Autumn 2014 Workshop: Identifying and Reducing the Effects of Non-Adherence in Clinical Trials
Chairs: Thomas Shiovitz, MD; Earle Bain, MD, PhD
This working group will bring together diverse members of the research community to discuss the nature and impact of non-adherence and to propose specific solutions to detect, account for and reduce non-adherence in clinical trials in the form of a white paper to be published before the end of 2016.
The Autumn workshop will begin with a presentation of key issues in order to stimulate debate and produce a working outline of the 7-8 core issues that will be addressed by the working group. Interested members will be selected to choose one of these core issues to research, either alone or as part of a subgroup, and report back with a written summary and appropriate references.
Examples of these core issues are likely to include (1) The effects of non-adherence on sample size calculations and study success, (2) Statistical and trial design methodologies to account for non-adherence, (3) Biomarkers, PK sampling, subject registries and compliance technologies to detect or reduce non-adherence and (4) Regulatory considerations.