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This book provides state-of-art statistical methodologies,
practical considerations from regulators and sponsors, logistics,
and real use cases for practitioners for the uptake of RWE/D.
Randomized clinical trials have been the gold standard for the
evaluation of efficacy and safety of medical products. However, the
cost, duration, practicality, and limited generalizability have
incentivized many to look for alternative ways to optimize drug
development. This book provides a comprehensive list of topics
together to include all aspects with the uptake of RWE/D,
including, but not limited to, applications in regulatory and
non-regulatory settings, causal inference methodologies,
organization and infrastructure considerations, logistic
challenges, and practical use cases.
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