Real-World Evidence in Drug Development and Evaluation

This book concerns use of real world data (RWD) and real world evidence (RWE) to aid drug development across product cycle. RWD are healthcare data that are collected outside the constraints of conventual controlled randomized trials (CRTs); whereas RWE is the knowledge derived from aggregation and analysis of RWD.

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