BMJ Open
 2017
DOI: 10.1136/bmjopen-2017-017917
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Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

Jennifer Miller
1
,
Marc Wilenzick
2
,
Nolan Ritcey
3
et al.

Abstract: ObjectivesTo define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.DesignCross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.Data sourcesData from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Schol… Show more

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Cited by 62 publications

(70 citation statements)
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“…The proportion of trials identified in the present study as sponsored by the biopharmaceutical industry (approximately one-third of all trials) was similar to that reported previously 17 26. In our analysis, the disclosure rate for industry-sponsored studies was similar to that previously observed using TrialsTracker and the EU Clinical Trials Register (EUCTR),22 28 although this rate is lower than the rates reported for newly approved drugs in the USA and Europe,29 30 and either lower than or similar to rates of publication that have been reported by single sponsors,24 25 and with a similar study design profile to a previously reported study 18. Similarly, for non-industry studies, the disclosure rate was similar to that previously seen with TrialsTracker,22 and either lower than or similar to those reported for academic medical centres in the USA and the UK but higher than for EUCTR 18 28 31 32…”
Section: Discussionsupporting
confidence: 88%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
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“…The proportion of trials identified in the present study as sponsored by the biopharmaceutical industry (approximately one-third of all trials) was similar to that reported previously 17 26. In our analysis, the disclosure rate for industry-sponsored studies was similar to that previously observed using TrialsTracker and the EU Clinical Trials Register (EUCTR),22 28 although this rate is lower than the rates reported for newly approved drugs in the USA and Europe,29 30 and either lower than or similar to rates of publication that have been reported by single sponsors,24 25 and with a similar study design profile to a previously reported study 18. Similarly, for non-industry studies, the disclosure rate was similar to that previously seen with TrialsTracker,22 and either lower than or similar to those reported for academic medical centres in the USA and the UK but higher than for EUCTR 18 28 31 32…”
Section: Discussionsupporting
confidence: 88%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
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“…Our study also found that about three quarters of postmarket clinical trials were registered on ClinicalTrials.gov, which is less than previously reported registration rates for clinical trials supporting New Drug Applications 2226. Our finding that about three quarters of the postmarket clinical trials had either reported results or were published is consistent with a recent study by the FDA, which showed that nearly two thirds of postmarket drug interventional clinical trials and other trials designated as “fulfilled” were published in either the scientific literature or on the ClinicalTrials.gov website 16.…”
Section: Discussioncontrasting
confidence: 87%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
“…Our study extended this analysis to the entire clinicaltrials.gov registry (not only randomised trials) and many additional trial properties beyond enrolment size, including reported use of data monitoring committees, duration of the studies, and number of countries. Other previously reported trends confirmed and further examined in this study included lower reporting rate observed for earlier clinical phases and academic sponsors,3839 longer dissemination lag for journal publications,42 and overall improvements in dissemination of results 43…”
Section: Discussionsupporting
confidence: 83%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
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