the demographic profile of people participating in clinical trials for approved drugs – there is still much work to be done, and the FDA intends to implement several additional measures in 2016.
These include:
- The development of a variety of tools by the FDA’s Office of Minority Health, to support clinical trial participation, including collaboration with the National Library of Medicine to help consumers and patients find clinical trials, educational materials on trials, as well as a multi-media campaign highlighting the importance of clinical trial participation. The FDA believes these will help encourage those underrepresented in clinical trials to find out more information, and consider enrolling
- The launch of the Diverse Women in Clinical Trials initiative by the FDA’s Office of Women’s Health. This multi-pronged effort will raise awareness and share best practices about clinical research design, recruitment, and subpopulation analyses
- FDA biostatisticians, trial design experts, and quantitative scientists continuing to work with the research community to develop methods to refine the Administration’s approach to the conduct and analysis of trials, to provide more accurate pictures of treatment effects for diverse populations
- Continued commitment to the inclusion of patient advocacy groups to engage patients in clinical trial design, feedback and evaluation from patients’ perspectives. By engaging patients early in the trial design process, feasibility and participation may be improved, Califf’s post says
- The FDA’s Office of External Affairs will publish a consumer update describing the experience of participating in a clinical trial, which it hopes will encourage the public to enrol in such trials.
Califf said these measures would help make 2016 “the year of diversity in clinical trials”, and promised progress updates as the year continues.
Joel Levy
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