Real World Evidence in Drug Development and Evaluation 1st Edition Harry Yang, Binbing Yu – Ebook PDF Instant Download/Delivery ISBN(s): 9780429676819, 0429676816
Product details:
- ISBN 10: 0429676816
- ISBN 13: 9780429676819
- Author: Harry Yang, Binbing Yu
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Table contents:
1. Using Real-World Evidence to Transform Drug Development: Opportunities and Challenges
2. Evidence Derived from Real-World Data: Utility, Constraints, and Cautions
3. Real-World Evidence from Population-Based Cancer Registry Data
4. External Control Using RWE and Historical Data in Clinical Development
5. Bayesian Methods for Evaluating Drug Safety with Real-World Evidence
6. Real-World Evidence for Coverage and Payment Decisions
7. Causal Inference for Observational Studies/Real-World Data
8. Introduction to Artificial Intelligence and Deep Learning with a Case Study in Analyzing Electronic Health Records for Drug Development
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