Association of Cardiovascular Trial Registration With Positive Study Findings

Emdin, Connor A.; Odutayo, Ayodele; Hsiao, Allan J.; Shakir, Mubeen; Hopewell, Sally; Rahimi, Kazem; Altman, Douglas G.

doi:10.1001/jamainternmed.2014.6924

Cited by 23 publications

(19 citation statements)

References 4 publications

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“…Two previous studies compared the conclusions of trials by registration status in specific medical areas [ 19 , 20 ]. One found that trials registered before publication and those unregistered were equally likely to reach conclusions favouring new oncology drugs [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Association between trial registration and treatment effect estimates: a meta-epidemiological study

Dechartres

Ravaud

Atal

et al. 2016

BMC Med

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BackgroundTo increase transparency in research, the International Committee of Medical Journal Editors required, in 2005, prospective registration of clinical trials as a condition to publication. However, many trials remain unregistered or retrospectively registered. We aimed to assess the association between trial prospective registration and treatment effect estimates.MethodsThis is a meta-epidemiological study based on all Cochrane reviews published between March 2011 and September 2014 with meta-analyses of a binary outcome including three or more randomised controlled trials published after 2006. We extracted trial general characteristics and results from the Cochrane reviews. For each trial, we searched for registration in the report’s full text, contacted the corresponding author if not reported and searched ClinicalTrials.gov and the International Clinical Trials Registry Platform in case of no response. We classified each trial as prospectively registered (i.e. registered before the start date); retrospectively registered, distinguishing trials registered before and after the primary completion date; and not registered. Treatment effect estimates of prospectively registered and other trials were compared by the ratio of odds ratio (ROR) (ROR <1 indicates larger effects in trials not prospectively registered).ResultsWe identified 67 meta-analyses (322 trials). Overall, 225/322 trials (70 %) were registered, 74 (33 %) prospectively and 142 (63 %) retrospectively; 88 were registered before the primary completion date and 54 after. Unregistered or retrospectively registered trials tended to show larger treatment effect estimates than prospectively registered trials (combined ROR = 0.81, 95 % CI 0.65–1.02, based on 32 contributing meta-analyses). Trials unregistered or registered after the primary completion date tended to show larger treatment effect estimates than those registered before this date (combined ROR = 0.84, 95 % CI 0.71–1.01, based on 43 contributing meta-analyses).ConclusionsLack of trial prospective registration may be associated with larger treatment effect estimates.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-016-0639-x) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Association between trial registration and treatment effect estimates: a meta-epidemiological study

Dechartres

Ravaud

Atal

et al. 2016

BMC Med

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“…3 There is some evidence that trial registration has contributed to an increase in the publication of trials with negative results, thus curbing publication bias related to preferential reporting of positive findings. 10 Several limitations should be noted when interpreting our findings. This study analyzed only trials registered in ClincialTrials.gov; it is possible that there were additional pediatric interventional trials that were not captured in our analysis.…”

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confidence: 87%

“…ClinicalTrials.gov is the most comprehensive database of clinical trials conducted in the United States and internationally, 8,9 and there is evidence suggesting that it has positively influenced the reporting of clinical trials involving human subjects. 10,11 Despite these heightened ethical and legislative mandates, the discontinuation and nonpublication of clinical trials remains common. 12 -17 Pediatric trials may be particularly vulnerable to these outcomes because they face unique challenges in terms of concerns around testing interventions in children and the logistics of recruiting and consenting research subjects in collaboration with parents and caretakers.…”

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confidence: 99%

Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children

2016

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BACKGROUND: Trial discontinuation and nonpublication represent potential waste in research resources and lead to compromises in medical evidence. Pediatric trials may be particularly vulnerable to these outcomes given the challenges encountered in conducting trials in children. We aimed to determine the prevalence of discontinuation and nonpublication of randomized clinical trials (RCTs) conducted in pediatric populations.

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“…Previous studies have suggested that although ICMJE guidance recommends that journals should not publish manuscripts from trials that were not registered or were retrospectively registered, such trials continue to be published in the medical literature, including in high-impact journals. 4 While compliance with ICMJE registration has been investigated in individual specialities such as cardiology 5,6 , no studies to date have reported on adherence to the ICMJE policy within respiratory medicine.…”

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confidence: 99%

A systematic review of clinical trial registration in major respiratory journals 2010–2018

et al. 2018

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Association of Cardiovascular Trial Registration With Positive Study Findings

Cited by 23 publications

References 4 publications

Association between trial registration and treatment effect estimates: a meta-epidemiological study

Association between trial registration and treatment effect estimates: a meta-epidemiological study

Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children

A systematic review of clinical trial registration in major respiratory journals 2010–2018

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