The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs

The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs

Abstract Background The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database providing the relevant...

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Bibliographic Details
Main Authors: Aviv Ladanie, Benjamin Speich, Florian Naudet, Arnav Agarwal, Tiago V. Pereira, Francesco Sclafani, Juan Martin-Liberal, Thomas Schmid, Hannah Ewald, John P. A. Ioannidis, Heiner C. Bucher, Benjamin Kasenda, Lars G. Hemkens
Format: Article
Language:English
Published: BMC 2018-09-01
Series:Trials
Subjects:
US Food and Drug Administration (FDA)
Drug regulation
Marketing authorization
Approval package
Drugs and biologics
Clinical trials
Online Access:http://link.springer.com/article/10.1186/s13063-018-2877-z

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http://link.springer.com/article/10.1186/s13063-018-2877-z

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