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A recent paper offers consensus recommendations and examples of best practices from the published clinical trial literature to help authors and trial sponsors communicate drug adverse events in a more informative and clinically meaningful manner.1
“The intent of the paper is to help improve the reporting of safety outcomes from clinical trials,” says Jesse Berlin, senior vice president and global head of epidemiology at Johnson & Johnson in Titusville, NJ. Overall increased transparency is the overarching goal.
“Improving safety reporting is just one part of the broader emphasis across the research community on improving transparency with respect to our data,” says Berlin. Recent initiatives have focused on sharing both summary and participant-level data from clinical trials.
“Disclosure of all results — both favorable and unfavorable — is a visible demonstration that industry is reporting the benefits and the risks,” says Berlin.
The complete data set is then made available for those interested in performing further analyses. “Increased transparency is an ethical obligation we have to the people and care providers who have participated in studies, and those who use our products,” Berlin says.
Financial Disclosure: Consulting Editor Arthur R. Derse, MD, JD, Nurse Planner Susan Solverson, BSN, RN, CMSRN, Editor Jill Drachenberg, Editor Dana Spector, AHC Media Editorial Group Manager Terrey L. Hatcher, and Author Stacey Kusterbeck report no consultant, stockholder, speakers’ bureau, research, or other financial relationships with companies having ties to this field of study.