What is it about?

There has been a growing number of oncology drug approvals. Non-interventional post-authorization safety/effectives studies (PASSs/PAESs) aim to provide real-world evidence (RWE) on the safety/effectiveness of oncology drugs post-approval. This article provided a summary of the characteristics such study design and data sources of current non-interventional PASSs/PAESs that aimed to generate RWE for oncology drugs.

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Why is it important?

Findings of this study help us better understand the current landscape of oncology-specific non-interventional PASSs/PAESs and provide insights for the future design of non-interventional PASSs/PAESs studies for oncology drugs.

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This page is a summary of: Regulator‐Requested Non‐Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review, Clinical Pharmacology & Therapeutics, November 2021, Wiley, DOI: 10.1002/cpt.2450.
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