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Br Med Bull. 2015;116:43-53. doi: 10.1093/bmb/ldv042. Epub 2015 Oct 21.

Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect.

Author information

1
Charles Perkins Centre and Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia barbara.mintzes@sydney.edu.au.
2
School of Health Policy and Management, York University, York, UK University Health Network, Toronto, Canada Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.
3
Health Action International, Amsterdam, The Netherlands.

Abstract

BACKGROUND:

Although selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive.

SOURCES OF DATA:

Authors' personal files, key documents from Food and Drug Administration and European Medicines Agency and focussed searches of PubMed.

AREAS OF AGREEMENT:

Existing sources of information provide an incomplete overview of scientific research.

AREAS OF CONTROVERSY:

Persistent arguments about commercial confidentiality and the potential difficulties in de-identifying raw data can block important progress. Current industry efforts are voluntary and only partially satisfy the need for complete data.

GROWING POINTS:

Requirements for trial registration are increasing. Important regulatory changes in particular in Europe have the potential to result in the release of more information.

AREAS TIMELY FOR DEVELOPING RESEARCH:

Documenting the effects of prospective trial registration and requirements for proactive clinical trial publication on healthcare decisions, public health and rational resource allocation.

KEYWORDS:

European Medicines Agency; Food and Drug Administration; clinical trial data transparency; pharmaceutical regulation

PMID:
26493102
DOI:
10.1093/bmb/ldv042
[Indexed for MEDLINE]

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