FDA Workshop: “Addressing Challenges in the Design and Analysis of Rare Disease Clinical Trials: Considerations and Tools”

On May 2 and 3, 2023, the FDA’s Center for Drug Evaluation and Research (CDER) and the Johns Hopkins University’s Center of Excellence in Regulatory Science and Innovation (JHU CERSI) will host a jointly sponsored virtual workshop on addressing challenges in the design and analysis of rare disease clinical trials.

This workshop will discuss:

  • How to collect high quality and fit-for-purpose data for rare disease clinical trials
  • Use of data sources to inform rare disease drug development
  • Design and analysis methodologies for use in rare disease clinical trials

For more information and to register for this workshop, please visit: CDER and JHU CERSI Rare Disease Workshop