The Adverse Events Reporting Initiative focuses on Recommendation 6 of the Ten Recommendations, which calls for reporting adverse event data in a more transparent and clinically meaningful manner to facilitate clinicians’ benefit-risk assessments. Despite availability of CONSORT guidance (Ioannidis J, et al. Ann Intern Med. 2004;141:781-788), balanced, clinically relevant, and more informative adverse event reporting is a significant unmet need, including specific guidance to help authors to better identify, communicate, and display clinically relevant adverse events (Ioannidis JP, et al. Arch Intern Med. 2009;169:1737-1739; Hodkinson A, et al. BMJ Open. 2013;3:e003436; Peron J, et al. J Clin Oncol. 2013;31(31):3957-3963).
In 2014, MPIP conducted interviews with 3 groups involved in adverse event data reporting—industry experts, journal editors, and clinical investigators—to better understand the process of adverse event data collection and how these data are reported in manuscripts. We then discussed these results with journal editors and industry experts to identify recommendations to supplement current guidelines and encourage clinically meaningful adverse event reporting in publications. A subset of these editors and MPIP industry representatives formed a working group to codify our consensus recommendations.
Recommendations to Improve Adverse Event Reporting in Clinical Trial Publications: A Joint Pharmaceutical Industry/Journal Editor Perspective provides guidance on clinically relevant and more informative adverse event reporting, to improve patient care and increase the credibility of industry-sponsored publications. Although developed for industry-sponsored trials, MPIP’s recommendations may be adopted to enhance adverse event reporting in clinical research publications regardless of the funding source and, thereby, better inform clinical decision making.
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.