Intended for healthcare professionals

Rapid response to:

Research Methods & Reporting

Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective

BMJ 2016; 355 doi: (Published 03 October 2016) Cite this as: BMJ 2016;355:i5078

Rapid Response:

No more hiding

We do not need more filters and publication guidelines but full reporting. It is unrealistic to think that a publication in a medical journal that takes up 10 pages can fairly represent harms data from a clinical study report that takes up a 1000 pages. Harms data is heterogeneous and a lot is lost in tables showing only broad categories.

The authors suggest reporting “most clinically relevant” adverse events. As it is subjective it will be susceptible to bias and it is not possible to predict which adverse event will be of interest in the future. Adding this process strictly for improving publication seems unnecessary.

The authors briefly mention that full datasets should be published on independent websites. However, this can be done in many ways and placing at the end of section called “identify and communicate most clinically relevant adverse events” does not make one confident that industry will actually adhere to this.

The authors’ goal is to improve credibility of industry sponsored trials. Instead of discouraging statistical testing and changing the existing filters industry should focus on transparency for the benefit of public health. Participants in trials risk their life and health to benefit future patients and their sacrifice can only be justified if the hidden data is shared.

Competing interests: No competing interests

10 October 2016
Jeppe Schroll
Herlev Hospital