Clinical Pharmacology Applications of Real-World Data and Real-World Evidence in Drug Development and Approval-An Industry Perspective.

Autor: Zhu R; Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA., Vora B; Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA., Menon S; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA., Younis I; Clinical Pharmacology, Gilead Sciences, Inc., Foster City, California, USA., Dwivedi G; Quantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA., Meng Z; R&D Data and Data Science, Clinical Modeling & Evidence Integration, Sanofi, Cambridge, Massachusetts, USA., Datta-Mannan A; Exploratory Medicine & Pharmacology, Eli Lilly and Company, Indianapolis, Indiana, USA., Manchandani P; Clinical Pharmacology and Exploratory Division, Astellas Pharma Global Development, Northbrook, Illinois, USA., Nayak S; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA., Tammara BK; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA., Garhyan P; Global PK/PD/Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA., Iqbal S; Biomarker Sciences, Gilead Sciences, Inc., Foster City, California, USA., Dagenais S; Real World Evidence Center of Excellence, Pfizer, Inc., New York, New York, USA., Chanu P; Clinical Pharmacology, Genentech/Roche, Inc., Lyon, France., Mukherjee A; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA., Ghobadi C; Exploratory Medicine & Pharmacology, Eli Lilly and Company, Indianapolis, Indiana, USA.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2023 Oct; Vol. 114 (4), pp. 751-767. Date of Electronic Publication: 2023 Jul 29.
DOI: 10.1002/cpt.2988
Abstrakt: Since the 21st Century Cures Act was signed into law in 2016, real-world data (RWD) and real-world evidence (RWE) have attracted great interest from the healthcare ecosystem globally. The potential and capability of RWD/RWE to inform regulatory decisions and clinical drug development have been extensively reviewed and discussed in the literature. However, a comprehensive review of current applications of RWD/RWE in clinical pharmacology, particularly from an industry perspective, is needed to inspire new insights and identify potential future opportunities for clinical pharmacologists to utilize RWD/RWE to address key drug development questions. In this paper, we review the RWD/RWE applications relevant to clinical pharmacology based on recent publications from member companies in the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) RWD Working Group, and discuss the future direction of RWE utilization from a clinical pharmacology perspective. A comprehensive review of RWD/RWE use cases is provided and discussed in the following categories of application: drug-drug interaction assessments, dose recommendation for patients with organ impairment, pediatric plan development and study design, model-informed drug development (e.g., disease progression modeling), prognostic and predictive biomarkers/factors identification, regulatory decisions support (e.g., label expansion), and synthetic/external control generation for rare diseases. Additionally, we describe and discuss common sources of RWD to help guide appropriate data selection to address questions pertaining to clinical pharmacology in drug development and regulatory decision making.
(© 2023 IQ Consortium. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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