A domain independent structured trial register

Article type
Strang N, Boissel JP
Introduction: The Cochrane collaborative review groups (CRG's) build local specialised registers. The Cochrane collaboration also maintains a global bibliographic register that feeds into Medline. Since the early 80's clinical trialists have lobbied for prospective clinical trial registration. This has led to various initiatives with mixed success. Prospective trial registration is the solution of choice to the trial identification problem. Structured trial report information extraction standardises trial report interpretation and the structure increases subsequent search precision. Meta analysis protocols can be partially expressed and standardised as objective search strategies. Geographically dispersed collaborative work is enabled by a shared, centralised resource.

Objective: Our objective is to explore the nature of and develop an information system exploiting a domain independent structured trial register database that is integrated into the Cochrane process.

Methods: Expert trialists' and meta analysts' knowledge was elicited. Protocol writing Standard Operating Procedures, structured abstracts and trial reports, and existing registers were analysed. Reasons for the mixed success of registers to date were studied.

Results: The structure of the Cochrane collaboration is adapted to the supply of information to a central system. A database structure and information coding mechanism and an internet client server solution, based on the prototype software developed in the TriSum project is proposed. Methods to take into account the justifiable reticence of the pharmaceutical industry are proposed.

Discussion: Registration should be both retrospective (hand searching and CRG contributions) and prospective, incorporating trials from their inception. Collaborative working and a mechanism for action by Cochrane fields could be enabled by the system. The system could provide a powerful resource for reviewers, consumers, practitioners, administrators and researchers both within and beyond the Cochrane Collaboration. Our proposals are the basis for discussion.