Transparent and clinically relevant reporting of adverse event data has been identified as a significant unmet need in industry-sponsored publications. Although guidelines such as the CONSORT Harms Extension have improved reporting, poor adherence and a lack of specificity has seen suboptimal implementation of these recommendations. To this end, Medical Publishing Insights & Practices (MPIP) has held in-depth interviews with industry experts, journal editors and clinical investigators to assess current policies and best practices for harms reporting in clinical trial publications, with the aim to identify and address gaps in current guidelines. Based on a consensus process, MPIP has developed five recommendations intended to supplement existing guidance:
- Identify and communicate the most clinically relevant drug adverse event data as part of a comprehensive safety profile.
- Report timing, frequency, duration, and other potentially relevant descriptors when clinically appropriate.
- Use statistical analysis for clinically relevant adverse events (where appropriate).
- Avoid use of overly general text descriptions for adverse events, including in abstracts.
- Discuss adverse events findings in the broader context of available evidence and maintain consistency of data across different public reports.
The authors discuss how they aim to disseminate and encourage adoption of these recommendations, starting with implementation by MPIP members within their own research divisions. The authors will also encourage the adoption of the guidelines by non-industry groups given the common goal of improving the transparency and credibility of adverse event reporting in published manuscripts.