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Mitigating the Effects of Nonadherence in Clinical Trials

Thomas M Shiovitz1,2, Earle E Bain3, David J McCann4

  • 1California Neuroscience Research Medical Group, Sherman Oaks, CA, USA.

Journal of Clinical Pharmacology
|December 5, 2015
PubMed

Insights

Addressing subject nonadherence and inappropriate participants is crucial for clinical trial success. This study recommends statistical analyses, protocol designs, and technologies to mitigate these issues, ensuring reliable trial data.

Area of Science:

  • Clinical trial methodology
  • Pharmacovigilance
  • Biostatistics

Background:

  • Subject nonadherence and inappropriate enrollment negatively impact clinical trial validity.
  • Nonadherence inflates variance, reduces statistical power, and diminishes observed treatment effects.
  • Inappropriate subjects introduce confounding factors affecting safety and efficacy assessments.

Purpose of the Study:

  • To explore and model nonadherence in clinical trials.
  • To provide recommendations for identifying and mitigating nonadherence and inappropriate subject enrollment.
  • To enhance the reliability and integrity of clinical trial data.

Main Methods:

  • Exploration and modeling of nonadherence patterns.
  • Review of existing challenges in subject adherence and eligibility.
  • Development of recommendations for protocol design and data analysis.

Main Results:

  • Nonadherence and inappropriate subjects significantly compromise trial outcomes.
  • Statistical analyses, novel protocols, and adherence technologies are effective mitigation strategies.
  • Biomarkers and subject registries can aid in identifying and managing nonadherence.

Conclusions:

  • Proactive management of subject nonadherence and eligibility is essential for robust clinical trial results.
  • Implementing recommended strategies can improve data quality and trial efficiency.
  • The International Society for CNS Clinical Trial Methodology (ISCTM) provides a framework for addressing these critical issues.
Keywords:
adherenceclinical trialsduplicate subjectsnonadherenceprofessional subjects

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