«Missing» or «hidden» data from unpublished clinical trials is crucial for medical society to get a more reliable assessment of medicines and medical devices.
MPIP (Medical Publishing Insights & Practices) – an organization founded by pharmaceutical companies – and the International Society for Medical Publication Professionals (ISMPP) developed a set of recommendations on adverse event reporting in clinical trial publications. The article published in British Medical Journal summarizes the experience of past years and offers some ways to improve adverse event reporting.
The purpose of the guidance is to make such data available, clearly understandable and well-illustrated. Moreover, authors oppose using of some prevalent generalizations without proper evidence provided. Authors found unproven statements like «safe», «well tolerated», «no clinically significant or unexpected adverse events» in 6000 publications from 1990 to 2015.
MPIP calls industry to stop hiding adverse event data in the backyard and offers to speak of it freely, performing statistical analysis on it and including the results even into abstract. The article also provides some examples of proper data publishing. The guidance is primarily addressed to pharmaceutical companies and states that if industry comes out with adverse event data it will only benefit from such transparency.