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USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products

Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics".

The Accelerated Pathway is a program initiated by the US Food and Drug Administration (FDA) to speed up the approval process for drugs that treat serious or life-threatening illnesses.

The program is intended to help get important medications to patients faster, while still maintaining high standards for safety and efficacy.

Oncology drugs often undergo accelerated approval in part because of the serious and life-threatening nature of cancer and because of the availability of surrogate or intermediate clinical endpoints.

This guidance is intended to address considerations for designing trials to support accelerated approval of anti-cancer drugs or biological products. Also by using this guide, the sponsors will learn how to design, conduct, and analyze trials for oncology therapeutic products that will support accelerated approvals.

The most robust way to assess efficacy and safety is through randomized controlled trials, which allow direct comparisons with available therapies. A single-arm trial has commonly been used to support accelerated approval, however, randomized controlled trials have the advantage of providing a more robust assessment.

Click this LINK to know more about the recommendations to support Accelerated Approval of Oncology Therapeutic products.


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