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The role of nonrandomized trials in the evaluation of oncology drugs

  • Published:2015-04-07 Issue:5 Volume:97 Page:502-507
  • ISSN:0009-9236
  • Container-title:Clinical Pharmacology & Therapeutics
  • language:en
  • Short-container-title:Clin. Pharmacol. Ther.

Author:

Simon R1,Blumenthal GM2,Rothenberg ML3,Sommer J4,Roberts SA5,Armstrong DK6,LaVange LM2,Pazdur R3

Affiliation:

1. National Cancer Institute; Bethesda Maryland USA

2. Food and Drug Administration (FDA); Silver Spring Maryland USA

3. Pfizer, Inc.; New York New York USA

4. Chordoma Foundation; Durham North Carolina USA

5. Friends of Cancer Research; Washington DC USA

6. Johns-Hopkins Kimmel Cancer Center; Baltimore Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference21 articles.

1. End points and United States Food and Drug Administration approval of oncology drugs;Johnson;J. Clin. Oncol.,2003

2. Cancer: the road to Amiens;Stewart;J. Clin. Oncol.,2009

3. Role of randomized phase III trials in an era of effective targeted therapies;Sharma;Nat. Rev. Clin. Oncol.,2012

4. Development paths for new drugs with large treatment effects seen early;Fleming;Conference on Clinical Cancer Research,2011

5. Assessing the measure of a new drug: is survival the only thing that matters?;Sargent;J. Clin. Oncol.,2008

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