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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.
1. Lineberry N, Berlin JA, Mansi B, et al. Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ 2016; 355;i5078.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Dana Spector, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, RN, PhD, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.