Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors

Angelis, Catherine De; Drazen, Jeffrey M.; Frizelle, Frank; Haug, Charlotte; Hoey, John; Horton, Richard; Kotzin, Sheldon; Lainé, Christine; Marušić, Ana; Overbeke, A. John P.M.; Schroeder, Torben V.; Sox, Hal C.; Weyden, Martin B Van Der

doi:10.1056/nejme048225

Cited by 980 publications

(481 citation statements)

References 26 publications

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“…This period includes time both before and after September 13, 2005, the date of implementation of the International Committee of Medical Journal Editors (ICMJE) policy requiring the registration of clinical trials as a prerequisite for consideration for publication. 7,8 …”

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confidence: 99%

Trial Registration at ClinicalTrials.gov between May and October 2005

2005

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BACKGROUND-Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication.

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confidence: 99%

Trial Registration at ClinicalTrials.gov between May and October 2005

2005

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“…24 However, only 26 (11.3%) journals in this research recommended authors to register, and 23 (of 26) journals recommended authors to follow CONSORT guidelines. Li et al 25 surveyed the instructions for authors of 200 highimpact medical journals in China and found that neither the CONSORT Statement, nor the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM) developed by the ICMJE were frequently mentioned.…”

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confidence: 78%

The ethical issues in instructions for authors of Chinese biomedical journals

Yang

Zou

2015

Learned Publishing

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ABSTRACT229 Chinese‐language biomedical journals from A Guide to The Core Journals of China were investigated for their guidance on 14 ethical issues. The issues of authorship, duplicate submission, privacy and confidentiality, and integrity of the data were mentioned in more than 50% of the journals. Except for the issues of authorship and protection of animals in research, significant differences were found between Chinese Medical Association Publishing House (CMAPH) journals (n = 67) and non‐CMAPH journals (n = 162) (P < 0.05). 66 of the 229 journals did not update their instructions for authors regularly. 196 journal instructions listed authorship criteria, while the other 33 did not. Clinical trial registration policy was required by 26 (11.3%) journals, among which the CONSORT statement for randomized trials was required by 23, and only one journal guided the authors to work in line with the EQUATOR Network. The study concludes that the situation of publishing ethics in the instructions for authors of Chinese biomedical journals is not favorable, and that Chinese biomedical editors should learn more about publishing ethics in order to reduce opportunities for publication problems.

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“…4 Des milliers d'études y ont rapidement été enregistrées, mais ce n'était pas le cas pour la majorité des essais. En 2004, l'enregistrement des essais cliniques a été approuvé par l'International Committee of Medical Journal Editors (ICMJE).…”

Section: L'enregistrement Des Essais Cliniques Est-il Chose Courante?unclassified

“…En 2004, l'enregistrement des essais cliniques a été approuvé par l'International Committee of Medical Journal Editors (ICMJE). 4 En plus d'approuver une telle mesure, les revues membres de l'ICMJE ont rendu l'enregistrement prospectif obligatoire pour tous les essais cliniques pour lesquels les participants étaient recrutés après le 1 er juillet 2005. 4 Plusieurs autres revues ont aussi appuyé l'enregistrement des essais cliniques, si bien que le nombre d'essais enregistrés a rapidement augmenté.…”

Section: L'enregistrement Des Essais Cliniques Est-il Chose Courante?unclassified

“…4 En plus d'approuver une telle mesure, les revues membres de l'ICMJE ont rendu l'enregistrement prospectif obligatoire pour tous les essais cliniques pour lesquels les participants étaient recrutés après le 1 er juillet 2005. 4 Plusieurs autres revues ont aussi appuyé l'enregistrement des essais cliniques, si bien que le nombre d'essais enregistrés a rapidement augmenté. 5 Depuis, plusieurs organismes ont signifié leur appui à l'enregistrement.…”

Section: L'enregistrement Des Essais Cliniques Est-il Chose Courante?unclassified

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