Problems in interpreting active control equivalence trials

Accountability in Research

Volumn 4, Issue 3-4, 1996, Pages 267-275

  Temple, Robert ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; PLACEBO;

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CONTROL GROUP; HUMAN; HUMAN EXPERIMENT; METHODOLOGY; RANDOMIZATION; RESEARCH;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CONTROL GROUPS; HUMAN EXPERIMENTATION; HUMANS; PHARMACEUTICAL PREPARATIONS; PLACEBOS; RANDOM ALLOCATION; RESEARCH; RESEARCH DESIGN; THERAPEUTIC HUMAN EXPERIMENTATION;

EID: 0030367916     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989629608573887     Document Type: Article

References (9)

1. Freston, J. (1986) Dose-ranging in clinical trials: rationale and proposed use with placebo or active controls. American Journal of Gastroenterology 81(5):307-311.
2. Glassner, S.P., Clark, P.I., Lipicky, R.J., Hubbard, J.M., and Yusuf, S. (1991) Exposing patients with chronic, stable, exertional angina to placebo periods in drug trials. Journal of the American Medical Association 265(12):1550-1554.
3. Gram, L.F. (1994) Fluoxetine. New England Journal of Medicine 331(20):1354-1361.
4. Lasagna, L. (1979) Editorial: placebos and controlled trials under attack. British Journal of Clinical Pharmacology 15(6):373-374.
5. Prien, R.F. (1988) Methods and models for placebo use in pharmacotherapeutic trials. Psychopharmacology Bulletin 24(l):4-8.
6. Rothman, K.J., and Michels, K.B. (1994) The continued unethical use of placebo controls. New England Journal of Medicine 331(6):394-398.
7. Temple, R. (1982) Government viewpoint of clinical trials. Drug Information Journal Jan/June:10-17.
8. Temple, R. (1983) Difficulties in evaluating positive control trials. Proceedings of the American Statistical Association, Biopharmaceutical Section, 1-7.
9. Temple, R. (1994) Special study designs: early escape, enrichment, studies in non-responders. Communications in Statistics 23(2):499-531.