End points and United States Food and Drug Administration approval of oncology drugs.
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Summary
End points other than survival were the approval basis for 68% of oncology drug marketing applications granted regular approval and for all 14 applications granted accelerated approval from January 1, 1990, to November 1, 2002.
- Type
- article
- Published
- 2003-04-01
- Cited by
- 485
- References
- 14
- OpenAlex
- https://openalex.org/W2104389711
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:26069206
Keywords
Medicine, Food and drug administration, Drug approval, Surrogate endpoint, Cancer drugs
References
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- Reporting results of cancer treatment
- Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials.
- The case for a new national program for the development of cancer therapeutics.
- FDA Role in Cancer Drug Development and Requirements for Approval
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- Approval Summary: Nelarabine for the Treatment of T-Cell Lymphoblastic Leukemia/Lymphoma
- Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial.
- Progression-free survival and time to progression as primary end points in advanced breast cancer: often used, sometimes loosely defined.
- Elucidation of Relationship Between Tumor Size and Survival in Non‐Small‐Cell Lung Cancer Patients Can Aid Early Decision Making in Clinical Drug Development
- Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature.
- Outcomes and endpoints in trials of cancer treatment: the past, present, and future.
- Clinical trial design and regulatory issues for therapeutic cancer vaccines.
- [When defense becomes dangerous--transcription factor Nrf2 and cancer].
- Teure Innovationen in der Onkologie – für alle?
- Progressive epithelial ovarian carcinoma. Prognostic factors and clinical management.
- [Radiological evaluation of tumor response in oncological studies (tumor response evaluation)].
- Wirkmechanismus des bispezifischen anti-CD19 x anti-CD3 BiTE-Antikörpers MT103 in Patienten mit rezidivem indolenten B-Zell-Non-Hodgkin-Lymphom
- Cardiovascular drug development: is it dead or just hibernating?
- A Pilot Study of Individualized Maximum Repeatable Dose (iMRD), a New Dose Finding System, of Weekly Gemcitabine for Patients With Metastatic Pancreas Cancer
- Progression-Free Survival: What Does It Mean for Psychological Well-Being or Quality of Life?
- Innovation In The Biopharmaceutical Industry
- Exploring the regulatory decision-making process for medicines
- Medical Freedom Zones
- DICOM Structured Reporting and Cancer Clinical Trials Results
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