Rothman KJ, Michels KB.
The continued unethical use of placebo controls. N Engl J Med. 1994; 331:394.-8CrossRef
Agostini A. Placebo and EU Guidelines [Letter]. Lancet. 1995; 310:1710.
Aspinall RL, Goodman NW. Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials. BMJ. 1995; 311:844.-6
Henry D, Hill S. Comparing treatments [Editorial]. BMJ. 1995; 310:1279.
Freedman B, Weijer C, Glass KC. Placebo orthodoxy in clinical research. I: Empirical and methodological myths. J Law Med Ethics. 1996; 24:243.-51
Freedman B, Weijer C, Glass KC. Placebo orthodoxy in clinical research. II: Ethical, legal, and regulatory myths. J Law Med Ethics. 1996; 24:252.-9
Angell M. The ethics of clinical research in the Third World [Editorial]. N Engl J Med. 1997; 337:847.-9
. World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA. 1997; 277:925.-6
World Medical Association. Summary History of the World Medical Association Declaration of Helsinki. Ferney-Voltaire, France: World Medical Association; 1985.
American Medical Association Council on Ethical and Judicial Affairs. The use of placebo controls in clinical trials. Report 2-A-1996. Chicago: American Medical Assoc; 1996.
Grof P, Akhter MI, Campbell M, Gottfries CG, Khan I, Lapierre YD, et al. Clinical Evaluation of Psychotropic Drugs for Psychiatric Disorders: Principles and Proposed Guidelines. WHO Expert Series on Biological Psychiatry. vol 2. Seattle: Hogrefe & Huber; 1993:28-9.
Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organizations of Medical Sciences; 1993.
Ellenberg SS, Temple R. Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Ann Intern Med. 2000; 133:464.-70
Levine RJ. Ethics and Regulation of Clinical Research. 2nd ed. New Haven, CT: Yale Univ Pr; 1986.
Adequate and well-controlled studies. Code of Federal Regulations, 21 Part 314.126. Revised as of 1 April 2000. Washington, DC: U.S. Government Printing Office; 2000.
Temple R. Government viewpoint of clinical trials. Drug Information Journal. 1982; 16:10.-7
Temple R. Difficulties in evaluating positive control trials. Proceedings of the American Statistical Association. 1983; 1-7.
Leber P. Hazards of inference: the active control investigation. Epilepsia. 1989; 30:Suppl 1S57.-63
Lasagna L. Placebos and controlled trials under attack [Editorial]. Eur J Clin Pharmacol. 1979; 15:373.-4
Makuch R, Johnson M. Issues in planning and interpreting active control equivalence studies. J Clin Epidemiol. 1989; 42:503.-11
Modell W, Houde RW. Factors influencing clinical evaluation of drugs with special reference to the double-blind technique. JAMA. 1958; 167:2190.-9
Fleming TR. Treatment evaluation in active control studies. Cancer Treat Rep. 1987; 71:1061.-5
Fleming TR. Evaluation of active control trials in AIDS. J Acquir Immune Defic Syndr. 1990; 3:Suppl 2S82.-7
Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996; 313:36.-9
Temple R. Problems in interpreting active control equivalence trials. Accountability in Research. 1996; 4:267.-75
Dollery CT. A bleak outlook for placebos (and for science) [Editorial]. Eur J Clin Pharmacol. 1979; 15:219.-21
Smith JL. Placebos in clinical trials of peptic ulcer. ACG Committee on FDA-Related Matters. Am J Gastroenterol. 1989; 84:469.-74
Freston JW. Dose-ranging in clinical trials: rationale and proposed use with placebo or positive controls. Am J Gastroenterol. 1986; 81:307.-11
Prien RF. Methods and models for placebo use in pharmacotherapeutic trials. Psychopharmacol Bull. 1988; 24:4.-8
Sachar DB. Placebo-controlled clinical trials in gastroenterology. A position paper of the American College of Gastroenterology. Am J Gastroenterol. 1984; 79:913.-7
Laska EM, Klein DF, Lavori PW, Levine J, Robinson DS. Design issues for the clinical evaluation of psychotropic drugs. Prien RF, Robinson DS Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines. New York: Raven Pr; 1994; 29.-35
Pledger G, Hall DB. Active control equivalence studies: do they address the efficacy issue? Peace KE Statistical Issues in Drug Research and Development. New York: Marcel Dekker; 1990; 226.-38
International Conference on Harmonization: choice of control group in clinical trials. Federal Register. 1999; 64:51767-80.
Sramek JJ, Cutler NR. The use of placebo controls [Letter]. N Engl J Med. 1995; 332:62.
Max MB. Divergent traditions in analgesic clinical trials. Clin Pharmacol Ther. 1994; 56:237.-41
Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis. 1985; 27:335.-71
Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. When placebo controlled trials are essential and equivalence trials are inadequate. BMJ. 1998; 317:875.-80
Temple R. Special study designs: early escape, enrichment, studies in non-responders. Communications in Statistics. 1994; 23:499.-531
Amery W, Dony J. A clinical trial design avoiding undue placebo treatment. J Clin Pharmacol. 1975; 15:674.-9
Blackwelder WC. “Proving the null hypothesis” in clinical trials. Control Clin Trials. 1982; 3:345.-53
Guideline for the format and content of the clinical and statistical sections of new drug applications. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration; 1988.