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

Abstract

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...

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

“…The authors suggest that sponsors and journal editors should share similar information to contribute to better understanding of issues and barriers to full transparency. Over the period studied there was no evidence of submission or reporting bias 17 . Zarin et al 11 have proposed a number of actions for various stakeholder groups for improving the trial reporting system over the next decade.…”

“…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 . The authors suggest that sponsors and journal editors should share similar information to contribute to better understanding of issues and barriers to full transparency.…”

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

“…Indeed, there are legitimate inclinations of personal nature that, if undetected, may lead to an unwanted influence. For instance, a finding that is unexpected or novel, or unfavourable to a drug, may be more appealing for publication and may therefore constitute a personal interest of an investigator working in academia …”

“…Secondly, the concept of the “ENCePP Seal,” developed as an option to formalise both the commitment to the Code and the application of ENCePP methodological standards, was often misunderstood as suggesting that some provisions of the Code were optional and would only apply if the Seal was requested. Thirdly, the principle of conflict of interest referred almost exclusively to financial or commercial interests without considering the importance of the influence that institutional or personal interests may have on outcomes of research . And finally, the Code had initially been created before the EU pharmacovigilance legislation came into force in 2012 and experience with the implementation of this meant that clarifications were needed as to how some provisions would apply to postauthorisation safety studies (PASS) .…”

“…Thirdly, the principle of conflict of interest referred almost exclusively to financial or commercial interests without considering the importance of the influence that institutional or personal interests may have on outcomes of research. 5 And finally, the Code had initially been created before the EU pharmacovigilance legislation came into force in 2012 and experience with the implementation of this meant that clarifications were needed as to how some provisions would apply to postauthorisation safety studies (PASS). 6 A major revision of the Code was therefore undertaken in 2017 and completed in 2018.…”