The On- and Off-Ramps of Oncology Accelerated Approval-Reference-Cited by-同舟云学术

The On- and Off-Ramps of Oncology Accelerated Approval

Published:2022-10-20 Issue:16 Volume:387 Page:1439-1442
ISSN:0028-4793
Container-title:New England Journal of Medicine
language:en
Short-container-title:N Engl J Med

Author:

Fashoyin-Aje Lola A.¹^ORCID,Mehta Gautam U.¹^ORCID,Beaver Julia A.¹,Pazdur Richard¹

Affiliation:

1. From the Office of Oncologic Diseases, Center for Drug Evaluation and Research (L.A.F.-A., G.U.M., J.A.B., R.P.), and the Oncology Center of Excellence (L.A.F.-A, J.A.B., R.P.), Food and Drug Administration, Silver Spring, MD.

Publisher

Massachusetts Medical Society

Subject

General Medicine

Link

http://www.nejm.org/doi/pdf/10.1056/NEJMp2208954

Reference4 articles.

1. The use of plasma HIV RNA as a study endpoint in efficacy trials of antiretroviral drugs

2. “Dangling” Accelerated Approvals in Oncology

3. The Drug-Dosing Conundrum in Oncology — When Less Is More

4. Optimal two-stage designs for phase II clinical trials

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