Standardizing clinical study designs for accelerating drug development

Drug Information Journal

Volumn 31, Issue 3, 1997, Pages 655-663

  Donahue, Rape M J ^a   Ruberg, Stephen J ^b  

^a GLAXOSMITHKLINE   (United States)

^b SANOFI   (France)

Author keywords

Clinical trial design; Drug development cost; Drug development process; Drug development time; Standardization

Indexed keywords

ANALGESIC AGENT; ANTICONVULSIVE AGENT; ANTIEMETIC AGENT; ANTIHISTAMINIC AGENT; ANTIMIGRAINE AGENT; CARDIOVASCULAR AGENT; NEUROLEPTIC AGENT;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG INDUSTRY; DRUG RESEARCH; HUMAN; MAXIMUM ALLOWABLE CONCENTRATION; PRIORITY JOURNAL; STANDARD;

EID: 0030751792     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100305     Document Type: Article

References (5)

1. PSI Professional Standards Working Party. Good Statistical Practice in Clinical Reasearch: Guideline Standard Operating Procedures. Drug Inf J. 1994;28:615-627.
2. DiMasi JA. Trends in Drug Development Costs, Times, and Risks. Drug Inf J. 1995;29:375-384.
3. Bolognese JA. Statistical Issues for the Initial Human Safety Study. Proceedings of the Biopharmaceutical Section of the American Statistical Association. 1991; 274-283.
4. O'Quigley J, Pepe M, Fisher L. Continual Reassessment Method: A Practical Design for Phase I Clinical Trials in Cancer. Biometrics. 1990; 46:33-48.
5. Fairies D. Practical Modifications of the Continual Reassessment Method for Phase I Cancer Clinical Trials. J Biopharma Stat. 1994; 4(2): 147-164.