Oral Agents: Challenges With Self-Administered Medication Adherence in Clinical Trials

Background: In oral agent clinical trials, patients may not be adherent to self-administration of study medication; this nonadherence can affect validity and reliability. Many factors contribute to nonadherence to protocol requirements, and managing patients with fidelity issues is the responsibility of the research team.

Objectives: The aim is to identify which group (patients, physicians/principal investigators, nurses, or other personnel) research nurses report as most responsible for protocol nonadherence and to characterize the most observed causes and contributors to nonadherence within each group.

Methods: Sixty-seven protocol nurses completed a nine-question survey developed from pilot data. Descriptive statistics and ordinal regressions addressed the objectives of the study.

Findings: More than half of the nurses observed clinical trial nonadherence in their practices. Nurses identified challenges regarding physician, patient, and nurse factors. The most frequently identified causes included patients’ forgetfulness, refusal to undergo study procedures, inadequate family or caregiver support to complete study activities, ineffective communication, and collaboration within the research team.