Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches

Meeting Background and Objective:

Quality by design (QbD) and risk-based monitoring (RBM) approaches facilitate clinical trial modernization by enhancing efficiency without compromising data integrity or participant protections. The U.S. Food and Drug Administration (FDA) has encouraged the use of QbD and RBM through many outreach activities, such as co-hosting a public workshop in 2019 on implementing RBM approaches in clinical investigations.  FDA has also recently published several guidance documents on these topics, such as E6(R3) Good Clinical Practice, A Risk-Based Approach to Monitoring of Clinical Investigations – Questions and Answers, and E8(R1) General Considerations for Clinical Studies. Despite the efforts of FDA and other interested parties, QbD and RBM approaches to plan and conduct of clinical investigations have not been fully utilized.  Additionally, as the COVID-19 pandemic necessitated changes to clinical trial design and conduct, recent experiences may help to inform the development of best practices for implementing QbD and RBM moving forward.  This public workshop, convened by Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, is an opportunity to facilitate a discussion among the clinical trials community and interested parties about challenges and successes of integrating QbD and RBM into the design and conduct of clinical studies. The objectives of this meeting are to:

• Encourage the incorporation of QbD principles into the design and conduct of clinical studies, including the development of study protocols and workflow processes
• Identify barriers to QbD and RBM implementation by sponsors, clinical research organizations, and clinical trial sites
• Inform best practices for incorporating QbD and RBM approaches into the design and conduct of clinical studies

Funding Acknowledgement:

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD006807 totaling $3,193,089 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.