Access to patient-level data from GlaxoSmithKline clinical trials.

GlaxoSmithKline is providing access to patient-level clinical trial data under a new policy. This article reviews the data-access plan.

[1]  C. Pusey,et al.  Issues in trial design for ANCA-associated and large-vessel vasculitis , 2014, Nature Reviews Rheumatology.

[2]  D. Perera,et al.  Patient-level data: a paradigm shift in clinical trial transparency? , 2013 .

[3]  M. Herder.  Toward a Jurisprudence of Drug Regulation , 2014, Journal of Law, Medicine & Ethics.

[4]  Minna Allarakhia.  The successes and challenges of open-source biopharmaceutical innovation , 2014, Expert opinion on drug discovery.

[5]  M Ferri,et al.  Preparing for responsible sharing of clinical trial data. , 2014 .

[6]  R. Anziano,et al.  Perspectives on clinical trial data transparency and disclosure. , 2014, Contemporary clinical trials.

[7]  Arthur L. Caplan,et al.  Time to ensure that clinical trial appropriate results are actually published , 2013, European Journal of Clinical Pharmacology.

[8]  Bartha M. Knoppers,et al.  Data sharing, year 1--access to data from industry-sponsored clinical trials. , 2014, The New England journal of medicine.

[9]  Y. Benjamini,et al.  Sharing clinical trial data on patient level: Opportunities and challenges , 2014, Biometrical journal. Biometrische Zeitschrift.

[10]  Harlan M Krumholz,et al.  Increasing value and reducing waste: addressing inaccessible research , 2014, The Lancet.

[11]  Participant-level data and the new frontier in trial transparency. , 2013, The New England journal of medicine.

[12]  A. Banerjee,et al.  The Health Impact Fund , 2010, The Lancet.

[13]  Karen Wells,et al.  Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach. , 2014, Pharmaceutical statistics.

[14]  M. Ferri,et al.  Access to Patient-Level Trial Data , 2014 .

[15]  K. Outterson.  Clinical Trial Transparency - Antidote to Weaker Off-Label-Promotion Rules? , 2014, The New England journal of medicine.

[16]  S. Goodman,et al.  Raw data from clinical trials: within reach? , 2013, Trends in pharmacological sciences.