In Silico Clinical Trials in Drug Development: A Systematic Review

Area of Science:

• Computational biology
• Clinical research methodology
• Drug development

Background:

• Computational models, specifically in silico clinical trials (ISCTs), are increasingly utilized in medical research.
• In silico methods, also known as model-informed drug development (MIDD), are gaining traction in drug discovery and development.

Conclusions:

• ISCTs are not yet commonly integrated into registered clinical trials and are often disease-specific.
• Limited reproducibility due to lack of open-source models and accessible synthetic data restricts the full exploitation of ISCT benefits.
• Further efforts are needed to enhance the integration, standardization, and accessibility of ISCTs in clinical research and drug development.