Testing noninferiority of response rates for regulatory filings using transformations

Drug Information Journal

Volumn 35, Issue 4, 2001, Pages 1165-1171

  Wiens, Brian L ^a   Iglewicz, Boris ^a  

^a AMGEN INC   (United States)

Author keywords

Binomial; Equivalence; Noninferiority; Proportion; Transformation

Indexed keywords

ANTIINFECTIVE AGENT;

ANTIBIOTIC THERAPY; CLINICAL RESEARCH; CLINICAL TRIAL; CONFERENCE PAPER; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; HUMAN; INFECTION; PRIORITY JOURNAL; SAMPLING; TREATMENT FAILURE; TREATMENT OUTCOME;

EID: 0035739145     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500413     Document Type: Conference Paper

References (14)

1. 'Proving the null hypothesis' in clinical trials
2. Clinical equivalence
3. Determining equivalence and the impact of sample size in anti-infective studies: A point to consider
4. Sample size requirements for evaluating a conservative therapy
5. On the use of the ratio or odds ratio of response rates in therapeutic equivalence clinical trials with binary endpoints
6. On testing equivalence of three populations
7. Tests for equivalence or noninferiority between two proportions
8. Some issues in the design and analysis of equivalence trials
9. The number needed to treat: A clinically useful measure of treatment effect
10. The Breslow-Day Test as a Precursor to a Stratified Test of Equivalence