Systematic review protocol assessing the processes for linking clinical trial registries and their published results

INTRODUCTION: Clinical trial registries are an important source of information for tracking clinical trials from their inception through to their reporting, and have been used to measure publication bias and outcome reporting bias. Our aim is to survey and quantify the processes that have been used to identify links between clinical trial registries and published trial reports in studies that rely on these links to evaluate the completeness and accuracy of trial reporting. METHODS AND ANALYSIS: We will identify studies that describe a process for identifying the links between a trial registry included in the WHO International Clinical Trial Registry Platform and published trial results, and use those links to evaluate the completeness and accuracy of trial reporting. Information extracted from the studies will include the purpose and application domain of the study, registries used or searched, processes by which the links were identified, the study period and proportions for which links were found. We will summarise what is known about the number and availability of links between clinical trial registries and published results, and examine how automatic linking, inference and inquiry processes have been used to identify links since the introduction of trial registries. ETHICS AND DISSEMINATION: The systematic review is focused on the analysis of secondary data and does not require ethics approval. The results of the systematic review will be used to inform standard processes used to identify links to and from clinical trial registries in studies that evaluate the completeness and accuracy of clinical trial reports, as well as systematic reviews. Our findings will be disseminated by publishing the systematic review in a peer-reviewed journal, and by engaging with stakeholders from clinical trial registries and bibliographic databases.