Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019

Author:

Tenhunen Olli12,Lasch Florian3,Schiel Anja4,Turpeinen Miia1ORCID

Affiliation:

1. Medical Research Center Oulu Oulu University Hospital University of Oulu Oulu Finland

2. Finnish Medicines Agency Helsinki Finland

3. Hannover Medical School Hannover Germany

4. Norwegian Medicines Agency Oslo Norway

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference20 articles.

1. Seamless designs: current practice and considerations for early‐phase drug development in oncology;Hobbs B.P.;J. Natl. Cancer Inst.,2019

2. Seamless Oncology-Drug Development

3. European Medicines Agency (EMA).Guideline on the evaluation of anticancer medicinal products in man.. Accessed February 18 2020.

4. Personalized medicine in oncology: the future is now

5. Basket Trials and the Evolution of Clinical Trial Design in an Era of Genomic Medicine

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