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BMJ Open. 2017 Dec 5;7(12):e017917. doi: 10.1136/bmjopen-2017-017917.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

Author information

1
Division of Medical Ethics, Department of Population Health, NYU School of Medicine, New York, USA.
2
Bioethics International, New York, USA.
3
International Aids Vaccine Initiative, New York, USA.
4
Section of General Internal Medicine and Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
5
Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut, USA.
6
Center for Outcomes Research and Evaluation, Yale-New Haven Health, New Haven, Connecticut, USA.
7
Stanford Law School and the Department of Health Research and Policy, Stanford University Stanford Law School, Stanford, California, USA.

Abstract

OBJECTIVES:

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.

DESIGN:

Cross-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 SOURCES:

Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers.

OUTCOME MEASURES:

Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level.

RESULTS:

The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries.

CONCLUSIONS:

Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress.

KEYWORDS:

bioethics; clinical pharmacology; clinical trial transparency; good pharma scorecard; health Policy; law (see medical law); medical ethics; pharma ethics; public health

PMID:
29208616
PMCID:
PMC5728266
DOI:
10.1136/bmjopen-2017-017917
[Indexed for MEDLINE]
Free PMC Article

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