English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

A working group of the American Statistical Association (ASA) Biopharmaceutical Section has published three comprehensive articles in this journal that survey the practices and identify opportunities for using real-world data (RWD) and evidence in clinical design and analysis to inform regulatory decision making. This article extends the discussion of bias for RWD and explores the possibilities of patient registries and medical records of excellent quality. Leadership by the FDA for real-world evidence (RWE) is highlighted, with examples of label expansion and new product development. Propensity scores and Bayesian methods for RWD are discussed in the context of regulatory environment.

Some Biostatistical Considerations About Real-World Data and Evidence in Clinical Studies, Especially for Regulatory Purposes