International standards for Public Reporting of Clinical Trial Outcomes and Results (PROCTOR): a proposal to increase the quality of evidence produced by systematic reviews

Article type
Authors
Krleza-Jeric K, Djubegovic B, Nasser M, Reveiz L, Huic M, Lemmens T, Sim I, Armstrong W, Metz C, Elemam K, Wager E
Abstract
Background: Public disclosure of clinical trial results should facilitate the critical appraisal of trials and thus increase the quality of systematic reviews. Namely, as important as trial registration is, it cannot remove publication bias unless it is complemented by results reporting. It is becoming obvious that public disclosure of results should move beyond publications in peer review journals, and use the opportunities provided by the Internet. Numerous ongoing initiatives and regulations of results reporting (e.g. FDA Amendments Act) are major steps forward but they do not achieve goals of complete transparency. Furthermore, these initiatives are mainly localized, while public reporting of results of clinical trials merits the global approach. However, there are many issues to be solved regarding the public disclosure of results including the scope, purpose, and form. Objectives: To explore issues related to public disclosure of results of clinical trials from perspectives of various constituencies. Methods: An international dialogue on results disclosure of a broad range of equally represented constituencies (including systematic reviewers) was initiated by the Canadian Institutes of Health Research. Following a structured outline, each participant prepared his/her group’s views. One member of each constituency summarized all contributions from his/her group and presented them at the meeting. The discussion that followed did not aim at reaching any consensus but identifying and analysing issues. Results: A number of issues were identified regarding how, when, for whom, and in which ways results of clinical trials should be reported, and how they might be used. Furthermore, the PROCTOR group recommends that international standards for public disclosure of trial results are developed. This will have various implications for Cochrane review authors which will be further reported. Conclusions: Public disclosure of clinical trial results is a logical next step in the process of facilitating the critical appraisal of trials and thus increasing the quality of evidence produced by systematic reviews. International standards for results disclosure are needed to complement the existing international standards for trial registration.