FDA Commits to Increasing Diversity in Clinical Trials
A new FDA bill is set to improve the recruitment of subjects from previously under-represented racial and ethnic groups for clinical trials.
The legislation, passed as part of an omnibus at the close of 2022, requires drug sponsors to submit a diversity action plan to the FDA on or before the date for submission for phase III trial protocol.
In addition, the FDA will also be required to update existing guidance on diversity action plans for enrolment by age and sex, as well as racial and ethnic demographic characteristics.
The move towards increasing diversity in clinical trials marks a step towards ensuring they reflect the safety and efficacy of novel treatments in all relevant patient populations.
However, at present there is ambiguity concerning what action the FDA may take against sponsors who fail to achieve their enrollment goals.
Outside the US, the EMA updated its Clinical Trials Regulation last year to ensure its sponsors justify any non-representative processes, promoting a patient-centric approach.
Any enforcement of this will depend on consistent metrics across government bodies and healthcare providers, as well as pharmaceutical bodies.
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This is very much a contemporary issue for the UK at present: between 2007 and 2022, only one in four clinical trials with UK participation reported on racial or ethnic data.
Without diverse participation in clinical research, there is a lack of breadth in safety and efficacy data.
This has implications for the development of a range of therapeutics including clinical biomarkers, as well as ensuring new approaches are safe for patients.
The MHRA announced last March that it was taking steps to ‘improve and strengthen the UK clinical trials legislation’, which included a move towards the greater inclusion of underserved populations.
As of yet, it is unclear if any changes have been put in place with a view to increasing diversity in clinical trials following the subsequent consultation.
Biomarkers serve a range of practical uses in clinical trials: as a tool for improved diagnostics, molecular structures can be used to increase diagnostic accuracy in both the general population and at-risk populations.
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