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Fate of biomedical research protocols and publication bias in France: retrospective cohort study

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.38488.385995.8F (Published 30 June 2005) Cite this as: BMJ 2005;331:19
  1. Evelyne Decullier, research fellow1,
  2. Véronique Lhéritier, research assistant2,
  3. François Chapuis (francois.chapuis{at}chu-lyon.fr), senior researcher3
  1. 1 Clinical Research Unit, DIM des Hospices Civils de Lyon, 162 avenue Lacassagne, 69424 Lyon cedex 03, France
  2. 2 CCPPRB Lyon B -Hôpital Hotel-Dieu, place de l'Hopital, 69002 Lyon
  3. 3 French National Confederation of Research Ethics Committees - Hôpital Hotel-Dieu, 69002 Lyon
  1. Correspondence to: F Chapuis
  • Accepted 9 May 2005

Abstract

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.

Footnotes

  • Contributors ED coordinated the study, managed the data, did the statistical analysis, and drafted the manuscript. VL participated in the design of the study, coordinated the study, and managed the data. FC designed, submitted, and coordinated the study, interpreted data, and helped to draft the manuscript.

  • Funding French Ministry of Health (Programme Hospitalier de Recherche Clinique 1998 −065) and Hospices Civils de Lyon. French Ministry of Research and Higher Education and Claude Bernard University. Neither of the funding sources was involved at any stage.

  • Competing interests None declared.

  • Accepted 9 May 2005
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