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Initiatives - Adverse Events


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).

 

Methodology


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.

Publication


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.

Recommendations to Improve AE Reporting
  1. Identify and communicate the most clinically relevant drug adverse event data as part of a comprehensive safety profile.
  2. Report timing, frequency, duration, and other potentially relevant descriptors when clinically appropriate.
  3. Use statistical analysis for clinically relevant adverse events (where appropriate).
  4. Avoid use of overly general text descriptions for adverse events, including in abstracts.
  5. Discuss adverse events findings in the broader context of available evidence and maintain consistency of data across different public reports.

10 Recommendations

  1. Answer clinically important questions
  2. Report all results
  3. Improve COI disclosure
  4. Educate authors on manuscript development
  5. End ghost writing and guest authorship
  6. Improve adverse event reporting
  7. Provide access to protocols
  8. Report statistical methods transparently
  9. Ensure authors can access study data
  10. Support sharing of prior reviews

Learn More

AE Manuscript


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.

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