Drugs

Public Meeting on Clinical Study Quality

David McFarland

— 1 min read
Share

FDA and the Duke-Margolis Center for Health Policy are holding a hybrid (online/in-person) public meeting 1/31 on “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.”

The meeting is intended to discuss with stakeholders the challenges and successes when integrating QbD and RBM into clinical study design and conduct. The meeting objectives are to:

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

For years, FDA says it has encouraged the use of QbD and RBM through many outreach activities, such as co-hosting a 2019 public workshop in 2019 on implementing RBM approaches in clinical investigations. FDA has also recently published several guidances on the topics, including 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.

Read more