The US Food and Drug Administration (FDA) has issued final guidance on designing and executing clinical trials of drugs and biologics to enhance diversity.
The guidance ‘Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs’ has been issued with the agency’s recommendations on executing the trials of drugs that include people with different demographic and non-demographic characteristics.
Initially issued as a draft last year, it provides the FDA’s exiting thinking on methods to widen eligibility criteria through inclusive trial practices, designs, and methodological approaches.
In June last year, the FDA issued draft guidance to encourage drug developers to enrol more patients in clinical trials.
This final guidance aims to provide recommendations for how sponsors can increase the enrolment of underrepresented populations in their clinical trials.
As part of the guidance, recommendations are also available on how they will be able to improve clinical trial diversity by accounting for logistical and other factors that could limit participation.
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The FDA said in a statement: “Additionally, this guidance provides recommendations on broadening clinical trial eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases and recommendations on improving enrollment and retention of participants with rare diseases.”
Furthermore, the guidance requires sponsors to consider early engagement with patient advocacy groups and patients should elicit suggestions for designing trials.
Participants should be willing to enrol in and support these clinical trials.
Other high-level considerations about the inclusion of other important groups are also part of the guidance. The groups also include women, including pregnant women, racial and ethnic minorities, children, and older adults.