Advancing in Silico Clinical Trials for Regulatory Adoption and Innovation

Area of Science:

• Biomedicine and Health Sciences
• Computational Biology
• Medical Technology

Background:

• Healthcare adoption of technological innovations, including information and communication technologies, has historically lagged behind other sectors.
• Computer modeling and simulation are transforming biomedical applications, offering potential to reduce, refine, or replace traditional animal and human clinical trials.

Purpose of the Study:

• To present the current framework for In Silico Clinical Trials (ISCT).
• To discuss the role of in silico medicine research communities.
• To examine the perspectives, barriers, challenges, and opportunities for ISCT adoption.

Main Methods:

• Review of the current ISCT framework and related research communities.
• Analysis of diverse perspectives including research, scientific, clinical, regulatory, standardization, data quality, legal, and ethical considerations.
• Overview of successful ISCT projects, available platforms, and FDA-approved paradigms.

Main Results:

• ISCT enables the creation of virtual populations for safety and efficacy testing of drugs and medical devices.
• The paper details various viewpoints on ISCT, highlighting existing barriers and future opportunities.
• Successful ISCT projects and market-ready platforms are presented, alongside regulatory insights.

Conclusions:

• ISCT holds significant potential to revolutionize drug development and medical device testing by leveraging virtual populations.
• Addressing identified barriers and capitalizing on opportunities is crucial for widespread ISCT adoption in healthcare.
• The presented framework, community roles, and successful examples provide a roadmap for advancing in silico medicine.