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The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making
Mary Summer Starling1,2, Lindsay Kehoe1, Bruce K Burnett3
1The Clinical Trials Transformation Initiative, Duke Clinical Research Institute, Durham, North Carolina, USA.
Clinical Pharmacology and Therapeutics
|October 16, 2024
Summary
Disease progression modeling (DPM) can significantly improve medical product development and clinical trials. This article highlights DPM
Area of Science:
- * Pharmacometrics and clinical pharmacology
- * Regulatory science and drug development
Background:
- * Disease progression modeling (DPM) is recognized for its potential in clinical trials but its full value in medical product development is not yet realized.
- * The Clinical Trials Transformation Initiative (CTTI) formed a diverse team to advance DPM use in decision-making for clinical trials and product development.
Purpose of the Study:
- * To explore current applications of DPM through a scoping review.
- * To discuss the value of DPM in medical product development via a multi-stakeholder expert meeting.
- * To propose key questions for developers and regulators to inform clinical development strategy using DPM.
Main Methods:
- * Conducted a scoping review of existing DPM applications.
- * Convened a multi-stakeholder expert meeting involving patients, academics, regulators, and industry professionals.
- * Synthesized findings from the review and meeting to identify key questions for DPM implementation.
Main Results:
- * Identified current applications and discussed the value of DPM in medical product development.
- * Highlighted the potential of DPM to inform clinical development strategy, therapeutic context, and endpoint selection.
- * Proposed questions to optimize trial design and enhance the quality and efficiency of medical product development.
Conclusions:
- * DPM offers significant potential to improve the quality and efficiency of medical product development.
- * Expanding awareness of DPM's unique value is crucial for its broader adoption.
- * This work aims to guide developers and regulators in leveraging DPM for better clinical trial outcomes.
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