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Medication adherence in clinical trials: missing the forest for the trees
Sanskriti Shukla1, Rohan Tripathi2, Saibal Das3,4
1Translational Health Science and Technology Institute, Faridabad, India.
The International Journal of Pharmacy Practice
|October 16, 2025
Summary
Improving medication adherence measurement in clinical trials is crucial. New tools and strategies can enhance trial validity, reduce costs, and ensure results reflect real-world patient outcomes.
Area of Science:
- Clinical Trials
- Pharmacology
- Health Services Research
Background:
- Medication adherence is critical for clinical trial validity but often poorly measured.
- Nonadherence can introduce bias in efficacy and safety data, inflate trial costs, and compromise regulatory decisions.
Purpose of the Study:
- To review the impact of nonadherence in clinical trials.
- To evaluate traditional self-report methods versus newer adherence measurement tools.
- To highlight strategies for improving medication adherence in research settings.
Main Methods:
- Review of existing literature on medication adherence measurement in clinical trials.
- Discussion of limitations of self-report methods.
- Exploration of advanced technologies such as electronic monitoring, serum drug concentrations, and ingestible sensors.
- Examination of behavioral interventions, digital tools, and trial design modifications.
Main Results:
- Conventional self-report methods for measuring adherence are inadequate.
- Novel tools like electronic monitoring and serum drug concentrations offer more objective measures.
- Behavioral interventions and optimized trial designs show promise for enhancing adherence.
- Standardized reporting frameworks (e.g., EMERGE) require further validation.
Conclusions:
- Comprehensive strategies are needed to improve medication adherence measurement and management in clinical trials.
- Customized approaches considering patient populations and study environments are essential.
- Future research should focus on scalable real-time tracking, predictive modeling, and harmonized definitions for better comparability and decision-making.
- Addressing adherence effectively will improve clinical trial consistency and the generalizability of findings to clinical practice.
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