Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect.
BACKGROUND
Although selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive.


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


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


RESULTS
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.


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


CONCLUSIONS
Documenting the effects of prospective trial registration and requirements for proactive clinical trial publication on healthcare decisions, public health and rational resource allocation.
Charles Perkins Centre and Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia barbara.mintzes@sydney.edu.au.
Barbara
B
Mintzes
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.
Joel
J
Lexchin
Health Action International, Amsterdam, The Netherlands.
Ancella Santos
AS
Quintano
D022126:Access to Information; D035843:Biomedical Research / Q000379:methods / Q000639:trends; D002986:Clinical Trials as Topic / Q000592:standards*; D003219:Confidentiality; D004345:Drug Industry / Q000592:standards; D004358:Drug Therapy; D019317:Evidence-Based Medicine / Q000592:standards*; D006801:Humans; D033181:Information Dissemination; D017594:Publication Bias
European Medicines Agency; Food and Drug Administration; clinical trial data transparency; pharmaceutical regulation