Article | April 19, 2021

Practice Follows Principles: More Inclusive Patient-Centered Development & Commercialization

Source: DIA

By Hilary Wilson, Boehringer Ingelheim, Cleonette D. Cudjoe, Patient Advocate, and Jen Horonjeff, Savvy Cooperative

Diversity iStock-1285126883

Underrepresentation of Black and Indigenous people of color (BIPOC) and other racial and ethnic minorities in clinical trials is a longstanding issue. The disparate impact that COVID-19 has had on BIPOC, Hispanic, Latinx, and Asian communities, combined with the underrepresentation of these subgroups in some COVID-19 clinical trials, has brought a sense of urgency to address this historic challenge. Within the past year, the Pharmaceutical Manufacturers of America (PhRMA) released the first industry-wide principles on clinical trial diversity; the Multi-Regional Clinical Trials Center published the “Achieving Diversity, Inclusion, and Equity in Clinical Research” guidance; and the US FDA released a final guidance to encourage the inclusion of groups that are often overlooked in clinical trials.

Industry will not be able to address underrepresentation of racial and ethnic minorities in clinical trials if the approach is a reactive scramble each time a trial launches. Instead, inclusive design should be built into the entire process. Inclusion is a core principle of patient-centric drug development and requires directly engaging with patients to co-create solutions that address unmet patient needs. It is paramount to ensure that diverse patients are included in this process, otherwise one risks innovating only for a subset of the population and exacerbating health disparities.

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