Enhancing the QUAlity and Transparency Of health Research
Medical Publishing Insights and Practices (MPIP), the International Society for Medical Publication Professionals and representatives from the pharmaceutical industry have recently published guidelines to encourage clinically relevant and more informative adverse event reporting in clinical trial publications. The reporting guideline provides five consensus recommendations which supplement the guidance contained in the CONSORT Harms Extension.
Lineberry N, Berlin JA, Mansi B, Glasser S, Berkwits M, Klem C, Bhattacharya A, Citrome L, Enck R, Fletcher J, Haller D, Chen TT, Laine C. Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ. 2016;355:i5078.
The new guideline can be accessed at: adverse event reporting
In a previous post detailing my time with the EQUATOR Network, I spoke about my work on the STrengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. STROBE is one of the original “core” reporting guidelines which provides guidance...