One large, well-designed, multicenter study as an alternative to the usual FDA paradigm

Drug Information Journal

Volumn 33, Issue 1, 1999, Pages 265-271

  Fisher, Lloyd D ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

FDA two study paradigm; One large study; Replicating results; Significance level; Strength of evidence

Indexed keywords

DRUG VEHICLE; NEW DRUG; PODOPHYLLOTOXIN;

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONDYLOMA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG APPROVAL; DRUG EFFECT; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GEL; HUMAN; LICENCE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; TOPICAL DRUG ADMINISTRATION;

EID: 0033004552     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159903300130     Document Type: Article

References (5)

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3. Tyring SD, Edwards L, Cherry LK, Ramsdell WM, Kotner S, Greenberg MD, Vance JC, Barnum G, Dromgoole S, Killey FP, Toter T. Safety and efficacy of 0.5% Podofilox Gel in the treatment of anogenital warts: A double-blind, vehicle-controlled study. Arch Dermatol. 1998.
4. Fisher LD. The use of one-sided tests in drug trials: An FDA advisory committee member's perspective. J Pharm Stat. 1991;1:151-156.
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