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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 PLoS+One
2017 ; 12
(5
): e0172581
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Barriers towards the publication of academic drug trials Follow-up of trials
approved by the Danish Medicines Agency
#MMPMID28486523
Berendt L
; Petersen LG
; Bach KF
; Poulsen HE
; Dalhoff K
PLoS One
2017[]; 12
(5
): e0172581
PMID28486523
show ga
OBJECTIVE: To characterize and quantify barriers towards the publication of
academic drug trials. STUDY DESIGN: We identified academic drug trials approved
during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a
survey among the trial sponsors to describe the rates of initiation, completion,
and publication, and the reasons for the failure to reach each of these
milestones. Information on size and methodological characteristics of the trials
was extracted from the EudraCT database, a prospective register of all approved
clinical drug trials submitted to European medicines agencies since 2004.
RESULTS: A total of 181 academic drug trials were eligible for inclusion, 139 of
which participated in our survey (response rate: 77%). Follow-up time ranged from
5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI
65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95%
CI: 89-97%) respectively. The publication rate of completed trials was 73% (95%
CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to
publication 2.9 vs. 3.1 years, p = 0.0412). CONCLUSIONS: Many academic drug
trials are left unpublished. Main barriers towards publication were related to
the process from completion to publication. Hence, there is much to gain by
facilitating the process from analysis to publication. Research institutions and
funders should actively influence this process, e.g. by requiring the publication
of trial results within a given time after completion.