Open AccessClinical and prophylactic trials with assured new treatment for those at greater risk: I. A design proposal.
Author(s) -
Mara Finkelstein,
Bruce Levin,
Herbert Robbins
Publication year - 1996
Publication title -
american journal of public health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.284
H-Index - 264
eISSN - 1541-0048
pISSN - 0090-0036
DOI - 10.2105/ajph.86.5.691
Subject(s) - sine qua non , protocol (science) , medicine , clinical trial , randomized controlled trial , intensive care medicine , food and drug administration , research design , risk analysis (engineering) , actuarial science , alternative medicine , surgery , economics , statistics , law , mathematics , pathology , political science
The accepted sine qua non for estimating the difference in efficacy between a new and a standard treatment is a randomized controlled clinical trial. Yet in some situations it is either practically or ethically impossible to conduct such a trial. For example, patients who are desperately ill may decline to participate when they learn they may not receive the new treatment, especially when that treatment is readily available outside the experimental protocol. Likewise, in a prophylactic trial of a promising vaccine, recruitment of persons at greater risk may falter or fail. Our objective is to demonstrate that a rigorous comparison of treatments may still be attainable.