A Cochrane funded (Methods Innovation Fund) project has developed guidance on when to consider regulatory data for inclusion in Cochrane Reviews. Regulatory data includes clinical study reports of trials and other studies, and any other relevant information provided to regulators by trial sponsors. This guidance is interim because we ultimately aim to provide guidance on how to incorporate this type of evidence in Cochrane Reviews to address reporting bias which distorts much of contemporary literature and may affect the conclusions of an unknown number of Cochrane Reviews. This interim guidance includes a rationale, a section explaining the triggers for consideration of regulatory data, the results of a survey relevant to current Cochrane practice, and a planned interactive glossary of regulatory terms. The guidance development project is coordinated by Tom Jefferson (Senior Associate Tutor, University of Oxford, UK) with seven other authors representing CRGs and Methods Groups who expressed an interest in contributing to the project.
WHO AND HOW?
Deadline for survey responses 22nd December 2017
We invite anyone within the Cochrane Community with an interest in addressing reporting bias in studies included in Cochrane Reviews. So, all those working in Cochrane Groups (Centres, Fields, CRGs, Methods), trainers and relevant members of the Central Executive team. Group feedback rather than individual is acceptable should you wish to confer with colleagues. There are two documents (PDF) for participants to review and an excel spreadsheet for comments, please download to complete. Please complete comments sheet by line number. We are not able to the accept any annotated Word or PDF files.
- Interim guidance on how to decide whether to incorporate clinical study reports and other regulatory documents into Cochrane reviews (DRAFT).
- Screenshot gallery. Selected screenshots of regulatory documents.
- Comments sheet.
Email your completed form with your surname in the Reviewer ID worksheet to Tom Jefferson
In the body of your email please provide your full name, email address and Cochrane affiliation stating whether the comments are representing an individual or a Group view.
Once collated, the final guidance will undergo Scientific Committee review for sign off. We will create a short plain language summary available for editorial staff and some of this guidance document will be incorporated into the next version of the Cochrane Handbook for Systematic Reviews of Interventions.
For general enquires about this survey please contact Jackie Chandler, Methods Co-ordinator.