FDA Aims for More Diverse Clinical Trials
March 10, 2016
by Amanda Conschafter, blog editor
The Food and Drug Administration is on a mission: Make 2016 the year of diversity in clinical trials. Congress first tasked the FDA with improving diversity in 2012 through the Food and Drug Administration Safety and Innovation Act. Now the FDA is putting an action plan into motion. Through a multi-prong, multimedia effort, the FDA hopes to educate and mobilize a more diverse cross section of the population to participate in clinical trials.
To demonstrate a medication’s safety and efficacy for all patients, clinical trials should enroll a diverse cross section of the population. As FDA’s Commissioner of Food and Drugs Robert M. Califf, M.D., explained in a blog post earlier this year:
…Certain groups of patients may respond differently to therapies. For example, studies for a recently approved schizophrenia drug found that one side effect – the urge to move constantly – was seen more often in black/African-American patients. Two important classes of blood pressure drugs were found to work less well in black patients… We also have seen labeling changes due to differences in dosing requirements between men and women….
But too often, clinical trials populations look more homogenous than desired. Thus, to make good on Congress’ directive, the FDA has unveiled a variety of tools to increase diversity:
- The Diverse Women in Clinical Trials initiative, launched by the FDA’s Office on Women’s Health to increase awareness and share best practices.
- Clinical trials participation tools, developed through the FDA’s Office of Minority Health, includes multimedia components to encourage underrepresented people to learn more and consider enrolling in clinical trials.
- Drug Trials Snapshots, which provides information to consumers about who participated in clinical research for a specific drug.
- Continued feedback, evaluation and engagement with patient advocacy groups.
Last year’s 21st Century Cures Act also alluded to the need for diversity in clinical trials. The bill explains that “it is the sense of Congress” that the United States should “work to increase representation of underrepresented communities in clinical trials.” The bill suggests that the National Institute on Minority Health and Health Disparities incorporate the effort into its mission. It remains to be seen whether the language will also appear in the Senate version of the bill, now under consideration by the Senate Health Education, Labor and Pension committee.
For more on the need for clinical trials awareness and greater participation, visit www.CCTAwareness.org.Tags: Regulatory Issues
Categorized in: Blog