Publication
Published on: October 6, 2026
Published in: Clinical Pharmacology & Therapeutics
Description: “Exclusion of Participants for Substance Use in Clinical Trials,” published in Clinical Pharmacology & Therapeutics and led by Willyanne DeCormier Plosky of the MRCT Center with co-authors Benjamin C. Silverman of Mass General Brigham, David H. Strauss of Columbia University, and Barbara Bierer, analyzed ClinicalTrials.gov protocols to learn whether people who use substances are excluded from clinical trials, and why. The authors found that 43% of interventional protocols (110 of 254) excluded people who use substances, and that protocols defined substance use inconsistently, varying by level, timing, and type of substance. Most of those studies (63%) gave no rationale or none specific to substance use. The authors argue that inclusion should be as broad as the study question allows and exclusion only as narrow as participant safety and scientific validity require and call for guidance that standardizes how substance use is defined and assessed in eligibility criteria. When people who use substances and their healthcare providers determine it is appropriate to participate in clinical trials, the generalizability of safety and efficacy data for the medical products tested in the study may be improved.
