title: Adjusting for observable selection bias in block randomized trials.
abstract: In this paper, we propose a model-based approach to detect and adjust for observable selection bias in a randomized clinical trial with two treatments and binary outcomes. The proposed method was evaluated using simulations of a randomized block design in which the investigator favoured the experimental treatment by attempting to enroll stronger patients (with greater probability of treatment success) if the probability of the next treatment being experimental was high, and enroll weak patients (with less probability of treatment success) if the probability of the next treatment being experimental was low. The method allows not only testing for the presence of observable selection bias, but also testing for a difference in treatment effects, adjusting for possible selection bias.
authors.affiliation: Department of Biostatistics, The University of North Carolina at Chapel Hill, NC 27599, USA. aivanova@bios.unc.edu
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
authors.forename: Robert C
authors.initials: RC
authors.lastname: Barrier
authors.forename: Vance W
authors.initials: VW
authors.lastname: Berger
mesh_terms: D006801:Humans; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015983:Selection Bias; D016896:Treatment Outcome; D014481:United States