Those who design and run clinical trials often worry about medication adherence among trial participants. Nonadherence is a significant concern in all types of clinical trials, from earlier stages of drug development (including pharmacokinetic, pharma-codynamic, dose-finding, and dose optimization studies) to late-stage pivotal trials and post-marketing studies. Medication adherence is often neglected at every phase of drug development and in clinical research. This can and has led to reduced statistical power and incorrect conclusions regarding efficacy and dose-response relationships.
This paper explores the misconception of near-perfect adherence in clinical trials, and the possible consequences of non-adherence. Plus we will explore a new technology digital pill systems–that allows confirmation of medication ingestion at a dose level.