Use and Abuse of Placebo in Clinical Trials
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D I U Information ~ Journal. Vol. 33. pp. 261-264, 1999 Printed in the USA. All rights reserved.
USE AND ABUSE OF PLACEBO IN CLINICAL TRIALS* D. J. LYONS,MD, MSc, FRCPI Irish Medicines Board, Dublin, Ireland
The double blind, placebo controlled clinical trial (PCT) has been for many years the most rigorous and compelling method for demonstrating the efficacy of new therapeutic agents. Despite this, concerns have been expressed in the medical literature that there is misuse of the PCT and that such misuse is being driven by the requirements of the pharmaceutical industry and pharmaceutical regulatory authorities. In this paper a brief general overview of the advantages and disadvantages of the PCT is provided and comments are made on its use for pharmaceutical registration and regulatory purposes. Key Words: Placebo; Clinical trials
INTRODUCTION FOR MANY YEARS, the gold standard for demonstrating the efficacy of new therapeutic agents has been the double blind, placebo controlled clinical trial. Inherent in the conduct of such trials, however, is a conflict between the need to provide the best available care for each patient and the requirement to provide the best care for patients in general. Usually, half the patients participating in a PCT ma1 will be offered a treatment which is designed to have no specific effect on their illness, thus, they cannot directly benefit from the therapeutic intervention which is the subject of the trial. The PCT is the most stringent criterion of efficacy, however, so it is important in the overall treatment of patients to perform such trials, in order to optimize the treatment of future patients.
Terrace, Dublin 2, Ireland.
With increasing availability of effective treatments, the potential for a conflict between individual and group benefits becomes more frequent and more acute. Concerns have been intermittently and increasingly expressed in the medical literature (1,2,3) and more recently, a perception has grown that inappropriate use of placebo is being driven by the requirements of the pharmaceutical industry and pharmaceutical regulatory authorities (45). In this paper the advantages and disadvantages of the use of placebo in clinical trials are reviewed with comment on the influence of regulatory requirements.
ADVANTAGES OF
USE
Assuming correct diagnosis and conventional standards of clinical care, most medical intervention is likely to be therapeutically beneficial, if for no other reason- than the perception of support offered to the patient.
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D. J. Lyons
Thus, in the setting of a clinical trial the overall benefit is the sum of 1. Participation in the trial, 2. Nonspecific benefit of treatment, the placebo effect, and 3. The specific or direct benefit of treatment.
While all are of advantage to the patient the first two act as confounding factors for the investigator attempting to measure the specific benefit of treatment. The placebo
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