LS&HC Horizons 2022 - Flipbook - Page 11
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
11
Clinical Trials
Diversity in clinical trials
Robert Church
The Covid-19 pandemic illuminated health and health outcome
inequities in the United States. Pharmaceutical industry
stakeholders, from government to manufacturers, have begun to
recognize that meaningful representation of diverse participants
in clinical trials can address health inequities facing historically
underrepresented populations. Several bills that promote the
inclusion of underrepresented groups in clinical trials have been
introduced in Congress. The proposed legislation takes many
approaches to increasing diversity, from requiring sponsors to
report clinical enrollment targets to the FDA to directing and the
Department of Health and Human Services (HHS) to develop
guidance about patient recruitment and leveraging decentralized
clinical trials to promote diversity.
Partner, Los Angeles
Stephanie Agu
Associate, Washington, D.C.
Akosua Tuffuor
Associate, Washington, D.C.
FDA has also continued to prioritize efforts and initiatives to address
clinical trial diversity. As an important preliminary step, FDA issued
a guidance document in November 2020 on Enhancing the Diversity
of Clinical Trial Populations. More recently, FDA issued guidance
on the use of digital health technologies in remote clinical trials
and highlighted digital health technologies as a tool to increase the
inclusion of diverse populations in clinical trials. Earlier this year,
FDA’s Center for Devices and Radiological Health also released its
Health of Women Program Strategic Plan to address sex- and genderspecific data gaps. We expect Congressional and agency focus on
diversity to persist and will keep clients abreast of this everchanging
policy landscape.
Many sponsors have independently announced goals to increase the
recruitment of underrepresented minorities in clinical trials. With
our knowledge in clinical trials diversity initiatives, we advise clients
on balancing their clinical trial diversity goals with compliance with
legal requirements and bioethical standards pertaining to patient
recruitment and outreach, data analysis, protocol design, and more.
Visit our website to learn
more about our Clinical
Trials work.
