Summary Report Available from the Public Workshop: Evaluating Inclusion and Exclusion Criteria in Clinical Trials

Summary Report Available from the Public Workshop: 

Evaluating Inclusion and Exclusion Criteria in Clinical Trials

FDA and Duke-Robert J. Margolis, MD, Center for Health Policy held a public meeting April 16, 2018 to discuss clinical trial eligibility criteria as required in Section 610 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017. FDA is publishing this report summarizing the topics discussed and the major points explored with stakeholders during the workshop.  This report is intended only as a summary of the workshop and does not provide guidance or reflect FDA’s current thinking on this subject.

 

The workshop provided an opportunity for representatives from academia, industry, health care delivery, government, and patient advocacy groups to discuss a variety of topics related to eligibility criteria in clinical trials.  The discussions at the workshop will inform FDA guidance on these issues.

For more information, please visit: Summary Report Available from the Public Workshop: Evaluating Inclusion and Exclusion Criteria in Clinical Trials.