Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)

doi:10.1136/bmj.330.7497.956

BMJ 2005;330:956-958 (23 April), doi:10.1136/bmj.330.7497.956

Education and debate

Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)

Karmela Krle $z$ a-Jeri $c$ , clinical research officer¹, An-Wen Chan, special advisor¹, Kay Dickersin, professor², Ida Sim, associate professor of medicine³, Jeremy Grimshaw, director⁴, Christian Gluud, head of Copenhagen trial unit⁵, for the Ottawa Group

¹ Randomised Controlled Trials Unit, Canadian Institutes of Health Research, Ottawa, 160 Elgin Street, Ottawa ON, K1A 0W9, Canada, ² Department of Community Health, Brown University, Providence, USA, ³ Department of Medicine, University of California, San Francisco, USA, ⁴ Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Canada, ⁵ European Clinical Research Infrastructures Network, Copenhagen University Hospital, Copenhagen, Denmark

Correspondence to: K Krle $z$ a-Jeri $c$ kkrleza-jeric@cihr-irsc.gc.ca

Registering of trials is essential to make sure all resultsare publicly available and that ethical obligations to participantsare met

The first 150 words of the full text of this article appear below.

Introduction

Recent evidence of selective reporting of results has erodedpublic and academic confidence in publications of clinical trials,leading to renewed calls for trial registration.^1-5 The dangersof non-disclosure of trial results, although described for years,sparked an international furore last spring after the publicationof two systematic reviews on the effects of selective serotoninreuptake inhibitors for childhood depression.^1
6 Subsequentlegal proceedings⁷ and policy statements by journal editors,^8
9medical associations,¹⁰ and industry¹¹ have recognised the importanceof trial registration. The rationale for registering trialsis well known (box 1).^12
13 Most importantly, the contributionto social good that justifies research on human participantsis not realised when resulting knowledge remains invisible.

As an interested and neutral party that has been registeringthe trials that it funds,¹⁴ the Canadian Institutes of HealthResearch hosted an open meeting on 4 October 2004 in Ottawa,Canada, to foster international consensus on trial registration.. . . [Full text of this article]

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