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ANALYSING NON‐COMPLIANCE IN CLINICAL TRIALS: ETHICAL IMPERATIVE OR MISSION IMPOSSIBLE?
Author(s) -
GOETGHEBEUR ELS J. T.,
SHAPIRO STANLEY H.
Publication year - 1996
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/(sici)1097-0258(19961230)15:24<2813::aid-sim366>3.0.co;2-u
Subject(s) - compliance (psychology) , clinical trial , computer science , medicine , psychology , social psychology
Assuming that a drug is active and different from placebo, a patient's gain or loss is likely to depend on how much of the drug is taken and when. The present paper motivates the ethical imperative of statistical compliance analysis by considering important clinical questions, the advent of more precise compliance measuring instruments and new statistical efforts towards well understood analyses that seek to preserve scientific integrity. An extension of Efron and Feldman's approach is developed which exploits the randomization assumption in combination with structural models. It also generates more promising designs and alternative statistical approaches.