- •2 tools measuring misuse, abuse, & related events in clinical trials are available.
- •SR-MAD can be easily implemented, but may lead to event underreporting.
- •At present, MADDERS is best suited to assessing events in clinical trials.
- •Additional study of these 2 tools in prospective randomized trials is needed.
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The views expressed in this article are those of the authors, and other than employees of Analgesic Solutions, none of the authors have financial conflicts of interest related to the specific issues discussed in this report. Analgesic Solutions developed the Misuse, Abuse, and Diversion Drug Event Reporting System with input from the other authors. Carl L. Roland and Beatrice Setnik were both employees of King Pharmaceuticals, later Pfizer Inc, during the development of the Self-Reported Misuse, Abuse, and Diversion instrument. The findings, conclusions, and recommendations contained in this report are those of the authors. No official endorsement by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, or the pharmaceutical companies that provided unrestricted grants to support the activities of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the FDA should be inferred. At the time of the consensus meeting on which this article is based, 7 of the authors were employed by one of the companies that provided unrestricted grants to ACTTION to support its activities, including the consensus meeting. These companies were Collegium Pharmaceutical, Inc, GW Pharmaceuticals, plc, Horizon Pharma, Inc, Janssen Scientific Affairs, LLC, Pfizer Inc, and Purdue Pharma LP. Authors of this article who were not employed by industry or government at the time of the meeting received travel stipends, hotel accommodations, and meals during the meeting provided by ACTTION. ACTTION has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, and other sources. Preparation of this article was supported by ACTTION. No external funding was received for the meeting or the preparation of this article.