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Implementing pharmacogenetics in clinical trials: considerations about current methodological, ethical, and
Irene García-García1,2, Enrique Seco-Meseguer1, Alberto M Borobia1,2
1Clinical Pharmacology Department, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
Expert Review of Clinical Pharmacology
|December 13, 2023
Summary
Integrating pharmacogenetics into clinical trials presents challenges. Clearer guidelines are needed for methodology, sample handling, and data privacy to ensure evidence-based clinical practice.
Area of Science:
- Pharmacogenetics
- Clinical Trials
- Genomic Medicine
Background:
- Pharmacogenetic analysis is increasingly incorporated into clinical trials.
- Significant methodological, ethical, and regulatory hurdles impede its routine clinical application.
- Current integration lacks sufficient evidence and actionable insights for widespread adoption.
Purpose of the Study:
- To review the current state of pharmacogenetics in clinical trials.
- To identify and discuss the challenges associated with its implementation.
- To propose recommendations for addressing these challenges and facilitating integration.
Main Methods:
- Literature review of pharmacogenetics in clinical trials.
- Analysis of applicable regulations and guidelines.
- Assessment of ethics committee application dossiers for pharmacogenetic evaluations.
Main Results:
- Pharmacogenetics integration in clinical trials faces unresolved regulatory, methodological, and ethical issues.
- There is a critical need for transparent guidelines on methodology, sample handling, and data privacy.
- Ensuring participant rights regarding data and sample processing is paramount.
Conclusions:
- Standardized, transparent guidelines are essential for effective pharmacogenetics integration in clinical trials.
- Addressing ethical and regulatory concerns is key to translating trial findings into clinical practice.
- Robust frameworks are needed to protect participant data and ensure informed consent.
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