
- Applied Clinical Trials-02-01-2021
- Volume 30
- Issue 1/2
Diversity in Clinical Trials Gains Ground Amidst COVID
FDA emphasizes importance of inclusion in trials.
A prominent goal for biopharmaceutical research has been to broaden the range of participants in clinical trials to fully assess the impact of new therapies on different ethnic, racial and age groups. FDA has pressed for more inclusive research programs for drugs and medical products for decades to enhance the understanding of how medications affect certain populations differently. An early aim was to reverse established limitations on testing new products on women and both very young and elderly patients. More recent policies aim to offset years of under-enrollment of minority groups by expanding enrollment criteria, including more research sites in minority communities, and engaging investigators with diverse backgrounds. The visibly high impact of COVID-19 on minority populations in the US has focused added attention on the importance of including racial and ethnic minorities in clinical trials for pandemic vaccines and therapeutics.
Over the years, FDA has issued multiple guidance documents to encourage broader data reporting on research subjects of different races and ethnicities. In November 2020, the agency spelled out a range of strategies in a final document on
The importance of more inclusive clinical trials, moreover, has been emphasized for developing drugs and biological products for combatting COVID-19, as seen in a broad
New vaccines to combat the pandemic similarly should test these critical products on a broad spectrum of patients, FDA advises in a June 2020 guidance that spells out regulatory expectations for assessing vaccine manufacturing processes and facilities and both nonclinical and clinical data. The agency specifies that to ensure that vaccines are safe and effective for all indicated populations,
FDA has also sought to promote research diversity through its Drug Trials Snapshots program, established in 2015 to increase the visibility of clinical trial enrollment by age, sex, ethnicity and race. Under this program, the Center for Drug Evaluation and Research (CDER) posts a brief “snapshot” on demographic participation in clinical trials for each newly approved new molecular entity and biologic therapy. According to a recent report on the program’s impact, though, there still may be a ways to go for clinical trials to reflect the diversity of the US population.
The
The Snapshot report and related issues were discussed at a recent FDA
Jill Wechsler is Applied Clinical Trials' Washington Correspondent
Articles in this issue
over 4 years ago
Impact of COVID-19 on Phase I Clinical Activitiesover 4 years ago
Biden Pandemic Plan Highlights R&D Supportover 4 years ago
Applied Clinical Trials, January/February 2021 Issue (PDF)over 4 years ago
New Alliance Seeks to Bring Increased Accessibility to Trialsover 4 years ago
Improving Drug Development for Rare Patients Post-COVIDover 4 years ago
2021 Promises for Clinical Trialsover 4 years ago
Sharpening the Focus on Patient-Centricity as Pandemic Continuesover 4 years ago
News Notes (January & February)over 4 years ago
EMA’s Cooke Reviews European Cancer ProspectsNewsletter
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