Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee
Swiss Medical WeeklyPublished 5 April 2008Open access
Erik von Elm, Alexandra Röllin, Anette Blümle
Citations112
SJR quartileQ3
SJR score0.50
SNIP0.53
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Abstract
In this cohort of applications to an ethics committee in Switzerland, only about half of clinical drug trials were published. Large multi-centre trials with non-commercial funding were more likely to be published than other trials, but most trials were funded by industry.
Keywords
Decision SciencesMedicinePharmacology, Toxicology and Pharmaceutics
Psychological BulletinThe file drawer problem and tolerance for null results.
8,595 Citations1979Robert Rosenthal
Quantitative procedures for computing the tolerance for filed and future null results are reported and illustrated, and the implications are discussed.
BMJAssessing the quality of controlled clinical trials
3,334 Citations2001Peter Jüni, Douglas G Altman +1 more
The concept of study quality and the methods used to assess quality are discussed and the methodology for both the assessment of quality and its incorporation into systematic reviews and meta-analysis is discussed.
The LancetPublication bias in clinical research
3,095 Citations1991Philippa Easterbrook, Radha Gopalan +2 more
The presence of publication bias in a cohort of clinical research studies is confirmed and it is suggested that conclusions based only on a review of published data should be interpreted cautiously, especially for observational studies.
Cambridge University Press eBooksEthical principles for medical research involving human subjects
2,605 Citations2003Sue Eckstein
BMJPharmaceutical industry sponsorship and research outcome and quality: systematic review
2,163 Citations2003Joel Lexchin, Lisa A Bero +2 more
Investigating whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support found systematic bias favours products which are made by the company funding the research.
JAMAEmpirical Evidence for Selective Reporting of Outcomes in Randomized Trials
1,806 Citations2004An‐Wen Chan, Asbjørn Hróbjartsson +3 more
The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.
JAMAScope and Impact of Financial Conflicts of Interest in Biomedical Research
1,803 Citations2003Justin E. Bekelman, Yan Li +1 more
Original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research are reviewed to show a statistically significant association between industry sponsorship and pro-industry conclusions.
New England Journal of MedicineClinical Trial Registration: A Statement from the International Committee of Medical Journal Editors
1,211 Citations2004Catherine De Angelis, Jeffrey M. Drazen +11 more
The LancetSelective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data
1,062 Citations2004Craig Whittington, Timothy J. Kendall +4 more
A meta-analysis of data from randomised controlled trials that evaluated an SSRI versus placebo in participants aged 5-18 years and that were published in a peer-reviewed journal or were unpublished and included in a review by the Committee on Safety of Medicines indicated that risks could outweigh benefits of these drugs to treat depression in children and young people.
Cochrane Database of Systematic ReviewsFull publication of results initially presented in abstracts
949 Citations2007Roberta W. Scherer, Patricia Langenberg +1 more
Only 63% of results from abstracts describing randomized or controlled clinical trials are published in full, and 'Positive' results were more frequently published than not 'positive' results.
JAMAFactors Influencing Publication of Research Results
853 Citations1992Kay Dickersin
There was evidence of publication bias in that for both institutional review boards there was an association between results reported to be significant and publication and contrary to popular opinion, publication bias originates primarily with investigators, not journal editors.
BMJPublication bias: evidence of delayed publication in a cohort study of clinical research projects
829 Citations1997Jerome M Stern, R. J. Simes
JAMAAssociation of Funding and Conclusions in Randomized Drug Trials
744 Citations2003Bodil Als‐Nielsen, Wendong Chen +2 more
Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results, and readers should carefully evaluate whether conclusions in randomized trials are supported by data.
BMJEvidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications
639 Citations2003Hans Melander, Jane Ahlqvist-Rastad +2 more
Any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.
JAMAEffect of the Statistical Significance of Results on the Time to Completion and Publication of Randomized Efficacy Trials
629 Citations1998John P. A. Ioannidis
There is a time lag in the publication of negative findings that occurs mostly after the completion of the trial follow-up among randomized efficacy trials.
New England Journal of MedicineConflict of Interest in the Debate over Calcium-Channel Antagonists
620 Citations1998Henry T. Stelfox, Grace Chua +2 more
BMJIdentifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors
611 Citations2005An‐Wen Chan, Douglas G. Altman
Incomplete reporting of outcomes within published articles of randomised trials is common and is associated with statistical non-significance, the medical literature represents a selective and biased subset of study outcomes, and trial protocols should be made publicly available.
JAMAWithholding Research Results in Academic Life Science
583 Citations1997David Blumenthal
Withholding of research results is not a widespread phenomenon among life-science researchers, however, withholding is more common among the most productive and entrepreneurial faculty.
JAMAUnderreporting Research Is Scientific Misconduct
556 Citations1990lain Chalmers
An extended use of prospective registration of trials at inception, as well as benefiting clinical research in other ways, could help people to play their respective roles in reducing underreporting of clinical trials.
The LancetEpidemiology and reporting of randomised trials published in PubMed journals
475 Citations2005An‐Wen Chan, Douglas G. Altman
The epidemiology and reporting of methodological details for all 519 PubMed-indexed randomised trials published in December, 2000 were assessed, and power calculation, primary outcomes, random sequence generation, allocation concealment, and handling of attrition were each adequately described.
Canadian Medical Association JournalOutcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research
446 Citations2004A.-W. Chan
Whether outcome reporting bias would be present in a cohort of government-funded trials subjected to rigorous peer review and whether primary outcomes specified in trial protocols were compared with those reported in publications is compared.
JAMAWhy Review Articles on the Health Effects of Passive Smoking Reach Different Conclusions
430 Citations1998Deborah E. Barnes
The conclusions of review articles on the health effects of passive smoking are strongly associated with the affiliations of their authors, and readers should consider authors' affiliations when deciding how to judge an article's conclusions.
Journal of General Internal MedicineSource of funding and outcome of clinical trials
403 Citations1986Richard A. Davidson
Few trials supported by pharmaceutical manufacturers favored traditional therapy; some reasons for this finding may include selection of drugs likely to be proven efficacious, Type II errors (false-negative studies), and fear of discontinuation of funding should such studies be submitted.
New England Journal of MedicineIs This Clinical Trial Fully Registered? — A Statement from the International Committee of Medical Journal Editors
361 Citations2005Catherine De Angelis, Jeffrey M. Drazen +11 more
PubMedHow important is publication bias? A synthesis of available data.
312 Citations1997Kay Dickersin
This article will review the major evidence available regarding publication bias and will suggest measures for overcoming the problem.
PubMedNIH clinical trials and publication bias.
298 Citations1993Kay Dickersin, Yuan‐I Min
Even when the overall publication rate is high, such as for trials funded by the NIH, publication bias remains a significant problem and more reliable systems for maintaining information about initiated studies are needed.
BMJPrinciples for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
239 Citations2005Karmela Krleža-Jerić, An‐Wen Chan +4 more
An open meeting on 4 October 2004 in Ottawa, Canada, to foster international consensus on trial registration aims to establish internationally recognised principles for registration and highlights and discusses some of the key principles.
Journal of Clinical EpidemiologyBias in meta-analytic research
231 Citations1992David T. Felson
This manuscript reviews specific types of bias which are common at each of the three stages at which bias can be injected into a meta-analysis, finding studies, selection of the identified studies for theMeta-analysis and extraction of data from the selected studies.
JNCI Journal of the National Cancer InstituteSelective Reporting Biases in Cancer Prognostic Factor Studies
230 Citations2005P. Kyzas, Konstantinos T. Loizou +1 more
Selective reporting may spuriously inflate the importance of postulated prognostic factors for various malignancies and meta-analyses thereof should maximize retrieval of information and standardize definitions.
Statistics in MedicineConfronting publication bias: A cohort design for meta‐analysis
219 Citations1987R. J. Simes
A model is developed for pooling the results of clinical trials which is free from publication bias and is illustrated using the International Cancer Research Data Bank (ICRDB) registry of cancer clinical trials to evaluate the effect of chemotherapy on survival in advanced ovarian cancer.
BMC Medical Research MethodologyMore insight into the fate of biomedical meeting abstracts: a systematic review
197 Citations2003Erik von Elm, Michael C. Costanza +2 more
Estimating the proportion of abstracts submitted to meetings that are eventually published as full reports and identifying abstract and meeting characteristics associated with acceptance and publication, using logistic regression analysis, survival-type analysis, and meta-analysis.
JAMABioequivalence of Generic and Brand-name Levothyroxine Products in the Treatment of Hypothyroidism
186 Citations1997Betty J. Dong
The 4 generic and brand-name levothyroxine preparations studied are different but are bioequivalent by current Food and Drug Administration criteria and are interchangeable in the majority of patients receiving thyroxine replacement therapy.
Evaluation & the Health ProfessionsDevelopment of the Cochrane Collaboration’s Central Register of Controlled Clinical Trials
185 Citations2002Kay Dickersin, Eric Manheimer +5 more
The history and methods of CENTRAL, a centralized database of controlled trials and other studies of health care interventions, and the results of an analysis of the current composition are described.
The Journal of Nervous and Mental DiseaseDESIGN AND REPORTING MODIFICATIONS IN INDUSTRY-SPONSORED COMPARATIVE PSYCHOPHARMACOLOGY TRIALS
181 Citations2002Daniel J. Safer
This review of recently published pharmaceutical industry-sponsored comparative psychotropic drug trials aims to classify apparent design and reporting modifications that favor the sponsor’s product into 13 discrete categories.
Journal of Health Politics Policy and LawIndustry-Funded Research and Conflict of Interest: An Analysis of Research Sponsored by the Tobacco Industry Through the Center for Indoor Air Research
175 Citations1996Deborah E. Barnes, Lisa Bero
CIAR's stated mission of funding high-quality, objective research has been compromised by conflict of interest, and at least some of CIAR's projects are being used to promote the tobacco industry's agenda.
BMJFate of biomedical research protocols and publication bias in France: retrospective cohort study
154 Citations2005Évelyne Decullier, Véronique Lhéritier +1 more
Too many research studies are not completed, and among those completed too many are not published, at a national level; capitalising on research ethics committees to register and follow all authorised research on human participants on a systematic and prospective basis.
Environmental Health PerspectivesSource of Funding and Results of Studies of Health Effects of Mobile Phone Use: Systematic Review of Experimental Studies
139 Citations2006Anke Huss, Matthias Egger +3 more
A systematic review of studies of controlled exposure to radiofrequency radiation with health-related outcomes and whether the source of funding is associated with the results of studies examined examined whether the interpretation of results from studies of health effects of radio frequencies should take sponsorship into account.
EpidemiologyAmbient Particulate Matter and Health Effects
126 Citations2005H Ross Anderson, Richard Atkinson +3 more
Evidence for publication bias is present in single-city time-series studies of ambient particles and selection of positive estimates from a range of lags could increase summary estimates for PM10 and daily mortality by up to 130% above those based on nondirectional approaches.
JAMALooking Through a Keyhole at the Tobacco Industry
123 Citations1995Stanton A. Glantz
These documents provide the first look at the inner workings of the tobacco industry during the crucial period in which the scientific case that smoking is addictive and kills smokers solidified.
The LancetRole of a research ethics committee in follow-up and publication of results
103 Citations2003Judit Pich, Xavier Carné +4 more
The recruitment rate was lower than expected, and the results of only 21% of finished clinical trials were published in peer-reviewed journals 3 years after, so RECs should devote more effort and resources to assess public dissemination of results of clinical trials.
BMJDenial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials
102 Citations1995R. Aspinall, Neville W. Goodman
Around 2620 patients in the reviewed studies were denied existing drugs, which, though not completely effective or without side effects, do bring some relief from postoperative nausea and vomiting.
BMJPublication: an ethical imperative
88 Citations1995John Pearn
Without an a priori insistence by institutional ethics committees that there be an intention to publish all medical research involving human subjects, ethics committees cannot routinely be subject to the scrutiny or audit which they themselves demand of researchers.
British Journal of Clinical PharmacologyBias in reporting clinical trials
70 Citations1998A. Bardy
Substantial evidence of selective reporting was detected, since trials with positive outcome resulted more often in submission of final report to regulatory authority than those with inconclusive or negative outcomes.
PLoS MedicineClinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group
55 Citations2005Karmela Krleža-Jerić
Registration of clinical trials is an essential step in ensuring that data from all trials are reported, but there are differing opinions on what registration should include.
PubMedResearch synthesis and dissemination as a bridge to knowledge management: the Cochrane Collaboration.
51 Citations2004Jimmy Volmink, Nandi Siegfried +2 more
The work of the Cochrane Collaboration is set in historical perspective, what a Cochrane review is, initiatives for promoting worldwide dissemination of synthesized information are described, and the need for increased investment in the preparation and maintenance of Cochrane reviews is highlighted.
BMJWaiving confidentiality for the greater good
45 Citations2006An‐Wen Chan, Ross Upshur +4 more
Research protocols are usually kept confidential to protect intellectual and commercial interests, but secrecy can also hide deviations that affect the validity of results and threaten the integrity of medical research.