OBJECTIVES: To describe the fate of protocols approved by the French research ethics committees, a national system created by the French 1988 Huriet-Sérusclat Act; to assess publication bias at a national level. DESIGN: Retrospective cohort study. SETTING: Representative sample of 25/48 French research ethics committees in 1994. PROTOCOLS: 649 research protocols approved by committees, with follow-up information. MAIN OUTCOME MEASURES: Protocols' initial characteristics (design, study size, investigator) abstracted from committees' archives; follow-up information (rates of initiation, completion, and publication) obtained from mailed questionnaire to principal investigators. RESULTS: Completed questionnaires were available for 649/976 (69%) protocols. Of these, 581 (90%) studies were initiated, 501/581 (86%) were completed, and 190/501 (38%) were published. Studies with confirmatory results were more likely to be published as scientific papers than were studies with inconclusive results (adjusted odds ratio 4.59, 95% confidence interval 2.21 to 9.54). Moreover, studies with confirmatory results were published more quickly than studies with inconclusive results (hazard ratio 2.48, 1.36 to 4.55). CONCLUSION: At a national level, too many research studies are not completed, and among those completed too many are not published. We suggest capitalising on research ethics committees to register and follow all authorised research on human participants on a systematic and prospective basis.
OBJECTIVES: To describe the fate of protocols approved by the French research ethics committees, a national system created by the French 1988 Huriet-Sérusclat Act; to assess publication bias at a national level. DESIGN: Retrospective cohort study. SETTING: Representative sample of 25/48 French research ethics committees in 1994. PROTOCOLS: 649 research protocols approved by committees, with follow-up information. MAIN OUTCOME MEASURES: Protocols' initial characteristics (design, study size, investigator) abstracted from committees' archives; follow-up information (rates of initiation, completion, and publication) obtained from mailed questionnaire to principal investigators. RESULTS: Completed questionnaires were available for 649/976 (69%) protocols. Of these, 581 (90%) studies were initiated, 501/581 (86%) were completed, and 190/501 (38%) were published. Studies with confirmatory results were more likely to be published as scientific papers than were studies with inconclusive results (adjusted odds ratio 4.59, 95% confidence interval 2.21 to 9.54). Moreover, studies with confirmatory results were published more quickly than studies with inconclusive results (hazard ratio 2.48, 1.36 to 4.55). CONCLUSION: At a national level, too many research studies are not completed, and among those completed too many are not published. We suggest capitalising on research ethics committees to register and follow all authorised research on humanparticipants on a systematic and prospective basis.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Catherine DeAngelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A J P M Overbeke; Torben V Schroeder; Hal C Sox; Martin B Van Der Weyden Journal: Med J Aust Date: 2004-09-20 Impact factor: 7.738
Authors: Louise Berendt; Cecilia Håkansson; Karin F Bach; Per B Andreasen; Lene G Petersen; Elin Andersen; Henrik E Poulsen; Kim Dalhoff Journal: Br J Clin Pharmacol Date: 2010-11 Impact factor: 4.335
Authors: Hiddo J Lambers Heerspink; Mirjam J Knol; Robert J W Tijssen; Thed N van Leeuwen; Diederick E Grobbee; Dick de Zeeuw Journal: Br J Clin Pharmacol Date: 2008-12 Impact factor: 4.335