DEI Special Edition Spring / Summer 2024
Diverse (Proportional) Participation in Clinical Trials: a Scientific Necessity
by Arati “Arti” Bhosale, BDS, MPH
OVERVIEW: In the complex world of clinical research, the call for diverse participation in clinical trials has transformed from an ethical suggestion to an undisputed scientific necessity. This requirement of representative participation stems not only from ethical considerations but, also from the recognition that the lack of diverse participation has profound implications on the efficacy and safety of medical interventions. It is evident that the scientific community is at a crossroads, challenged to align research practices with the diverse reality of the real - world prevalence of health conditions.
REAL WORLD SCENARIO: REAL - WORLD PREVALENCE FACTOR:
Historically, clinical trials have lacked proportional representation, often fail- ing to mirror the real - world prevalence of health conditions. This discrepancy raises a red flag – can we truly claim a medical breakthrough is universally effective when the pool of participants does not mirror the broader spectrum of those affected by the condition? REAL WORLD EXAMPLES: The repercussions of this historical oversight come sharply into focus when we examine post - market use of FDA - approved drugs. BiDil and Zolpidem serve as notable examples. Other examples are medica- tions such as: Statins and Cholesterol, Anti - diabetic, Anticoagulants (Blood Thinners), Opioid Medications, ACE Inhibitors for Hypertension. REAL WORLD EFFECTS: The lack of diverse participation in clinical trials can have significant conse- quences for drug development, including:
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