# Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/enhancing-participation-in-clinical-trials-eligibility-criteria-enrollment-practices-and-trial-designs-guidance-for-industry/cb854ea3-a48e-47fc-aa09-ec209539e6a9 > FDA guidance document: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry. Issue date: December 15, 2025. Get complete insights and analysis. --- ## Details - Title: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2025-12-15 - Last Changed: 2025-12-15 - Docket Number: FDA-2019-D-1264 ## Related Documents - [Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-trial-endpoints-for-the-approval-of-cancer-drugs-and-biologics-guidance-for-industry/2ab76b05-d847-445c-b212-0047a592f760) - [Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/adjusting-for-covariates-in-randomized-clinical-trials-for-drugs-and-biological-products/f58b2adc-b92a-4458-b269-5346d25a8a39) - [E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/e9r1-statistical-principles-for-clinical-trials-addendum-estimands-and-sensitivity-analysis-in-clinical-trials-guidance-for-industry/e136fe4a-71f3-4725-890a-e85d5d6c6414)