Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history

Mooney, LaVerne A.; Fay, Lorna

doi:10.1136/bmjopen-2016-012362

Cited by 9 publications

(11 citation statements)

References 26 publications

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“…[5][6][7] Median times to publication were also consistent with previously published figures. [6][7][8][9] When we evaluated the impact of study outcome, first time acceptance rates for studies with positive outcomes were numerically, but not significantly, higher than for those with negative outcomes (56% v 48%). Median time from study completion to submission was 31 days longer for negative than for positive studies and time to publication was 102 days longer, suggesting that greater effort and care (such as journal selection) are required for publication of negative data.…”

Section: Discussionmentioning

confidence: 94%

“…gov and other public sites were eventually published. [3][4][5][6][7][8][9] There has been wide variance across and within sponsor categories (such as industry, academia, government) and by study outcomes (presence versus absence of significance) in both publication rates as well as time to publication, with a general temporal trend toward increased disclosure rates. 3 4 6-12 Studies lacking statistically significant outcomes were less likely to be published and, when they were published, took a longer time from study completion to publication.…”

Section: Introductionmentioning

confidence: 99%

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Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies

Evoniuk

Mansi

deCastro

et al. 2017

BMJ

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Objectives To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals. Design A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor’s policy) to peer reviewed journals within 18 months of study completion—that is, 31 December 2015. In addition, manuscripts from studies completing after 30 June 2014 were included irrespective of outcome if they were submitted before 31 December 2015. Setting Studies conducted by a single industry sponsor (GlaxoSmithKline) Studies reviewed 1064 human drug research studies. Main outcome measures All studies were assigned a publication status at 26 February 2016 including (as applicable): study completion date, date of first primary manuscript submission, number of submissions, journal decision(s), and publication date. All studies were also classified with assessors blinded to publication status as “positive” (perceived favorable outcome for the drug under study), “negative” (perceived unfavorable outcome for the drug under study), mixed, or non-comparative based on the presence and outcome of the primary outcome measure(s) for each study. “Negative” studies included safety studies in which the primary outcome was achieved but was adverse for the drug under study. For the total cohort and each of the four study outcomes, measures included descriptive statistics for study phase, time from study completion to submission and publication, and number and outcome (accepted/rejected) of publication submissions. Results Of the 1064 studies (phase I-IV, interventional and non-interventional) included, 321 had study outcomes classified as positive, 155 as negative, 52 as mixed, and 536 as non-comparative. At the time of publication cut-off date (26 February 2016), 904 (85%) studies had been submitted for publication as full manuscripts and 751 (71%) had been successfully published or accepted, with 100 (9%) still under journal review. An additional 77 (7%) studies were conference abstracts and were not included in submission or publication rates. Submission rates by study outcome were 79% for the 321 studies with positive outcomes, 92% for the 155 with negative outcomes, 94% for the 52 with mixed outcomes, and 85% for the 536 non-comparative studies; while rates of publication at the cut-off date were 66%, 77%, 77%, and 71%, respectively. Median time from study completion to submission was 537 days (interquartile range 396-638 days) and 823 days (650-1063 days) from completion to publication, with similar times observed across study outcomes. First time acceptance rates were 56% for studies with positive outcomes and 48% for studies with negative outcomes. Over 10% of studies across all categories required three or more submissions to achieve successful publication. At the time of ana...

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies

Evoniuk

Mansi

deCastro

et al. 2017

BMJ

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“…18 Some delays may be due to protracted peer review, which is no fault of the investigators. 19 Other delays outside the investigators' control are sponsor termination and contractual issues. 20 Publishing a protocol Publishing a protocol early increases transparency and gives the research community and the public a better idea of ongoing studies.…”

Section: Discussionmentioning

confidence: 99%

Time to publication for publicly funded clinical trials in Australia: an observational study

et al. 2017

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ObjectiveTo examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials.DesignAn observational study using survival analysis.SettingPublicly funded health and medical research in Australia.ParticipantsRandomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010.Main outcome measuresTime from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times.ResultsWe found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89).ConclusionsDespite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding.

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“…For example, 85% (65/76) of Pfizer-sponsored clinical trials for approved products that completed in 2010 were published within 52 months of study completion. However more than 50% required submission to more than one journal to achieve publication, and 21% required three or more attempts 16 . A retrospective review of publication status by study outcome for all human drug research studies conducted by GlaxoSmithKline and completed between 1 January 2009 and 30 June 2014, of which 98% (1041/1064) had results posted on one or more public registries, reported that over 10% of all studies and 13% of those with negative outcomes required three or more submission attempts before they were accepted for publication in peer reviewed medical journals 17 .…”

Section: Discussionmentioning

confidence: 99%

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014

Deane

Porkess

2018

Current Medical Research and Opinion

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Background: The objective of this study was to assess the timely disclosure of results of companysponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. The original study found that over a three-year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies. Methods: The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2014, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2016. Outcome measures and results: The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016. Conclusions: The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2014.

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Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history

Cited by 9 publications

References 26 publications

Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies

Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies

Time to publication for publicly funded clinical trials in Australia: an observational study

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014

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