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Clinical Trials and Machine Learning: Regulatory Approach Review
Diego Alejandro Dri1, Maurizio Massella1, Donatella Gramaglia1
1Clinical Trials Office, Italian Medicines Agency (AIFA), Rome,Italy.
Reviews on Recent Clinical Trials
|July 16, 2021
Summary
Machine Learning (ML) and Artificial Intelligence (AI) are transforming drug discovery and clinical trials. This review examines regulatory approaches and proposes six actions for regulators to ensure patient safety and treatment access.
Area of Science:
- Biomedical Informatics
- Regulatory Science
- Artificial Intelligence
Background:
- Machine Learning (ML) and Artificial Intelligence (AI) are increasingly integrated into drug discovery and clinical development.
- The growing use of ML/AI in clinical trials presents new challenges for regulatory assessment by National Competent Authorities.
- Existing regulatory frameworks are adapting to evaluate trials involving ML/AI technologies.
Purpose of the Study:
- To review the current regulatory landscape for clinical trials utilizing ML and AI.
- To provide insights and actionable proposals for regulatory bodies.
- To foster a robust regulatory framework that ensures patient safety and facilitates access to novel treatments.
Main Methods:
- Systematic review of current regulatory information and guidelines.
- Analysis of the impact of ML/AI on clinical trial design, management, and data generation.
- Development of regulatory recommendations based on identified challenges and opportunities.
Main Results:
- The assessment of clinical trials involving ML/AI is evolving.
- There is a need for proactive regulatory strategies to manage the integration of these technologies.
- Six actionable proposals are presented to guide regulators.
Conclusions:
- ML and AI offer significant potential for advancing drug discovery and clinical development.
- A proactive and adaptive regulatory approach is crucial for harnessing the benefits of ML/AI while safeguarding patients.
- Implementing the proposed regulatory actions can help shape the future of clinical trials.
Keywords:
Artificial intelligencebig dataclinical trialsdigital medicinedrug discoverymachine learningregulatory.More Related Videos
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