The value proposition in clinical trials: a framework for drug development
Year: 2025
Type: article
Abstract: • The concept of value in product development is defined and a brief history presented. • Use of the target product profile in different aspects of drug development is described. • Tools for the incorporation of value into the clinical development process are suggested. Value can be introduced into the clinical drug development process by increasing the probability of success, and through product differentiation. Quality-by-design tools, expected in formulation optimization, are not common in trial design and program optimization. In this paper, I spotlight recent efforts to incorporate these methods and make suggestions for value-driven clinical development. Value-driven product development is introduced by noting the earlier history outside the pharmaceutical sector. A description of innovations in trial design and program structure highlights the recent focus on inserting value into the drug development process. Shrewdly designed trials can provide higher-quality data with fewer subjects and resources, a timelier basis, and more value for companies. There is a value in planning: plan for value.
Source: Drug Discovery Today
Author: Christopher D. Breder
Institution: Johns Hopkins University
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: hybrid
Estimated APC paid: $4,720
OpenAlex ID: W4416273792