Optimizing drug development in oncology by clinical trial simulation: Why and how?

Area of Science:

• Pharmacokinetics and Pharmacodynamics
• In Silico Medicine
• Drug Development

Background:

• Pharmaceutical product development relies heavily on extensive and costly preclinical and clinical trials.
• Computer modeling and clinical trial simulation (CTS) are recognized but underutilized methods in therapeutic research.
• Regulatory bodies like the FDA and EMA acknowledge the potential of these in silico methods.

Purpose of the Study:

• To highlight the potential of clinical trial simulation (CTS) to reduce reliance on animal and human testing.
• To discuss the barriers and facilitators for the broader implementation of CTS in drug development.
• To explore how CTS can advance the P4 medicine paradigm: predictive, preventive, personalized, and participatory.

Main Methods:

• Review of the current role and potential of computer modeling and CTS in pharmacokinetics and pharmacodynamics.
• Identification of technical, legal, and policy issues related to data sharing and integration for CTS.
• Discussion of the necessary advancements in bioinformatics tools and legal frameworks for CTS generalization.

Main Results:

• CTS methods are well-established in pharmacokinetics and pharmacodynamics but are underutilized for drug approval.
• Generalization of CTS is hindered by challenges in data sharing, integration, and the need for specialized software.
• Successful implementation requires bioinformatics tools for data integration and a legal framework for patient privacy.

Conclusions:

• Clinical trial simulation (CTS) should be integrated into future drug development to support decision-making and accelerate the process.
• Overcoming data sharing and privacy concerns is crucial for the widespread adoption of CTS.
• CTS is a key enabler for the realization of P4 medicine, transforming therapeutic research and patient management.