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

Rosilyn Gborogen1, Carolee Polek2

  • 1Methodist Hospital Research Institute.

Clinical Journal of Oncology Nursing
|May 22, 2018
PubMed
Abstract

Insights

Clinical trial nurses frequently observe protocol nonadherence. Patients

Area of Science:

  • Clinical research methodology
  • Patient adherence studies

Background:

  • Patient nonadherence to self-administered study medication in oral agent clinical trials can compromise data validity and reliability.
  • Managing protocol fidelity issues is a critical responsibility for clinical research teams.

Purpose of the Study:

  • To determine which group (patients, physicians/principal investigators, nurses, or other personnel) research nurses identify as most responsible for protocol nonadherence.
  • To characterize the primary causes and contributors to nonadherence within each identified group.

Main Methods:

  • A survey of sixty-seven protocol nurses was conducted.
  • The survey comprised nine questions developed from pilot data.
  • Descriptive statistics and ordinal regressions were employed to analyze the data.

Main Results:

  • Over half of participating nurses reported observing clinical trial nonadherence.
  • Nurses identified significant challenges related to physician, patient, and nurse-related factors.
  • Key causes included patient forgetfulness, refusal of study procedures, insufficient caregiver support, and poor team communication.

Conclusions:

  • Patient-related factors, such as forgetfulness and refusal, are significant contributors to nonadherence.
  • Effective communication and collaboration within the research team are crucial for mitigating nonadherence.
  • Addressing these multifactorial issues is essential for maintaining the integrity of clinical trial data.
Keywords:
Assessmentadherenceoral agentspatient-reported outcomesprotocolresearch

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