Access to patient-level trial data

New England Journal of Medicine

Volumn 370, Issue 5, 2014, Pages 485-486

  Barron, Hal ^a   Rosenblatt, Michael ^b  

^a F Hoffmann La Roche Ltd   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; CONSENSUS; DRUG INDUSTRY; DRUG RESEARCH; EUROPEAN UNION; HUMAN; LETTER; PATIENT INFORMATION; PRIORITY JOURNAL; RESPONSIBILITY; TREATMENT RESPONSE; UNITED STATES;

EID: 84893101724     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc1315673     Document Type: Letter

References (4)

1. Eichler H-G, Pétavy F, Pignatti F, Rasi G. Access to patientlevel trial data - a boon to drug developers. N Engl J Med 2013;369:1577-9.
2. Nisen P, Rockhold F. Access to patient-level data from GlaxoSmithKline clinical trials. N Engl J Med 2013;369:475-8.
3. Rawal B, Deane BR. Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in Europe. Curr Med Res Opin 2013 November 11 (Epub ahead of print).
4. EFPIA and PhRMA. Principles for responsible clinical trial data sharing: our commitment to patients and researchers (http://phrma.org/sites/default/ files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf).