Recommendations to improve adverse event reporting in clinical trial publications11/10/2016
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