Making Clinical Trials Populations Better Represent Patients

Clinical trial participants are often not representative of the patient populations. People from marginalized backgrounds are often overlooked, leaving lingering safety and efficacy questions remaining for those already facing barriers to access. In a new PM Live, article, Paul Chew of Phesi discusses diversity in clinical trials and why it is critical in improving health equity efforts.

According to Chew, “Recently, the clinical development community has begun to address diversity in clinical trials. The European Medicines Agency (EMA) updated its Clinical Trials Regulation to ensure sponsors justify any non-representative procedures in January this year; this was followed by the US Food and Drug Administration (FDA), which issued new guidance on meaningful representation of racial and ethnic groups in April. To ensure these measures have the desired impact on trial participation, a patient-centric approach is needed. By harnessing the advanced technological capabilities now available, greater insights can be taken from data. There is also pending US legislation aimed at increasing diversity in clinical trials.”

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(Source: PM Live, December 14^th, 2022)