Using clinical trial regulatory documents has potential to change the future of Cochrane reviews. These traditionallly rely on data extracted from journal publications, which may be biased. This special session will outline why it is important to think beyond journal publications, present examples of systematic reviews including data from clinical study reports and other regulatory documents and will consider the challenges and opportunities of using this source of evidence in Cochrane reviews. It will provide an opportunity to debate our cross-methods group initiative to develop interim guidance on when to incorporate regulatory documents into Cochrane reviews.

Chair: Su Golder, Co-convenor Cochrane Adverse Effects Methods Group.
“Unpublished data is difficult and time-consuming to identify, obtain, and incorporate into systematic reviews and at the same time we are pressured into producing more rapid reviews. Yet if we don't include unpublished data we can get different results, which will impact on the lives of patients”

Speakers:

Carol Lefebvre, Co-Convenor – Cochrane Information Retrieval Methods Group
“From an information retrieval perspective, identifying studies solely through CSRs (rather than through published articles and other unpublished sources such as trials registers) is a major step change in Cochrane, so it is essential to ascertain for which reviews this approach might be necessary”

Isabelle Boutron, Co-convenor of the bias methods group
“Regulatory documents can be essential to limit reporting bias. However, their use is complex. Clear guidelines on when to use them are clearly needed”.

Tom Jefferson, Cochrane Acute Respiratory Group
“The media talk about regulatory and pharmaceutical data, but few know what this means. The presentation will describe the purpose, size and content of each type of regulatory document which could provide information for inclusion in a Cochrane review including Clinical Study Reports and other regulatory documentation.”

Carl Heneghan, Cochrane Acute Respiratory Group
“The current system of producing systematic reviews typically ignores unpublished trial data, and journals publications only partially report adverse event data: inclusion of clinical study reports and individual patient data will lead to more robust and informative reviews that will ultimately aid clinical decision making”. 

Lesley Stewart, Co-Convenor IPD Meta-analysis Methods Group
“Regulatory documents include richer data than are generally available in journal publications, offering potential to include unpublished studies and unpublished outcomes in reviews, and to scrutinise data and original analyses more carefully. From an IPD perspective, developing reliable approaches to accessing regulatory information also takes us a step closer to being able to more readily access and use IPD from industry sponsored clinical trials (which a number of agencies and companies are working towards as part of their transparency and sharing initiatives). This could be a real game changer for Cochrane reviews.”