News from working groups: Clinical Study Reports?

In June 2017 ISDB Committee members and other bulletins interested, participated in a workshop on clinical study reports (CSRs). This two day workshop was organized by the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care, IQWIG) in Cologne, Germany. Beate Wieseler and her colleagues lectured about the framework of these CSRs and we could also practice what we had learned. The participants were very enthusiastic about this experience and the Committee discussed how we could further develop our knowledge. Interestingly, the Cochrane Collaboration was also working on this topic and the Committee and interested members gave input to their proposal on the guidance for including CSR’s in their reviews. On the Cochrane Collaboration’s website the following information was shared ( news/request-comments-draftinterim-guidance-how-decidewhether-incorporate-clinical-studyreports-and-other-regulatorydocuments-cochrane-reviews).

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 Cochrane 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 was coordinated by  (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. Cochrane invited 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.

Meanwhile, Cochrane reported that the final guidance was made up and delivered to the Scientific Committee meeting in February 2018. CSC members agreed this data was important in tackling reporting bias. The report’s findings were accepted in principle by the committee. However, further consideration of roll out and implementation is required within the main body of Cochrane. We wait for the final documents. What will turn out for ISDB in not yet clear. Is this the start of an ISDB-Working Group on Clinical Study Reports? In any case it is a topic for the next General Assembly of ISDB in Paris 2019. We will keep you informed.