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2017 ; 357
(ä): j1726
Nephropedia Template TP
gab.com Text
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English Wikipedia
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
#MMPMID28432051
Evoniuk G
; Mansi B
; DeCastro B
; Sykes J
BMJ
2017[Apr]; 357
(ä): j1726
PMID28432051
show ga
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 analysis, 83
studies had not been submitted for publication, including 49 bioequivalence
studies with positive outcomes and 33 non-comparative studies. Most studies (98%,
1041/1064) had results posted to one or more public registers, including all
studies subject to FDAAA (Food and Drug Administration Amendments Act)
requirements for posting to www.clinicaltrials.govConclusions Over the period
studied, there was no evidence of submission or publication bias: 92% of studies
with negative outcomes were submitted for publication by the cut-off date versus
79% of those with positive outcomes. Publication rates were slightly higher for
studies with a negative (that is, unfavorable) outcome compared with a positive
outcome, despite a slightly lower rate of acceptance at first submission. Many
studies required multiple submission attempts before they were accepted for
publication. Analyses focusing solely on publication rates do not take into
account unsuccessful efforts to publish. Sponsors and journal editors should
share similar information to contribute to better understanding of issues and
barriers to full transparency.
|*Clinical Studies as Topic/statistics & numerical data
[MESH]
|*Peer Review, Research
[MESH]
|*Periodicals as Topic/statistics & numerical data
[MESH]
|*Publication Bias/statistics & numerical data
[MESH]