The risks of methodology aversion in drug regulation

Nature Reviews Drug Discovery

Volumn 13, Issue 5, 2014, Pages 317-318

  Bauer, Peter ^a   König, Franz ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; CLINICAL TRIAL (TOPIC); DRUG CONTROL; DRUG SURVEILLANCE PROGRAM; EUROPEAN MEDICINES AGENCY; HEALTH CARE DELIVERY; HEALTH CARE ORGANIZATION; HEALTH CARE PLANNING; HEALTH CARE POLICY; HEALTH SERVICES RESEARCH; NOTE; ORGANIZATIONAL DEVELOPMENT; ORGANIZATIONAL STRUCTURE; POLITICAL PARTICIPATION; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; PUBLICATION; QUANTITATIVE STUDY; RISK BENEFIT ANALYSIS; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; EUROPE; HUMANS; MODELS, STATISTICAL;

EID: 84899636600     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd4319     Document Type: Note

References (5)

1. Eichler, H. G. et al. The risks of risk aversion in drug regulation. Nature Rev. Drug Discov. 12, 907-916 (2013).
2. Skovlund, E. Statisticians in European regulatory agencies. Pharm. Stat. 8, 259-263 (2009).
3. Manolis, E. et al. Role of modeling and simulation in pediatric investigation plans. Paediatr. Anaesth. 21, 214-221 (2011).
4. Gerlinger, C. et al. Considerations on what constitutes a 'qualified statistician' in regulatory guidelines. Stat. Med. 31, 1303-1305 (2012).
5. Eichler, H.-G., Hemmings, R. J. & Vamvakas, S. Where statisticians can contribute to address future challenges for drug regulatory agencies: a view from the European Medicines Agency (EMEA). Stat. Biopharm. Res. 2, 355-358 (2010).