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Decentralized clinical trials (DCTs): A few ethical considerations.
Carlo Petrini1, Chiara Mannelli1, Luciana Riva1
1Bioethics Unit, Istituto Superiore di Sanità, Rome, Italy.
Frontiers in Public Health
|January 2, 2023
Summary
Decentralized clinical trials (DCTs) reduce patient site visits using digital tools. This review explores the ethical considerations and requirements for these innovative, patient-centric research methods.
Area of Science:
- Clinical Research
- Digital Health
- Bioethics
Background:
- Decentralized clinical trials (DCTs) minimize or eliminate the need for patients to visit hospital sites.
- The COVID-19 pandemic accelerated DCT adoption, with 76% of organizations using decentralized techniques.
- DCTs leverage digital tools (e-consent, apps, wearables, ePRO, telemedicine) and home-based or local healthcare settings.
Purpose of the Study:
- To review the ethical implications and requirements of decentralized clinical trials.
- To encourage further bioethical reflection on the rapid growth of DCTs.
Main Methods:
- Literature review of decentralized clinical trials.
- Analysis of ethical considerations and operational requirements.
Main Results:
- DCTs enhance patient accessibility, adaptability, and population diversity.
- Feasibility and quality depend on infrastructure, staff, regulatory frameworks, and partnerships.
- Ethical concerns include patient-provider relationships, data integrity, privacy, and safety.
Conclusions:
- DCTs offer significant benefits but require careful ethical evaluation.
- Ethics Committees (ECs) need adequate tools and regulatory frameworks for DCT assessment.
- Further bioethical discourse is essential to address the complexities of DCTs.
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