Objectives:
Update consumers on ongoing efforts to expand trial registration to include results reporting. Facilitate development of a position statement that could be contributed by consumers within the Cochrane Collaboration to local and global authorities formulating reporting policy.
Background:
International attention to trial registration has helped to ensure that the public and those performing systematic reviews are aware of all trials undertaken, and not only those that have been published. The WHO's 20-item minimum reporting of protocol items sets the standard for what should be included in registers. Increasingly, trial registration is including results reporting. For example, in the US, legislation mandates results reporting and specifies that the target audience is the lay public. For the information to be meaningful, consumers must provide input into what results reporting information, available through trials registers and the WHO International Clinical Trials Registry Portal, should look like. Clinicaltrials.gov in the US requires a glossary, results pertaining to primary and secondary outcomes, and adverse events. A key question is whether to incorporate a lay summary. While there are clear benefits to having a non-technical summary, this may also open up the opportunity for "spin".
Workshop agenda:
We will review the current status of key results reporting policies and opportunities for input. We will review and discuss the proposals for how data are to be reported and will facilitate formulation of a draft statement. The draft statement will be circulated for email discussion and finalization after the workshop. Consumer groups associated with the Cochrane Collaboration may decide to contribute the statement to policymakers.