Translational Science Resources

Drug Development Illustrated: Infusing Equity Into Preclinical Research

Historically, the focus on equity and reducing disparities in biomedical research was most often applied within the context of clinical research or health care delivery. The preclinical environment — situated in the center of the biomedical research ecosystem and bookended by clinical research and health care delivery — was generally excluded because of the presumed objectivity of bench science research in this phase. This presumed objectivity led to a lack of attention paid to the impact of broader infrastructural and global disparities on the understanding of rare diseases and the inclusion of the communities that have been historically underserved and underrepresented in biomedical research.

NCATS recognized the absence of equity considerations in the preclinical research phase and identified ways to begin understanding and addressing these gaps. The Division of Preclinical Innovation (DPI) Therapeutic Development Branch (TDB) embarked on an initiative to infuse equity into preclinical research and drug development, with rare diseases as the exemplar.

Patients, advocates, community knowledge interpreters and research partners reported unfamiliarity with the specifics of the drug development phase and requirements to proceed after initial drug discovery. They conveyed a need for educational resources that describe the preclinical journey and detail the drug development process.

To address this educational gap and respond to partner feedback, NCATS DPI TDB developed a Knowledge Guide. This resource was created to help partners become familiar with the preclinical phase of the drug development process. The Guide is expected to inform and engage a broad audience; reduce knowledge disparities; and advance equity, especially in rare disorders and for those underserved and historically underrepresented in biomedical research.

The Knowledge Guide illustrates the drug development journey, starting from when a drug candidate is chosen. A team of multidisciplinary scientists uses project management best practices to move through a two-stage preclinical process toward clinical development (Figure A). Paired with Figure A is a step-by-step description of how scientists develop a drug that will be safe to test in humans (Figure B). The Guide also includes key concepts and highlights an ecosystem that conveys the importance of equity throughout the span of preclinical biomedical research (Figure C). The Guide also includes key concepts and highlights an ecosystem that conveys the importance of equity throughout the span of preclinical biomedical research (Figure C). For questions, contact TDB Program Staff.