Is this clinical trial fully registered? 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, Harold C.; Weyden, Martin B Van Der

doi:10.1016/s0140-6736(05)66588-9

Cited by 134 publications

(124 citation statements)

References 1 publication

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“…In this inadequate reporting of trials, one positive reporting domain was identified by this study: trial registration, which was reported at a rate of 97.5% by Lancet and 100% by the other three journals. The World Health Organization (WHO), facilitating international collaboration by establishing a clinical trials registry platform [29], and ICMJE’s strict policy of considering trials for publication only if they are registered [30] were likely influences.…”

Section: Discussionmentioning

confidence: 99%

Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

Ghimire

Kyung

Kang

et al. 2012

Trials

129

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Background The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals. Methods A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search. Results We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271), reported the specific objective/hypothesis (72.7%; 197/271), described participant eligibility criteria with settings for data collection (60.9%; 165/271), detailed the interventions for both groups (90.8%; 246/271), and clearly defined the primary outcome (94.8%; 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271) and details of blinding (21.0%; 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3%; 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively. Conclusions These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.

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Section: Discussionmentioning

confidence: 99%

Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

Ghimire

Kyung

Kang

et al. 2012

Trials

129

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“…Since 2005, the International Committee of Medical Journal Editors has required that clinical trials be registered prospectively in an approved registry as a condition of publication. 85 Subsequent legislation in several countries has solidified the mandate for trials included in submissions to regulators, 86 and several government funders require registration of trials as a condition of grant approval. 87,88 But many published trials remain unregistered, retrospectively registered, or registered with poor quality information, in violation of the journals’ policies.…”

Section: Recommendationsmentioning

confidence: 99%

Increasing value and reducing waste: addressing inaccessible research

et al. 2014

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The study protocol, publications, full study report detailing all analyses, and participant-level dataset constitute the main documentation of methods and results for health research. However, journal publications are available for only half of all studies and are plagued by selective reporting of methods and results. The protocol, full study report, and participant-level dataset are rarely available. The quality of information provided in study protocols and reports is variable and often incomplete. Inaccessibility of full information for the vast majority of studies wastes billions of dollars, introduces bias, and has a detrimental impact on patient care and research. To help improve this situation at a systemic level, three main actions are warranted. Firstly, it is important that academic institutions and funders reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Secondly, standards for the content of protocols, full study reports, and data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should implement and enforce policies supporting study registration and availability of journal publications, full study reports, and participant-level datasets.

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“…It met with considerable resistance when first proposed in the late 1990s. However, since then, real progress has been made with trial registration and this initiative was given a massive boost when major journals edited by members of the International Committee of Medical Journal Editors (ICMJE) announced that they would not publish trials unless they had been properly registered at their outset (De Angelis et al , 2004, 2005). One of the major aims of trial registration is to eradicate the twin problems of non-publication and redundant publication, which, together, create publication bias.…”

Section: Good Publication Practice For Pharmaceutical Companiesmentioning

confidence: 99%

What Medical Writing Means To Me

Wager¹

2007

Mens Sana Monogr

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This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing.

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Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors

Cited by 134 publications

References 1 publication

Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

Increasing value and reducing waste: addressing inaccessible research

What Medical Writing Means To Me

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