> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Trial Inclusion, Exclusion Workshop Report
- URL: https://www.fdaweb.com/trial-inclusion-exclusion-workshop-report/
- Published: 2018-08-23T12:00:00.000Z
- Updated: 2026-09-15T00:27:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142181

An FDA 4/16 public workshop on Evaluating Inclusion and Exclusion Criteria in Clinical Trials addressed the underrepresentation of various populations in clinical trials, how eligibility criteria affect patient access to investigational drugs and enrollment in clinical trials, alternative clinical trial designs that may increase the enrollment of diverse populations, and whether the FDA expanded access program could provide an opportunity to facilitate access to investigational products. A [summary](https://www.fda.gov/downloads/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDARA/UCM613054.pdf?ref=fdaweb.com) of the workshop was released as required by the FDA Reauthorization Act of 2017, which also mandated that a public meeting be held to discuss clinical trial eligibility criteria to inform a guidance on the subject.

The workshop brought together representatives from academia, industry, healthcare delivery, government, and patient advocacy groups to discuss a variety of topics related to the subject, the summary says. “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,” it adds.