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Decentralization of Clinical Trials: Opportunities, Risks and Development Paths.
Chiara Crepaldi1, Alessandro Venturi2, Luisa Brogonzoli1
1Fondazione The Bridge.
Studies in Health Technology and Informatics
|June 30, 2023
Summary
The COVID-19 pandemic spurred innovation in clinical trial design, emphasizing decentralized and digital approaches. This study offers feasibility guidelines for decentralized clinical trials in Italy, with broader European relevance.
Area of Science:
- Clinical Research
- Health Policy
- Digital Health
Background:
- The pandemic accelerated the need to update clinical trial research processes.
- There is a growing need to explore new methods for designing and organizing clinical trials.
Purpose of the Study:
- To analyze the implications of decentralization and digitalization in clinical trials.
- To propose feasibility guidelines for decentralized clinical trial protocols in Italy.
Main Methods:
- Literature analysis.
- Multidisciplinary working group collaboration (clinicians, patient representatives, academics, researchers, health policy and digital health experts).
- Confrontation on positive aspects, critical issues, and risks of decentralized and digitalized trials.
Main Results:
- Identified positive aspects, critical issues, and risks associated with decentralized and digitalized clinical trials for various stakeholders.
- Developed proposed feasibility guidelines for decentralized clinical trial protocols specifically for Italy.
Conclusions:
- Decentralized and digitalized clinical trials offer opportunities for research process updates.
- The proposed guidelines and reflections are relevant for Italy and potentially other European countries seeking to implement decentralized trial models.
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