Sharing clinical trial data on patient level: Opportunities and challenges

Biometrical Journal

Volumn 57, Issue 1, 2015, Pages 8-26

  Koenig, Franz ^a   Slattery, Jim ^b   Groves, Trish ^c   Lang, Thomas ^d   Benjamini, Yoav ^e   Day, Simon ^f   Bauer, Peter ^a   Posch, Martin ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c British Medical Journal Technology Assessment Group   (United Kingdom)

^d AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY   (Austria)

^e TEL AVIV UNIVERSITY   (Israel)

^f Clinical Trials Consulting and Training Limited   (United Kingdom)

Author keywords

EMA draft policy 0070; Open access to clinical trial data; Raw data; Secondary research; Transparency; Validation

Indexed keywords

CLINICAL RESEARCH; MEDICAL APPLICATIONS; PUBLISHING;

CLINICAL TRIAL; EUROPEAN MEDICINE AGENCYS DRAFT POLICY/0070; JOURNAL EDITORS; OPEN ACCESS TO CLINICAL TRIAL DATA; OPENACCESS; PHARMACEUTICAL INDUSTRY; RAW DATA; REGULATORY AGENCIES; SECONDARY RESEARCHES; VALIDATION;

DECISION MAKING;

BIOSTATISTICS; CLINICAL TRIAL (TOPIC); HUMAN; INFORMATION DISSEMINATION; POLICY; PROCEDURES; PUBLICATION;

BIOSTATISTICS; CLINICAL TRIALS AS TOPIC; HUMANS; INFORMATION DISSEMINATION; PERIODICALS AS TOPIC; POLICY;

EID: 84920934085     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.201300283     Document Type: Article

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