Efficacy gap between phase II and subsequent phase III studies in oncology-Reference-Cited by-同舟云学术

Efficacy gap between phase II and subsequent phase III studies in oncology

Published:2020-02-21 Issue:7 Volume:86 Page:1306-1313
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Vreman Rick A.¹²^ORCID,Belitser Svetlana V.¹,Mota Ana T.M.¹,Hövels Anke M.¹,Goettsch Wim G.¹²,Roes Kit C.B.³,Leufkens Hubert G.M.¹,Mantel‐Teeuwisse Aukje K.¹

Affiliation:

1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS)Utrecht University The Netherlands

2. The National Health Care Institute (ZIN) Diemen The Netherlands

3. Department of Health Evidence, BiostatisticsRadboud University Medical Center, Radboud University Nijmegen The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14237

Reference33 articles.

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2. European Medicines Agency.CPMP. E8 (CPMP/ICH/291/95) General Considerations for Clinical Trials. London. 1997. [Internet]. [cited2018Sep 7]. Available from:http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001255.jsp&mid=WC0b01ac0580032ec4

3. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

4. European Marketing Authorizations Granted Based on a Single Pivotal Clinical Trial: The Rule or the Exception?

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