Overhauling clinical trials

Nature Biotechnology

Volumn 25, Issue 3, 2007, Pages 287-292

  Scott, Christopher Thomas ^a   Baker, Monya ^b  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL ENGINEERING; BIOTECHNOLOGY; HEALTH CARE; PATIENT TREATMENT;

CLINICAL TRIALS; DRUG DEVELOPMENT;

DRUG PRODUCTS;

CLINICAL TRIAL; COST CONTROL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HUMAN; MEDICAL PRACTICE; MEDICAL RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZATION; REVIEW;

CLINICAL TRIALS; COST CONTROL; DRUG APPROVAL; DRUG INDUSTRY; HUMANS; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

POLYOMMATINAE;

EID: 33947136401     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt0307-287     Document Type: Review

References (8)

1. European Medicines Agency (EMEA). Reflection Paper on Methodological Issues in Confirmatory Clinical Trials with Flexible Design and Analysis Plan (EMEA, London, March 2006). http://www.emea.eu.int/pdfs/human/ewp/ 245902en.pdf
2. Emerson, S.S. Issues in the use of adaptive clinical trial designs. Statist. Med. 25, 3270-3296 (2006).
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5. Kaitin, K.I. et al. Fastest drug developers consistently best peers on key performance metrics. Tufts Center for the Study of Drug Development Impact Report 8, (2006).
6. Royall, R.M. Ethics and statistics in randomized clinical trials. Statistical Sci. 6, 52-56 (1991).
7. Dragalin, V. Adaptive trials: classification and terminology. Drug Inform. J. 40, 425-435 (2005).
8. Bartlett, R.H. et al. Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. Pediatrics 76, 476-487 (1985).