Title
Ethical issues in stopping randomized trials early because of apparent benefit
Date Issued
05 June 2007
Access level
metadata only access
Resource Type
review
Author(s)
Mueller P.
Bassler D.
Koenig B.
Guyatt G.
Mayo Clinic
Publisher(s)
American College of Physicians
Abstract
Stopping randomized trials early because of an apparent benefit is becoming more common. To protect and promote the interests of trial participants, investigators may feel obligated to stop a trial early because of the apparent benefit of a study treatment (compared with placebo or other treatment). There are, however, serious ethical problems with doing so. Truncated trials systematically overestimate treatment effects; in cases where the number of accrued outcome events is small, the overestimation may be very large. Generating seriously inflated estimates of treatment effect violates the ethical research requirement of scientific validity. Subsequent use of inflated estimates to inform clinical decision making and practice guidelines violates the ethical requirements of social value and a favorable risk-benefit ratio. Researchers should ensure that a large number of outcome events accrues before stopping a trial and then continue recruitment to assess whether positive trends continue. This can balance the need to protect research participants with the ethical requirements of scientific validity, social value, and a favorable risk-benefit ratio. © 2007 American College of Physicians.
Start page
878
End page
881
Volume
146
Issue
12
Language
English
OCDE Knowledge area
Ética relacionada con la biotecnología médica
Scopus EID
2-s2.0-34347375380
PubMed ID
Source
Annals of Internal Medicine
ISSN of the container
00034819
Sources of information: Directorio de Producción Científica Scopus