Background

Since at least the 1960s, individuals and institutions have endorsed the benefits of trial registration, a system for recording the existence of trials at their inception. There are numerous ethical and scientific reasons for registering trials (see Ottawa Statement). Most importantly, participants in any trial assume potential risks in order to contribute to knowledge; investigators and sponsors are thus ethically bound to make information about the study protocol and results publicly accessible.

As an interested and neutral party that has been registering the trials that it funds, the Canadian Institutes of Health Research hosted an open meeting on 4 October, 2004 in Ottawa, Canada, and invited interested parties to contribute to a plan for trial registration. The assembled group - consisting of interested investigators, consumers, journal editors, policymakers, and industry representatives - discussed a set of guiding principles for the development of trial registers. These principles, refined and agreed to over the subsequent two months by those attending the meeting and others, have been published as the Ottawa Statement, Part 1. Some individuals, although supportive of the Statement, were unable to sign because it might imply a position taken by their organisation. Others were generally supportive, but were concerned that registration of all trials, as opposed to randomised trials only, was too ambitious as a first step. These individuals nevertheless provided valuable feedback at the meeting and during refinement of the Statement.

During 2005, the Ottawa Group, consisting of contributors and signatories to the Statement, held two meetings - on 23 May in Portland, USA during the Annual Meeting of the Society for Clinical Trials; and the second one on 24 October in Melbourne, Australia during the XIII Cochrane Colloquium. At those meetings and subsequent Internet-based discussion, a draft of the Ottawa Statement, Part 2 was developed and posted on this website.

During 2006 the Ottawa Group was consulting broadly to finalise the Ottawa Statement, Part 2 on principles of operationalisation of trial registration. The Group met on 27 October, 2006 in Dublin, Ireland, during the Cochrane Colloquium to focus on results disclosure and developed Part 3 of the Ottawa Statement.

As many of you were not be able to attend the meeting in Dublin, and as some issues merit broader discussion, we are inviting you to use our website and contribute to the development of the Ottawa Statement 3 on principles of implementation of registration and disclosure of trial results.