GSKM Alan BrookhartEmory UniversityAmgen Inc.University of North Carolina at Chapel HillAbstract/ManuscriptAarhus UniversityJennifer B. ChristianApproval & CommercializationYesRegeneron PharmaceuticalsNational Cheng Kung UniversityR&DColumbia University
Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence.
Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence
Challenge
Pharmacoepidemiology lacked a consolidated framework articulating the methodological, regulatory, and technological factors driving the evolution of real-world evidence as a credible input to healthcare decision-making.
Solution
Target RWE's scientific leadership co-authored a landmark review in Clinical Pharmacology & Therapeutics synthesizing the four forces driving the RWE era: rich healthcare data, advanced extraction technologies, principled causal inference methods, and global regulatory guidance.