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Currently 3111 records
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https://ciane.net/id=1984

Created on : 11 Jul 2006
Modified on : 24 Dec 2008

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Bibliographical entry (without author) :

Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 2005;331:19 (2 July)

Author(s) :

Evelyne Decullier, Véronique Lhéritier, François Chapuis

Year of publication :

2005

URL(s) :

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=…
https://doi.org/10.1136/bmj.38488.385995.8F

Résumé (français)  :

Commentaire dans Prescrire numéro 274

« Essais cliniques en France : trop de résultats non publiés »

Prescrire remarque en effet que « les résultats des essais cliniques restent trop souvent non publiés, surtout s’ils ne confirment pas l’hypothèse des auteurs ».

La revue estime qu’« une plus grande transparence dans ce domaine est indispensable ».

Prescrire aborde une étude publiée en 2005 « sur le devenir d’essais cliniques enregistrés en France en 1994. Six à 8 ans plus tard, 62 % des recherches achevées n’avaient fait l’objet d’aucune publication », remarque la revue.

Prescrire ajoute que « les essais dont les résultats étaient en faveur du médicament étudié avaient 4,6 fois plus de chance d’être publiés que les essais dits «négatifs» » (Decullier E et coll. « Fate of biomedical research protocols and publication bias in France : retrospective cohort study », BMJ 2005 ; 331 : 19-22).

La revue remarque que « ce «biais de publication» donne une idée fausse des résultats de la recherche ».

Prescrire propose de « rendre obligatoire l’enregistrement de tous les essais cliniques et de leur protocole dans un registre international », et de « rendre publics les résultats, «positifs» ou «négatifs» »

Abstract (English)  :

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.

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Keywords :

➡ ethics ; evidence-based medicine/midwifery

Author of this record :

Bernard Bel — 11 Jul 2006

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