Medication adherence assessment in a clinical trial with centralized follow-up and direct-to-patient drug shipments.

ABSTRACT:

Background

Assessment of adherence to study medications is a common challenge in clinical research. Counting unused study medication is the predominant method by which adherence is assessed in outpatient clinical trials but it has limitations that include questionable validity and burdens on research personnel.

Purpose

To compare capsule counts, patient questionnaire responses, and plasma drug levels as methods of determining adherence in a clinical trial that had 2056 participants and used centralized drug distribution and patient follow-up.

Methods

Capsule counts from study medication bottles returned by participants and responses to questions regarding adherence during quarterly telephone interviews were averaged and compared. Both measures were compared to plasma

SUBMITTER: Warren SR 

PROVIDER: S-EPMC6178218 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature