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Journal article

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Abstract

INTRODUCTION: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for …

Authors

Pechero G; Pfaff B; Rao M; Pogorzelski D; McKay P; Spicer E; Howe A; Demyanovich HK; Sietsema DL; McTague MF

Journal

Contemporary Clinical Trials Communications, Vol. 22, ,

Publisher

Elsevier

Publication Date

6 2021

DOI

10.1016/j.conctc.2021.100787

ISSN

2451-8654