A case study using the PrOACT-URL and BRAT frameworks for structured benefit risk assessment

Biometrical Journal

Volumn 58, Issue 1, 2016, Pages 8-27

  Nixon, Richard ^a   Dierig, Christoph ^b   Mt Isa, Shahrul ^c   Stöckert, Isabelle ^b   Tong, Thaison ^d   Kuhls, Silvia ^b   Hodgson, Gemma ^e   Pears, John ^f   Waddingham, Ed ^c   Hockley, Kimberley ^c   Thomson, Andrew ^g  

^a NOVARTIS PHARMA AG   (Switzerland)

^b BAYER PHARMA AG   (Germany)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

^d UNIVERSITY OF SHEFFIELD   (United Kingdom)

^e Qi Statistics   (United Kingdom)

^f ASTRAZENECA   (United Kingdom)

^g MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

Benefit risk; BRAT; Multicriteria decision analysis; Net clinical benefit; PrOACT URL; Regulatory decision making

Indexed keywords

DECISION MAKING; DECISION THEORY; RISK ANALYSIS;

BENEFIT/RISK; BRAT; CASE-STUDIES; DECISIONS MAKINGS; MULTI-CRITERIA DECISION ANALYSIS; NET CLINICAL BENEFIT; PROACT-URL; REGULATORY DECISION MAKING; REGULATORY DECISIONS; RISKS ASSESSMENTS;

RISK ASSESSMENT;

DECISION SUPPORT SYSTEM; EPIDEMIOLOGY; HUMAN; MULTIPLE SCLEROSIS; PROCEDURES; RISK ASSESSMENT; UNCERTAINTY;

DECISION SUPPORT TECHNIQUES; EPIDEMIOLOGIC METHODS; HUMANS; MULTIPLE SCLEROSIS; RISK ASSESSMENT; UNCERTAINTY;

EID: 84952861671     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.201300248     Document Type: Article

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