Expanding The Tent: Improving Trial Participation Among Under-Represented Patient Populations

New Tufts CSDD Research Creates A Baseline For Change

The biopharma industry has struggled to recruit patients into clinical trials that adequately reflect the diverse patient populations they hope to reach with new products. Failure to improve minority subgroup participation now will cost trial sponsors later.

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Inclusive clinical trials are needed to expand evidence development • Source: Shutterstock

The strength and authority of science in society, such as it is, relies on a commonly held belief that scientific findings are objective and impervious to the biases of its practitioners. Scientific facts – including the way human bodies respond to medical interventions – must be recognized and trusted as facts, until new studies and experiments come along to update the old facts or replace them. Identifying and controlling for variables during a clinical study is a key principle of the scientific enterprise, one that distinguishes rigorous and actionable conclusions from studies that distort reality, lead to poor policy decisions, or worse.

All studies have limitations, whether they are acknowledged or not: human biology, including the function of roughly 20% of proteins in the body, for example, remains a mystery. The mechanism of action for many drugs used to treat central nervous disorders, for another example, are not well understood. And yet, scientists and clinicians have uncovered important distinctions between individuals across ethnicity, gender and age groups, and how they respond differently to specific medications

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