Article type
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Abstract
Selective reporting of trial results constitutes an important source of bias in systematic reviews. This problem can be mitigated through trial registration and results reporting on public electronic databases. The World Health Organization (WHO) established the International Clinical Trials Registry Platform (http://www.who.int/ictrp) in August 2005 with the primary objective of ensuring that all clinical trials worldwide are uniquely identifiable through a system of public registers, and that a minimum set of results is disclosed.
This presentation will highlight the current policies and progress of the WHO Registry Platform, as well as the technical and practical challenges of implementing global trial registration. WHO Registry Platform policies apply to all research studies that prospectively assign humans to one or more interventions. For a trial to be considered fully registered, all 20 items in the WHO Trial Registration Data Set must be recorded in a national, regional, or international Primary Register that meets acceptable standards for content, technical capabilities, quality assurance, and administration. A WHO Search Portal to identify trials across these registers will be developed to meet the needs of patients, scientists, and other healthcare workers. As a single trial might be registered multiple times, a mechanism must be established to detect and 'deduplicate' such entries. Use of a single data interchange standard would simplify this process. A Universal Trial Reference Number will then be assigned to each globally unique trial. Some stakeholders have argued against immediate disclosure of registered trial data to protect competitively sensitive information. A policy on disclosure timing will soon be finalized to balance the need for timely transparency with the protection of competitive advantage. Finally, global compliance, oversight, and capacity building must be considered in WHO Registry Platform policies, which will be reevaluated and refined periodically as the complex field of trial registration continues to evolve.
This presentation will highlight the current policies and progress of the WHO Registry Platform, as well as the technical and practical challenges of implementing global trial registration. WHO Registry Platform policies apply to all research studies that prospectively assign humans to one or more interventions. For a trial to be considered fully registered, all 20 items in the WHO Trial Registration Data Set must be recorded in a national, regional, or international Primary Register that meets acceptable standards for content, technical capabilities, quality assurance, and administration. A WHO Search Portal to identify trials across these registers will be developed to meet the needs of patients, scientists, and other healthcare workers. As a single trial might be registered multiple times, a mechanism must be established to detect and 'deduplicate' such entries. Use of a single data interchange standard would simplify this process. A Universal Trial Reference Number will then be assigned to each globally unique trial. Some stakeholders have argued against immediate disclosure of registered trial data to protect competitively sensitive information. A policy on disclosure timing will soon be finalized to balance the need for timely transparency with the protection of competitive advantage. Finally, global compliance, oversight, and capacity building must be considered in WHO Registry Platform policies, which will be reevaluated and refined periodically as the complex field of trial registration continues to evolve.