Significant new reform in the reporting of clinical trial results

24th Aug 2017

Today saw the introduction of a significant new reform in reporting of clinical trial data. BMC Medicine have become the first major medical journal to offer 'Registered Reports' to their users. 

Registered Reports are a publication format in which the research question and the quality of the methodology are peer reviewed before the data are collected and analysed. This format allows methodological issues to be addressed before time and resources are invested in experiments, and helps minimise publication bias and research bias in hypothesis-driven research. In essence, this will facilitate the reporting of both positive and negative results, and help reduce the 'cherry picking' of certain data. 

BMC Medicine outline the steps of this process below: 

The submission and review process for Registered Reports is divided into two distinct stages.

Stage 1 submission: Authors submit manuscripts including only a Background, Methods (including proposed analyses), and Pilot Data (where applicable).

Stage 1 review: Reviewers evaluate study proposals before data are collected, assessing the importance of the research question, feasibility of the methodology, and analysis pipeline.

In principle acceptance (IPA): Manuscripts that pass peer review will be issued an IPA, indicating that the article will be published pending successful completion of the study.

Stage 2 submission: Following study completion, authors submit their finalized manuscript for re-review, now including Results and Discussion sections.

Stage 2 review: Reviewers appraise whether the authors’ adhered to the preregistered experimental procedures and that any conclusions and implications for future research, policy, and practice, are justified given the data.

Registered Reports were adopted by the field of psychology a few years ago and have been taken up by 70 academic journals since. With other initiatives including the drive to make all research open access, it is hoped that this new reform will help make scientific research more transparent and reproducible.

Click here for the full article and press release from BMC Medicine