Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation.

<h4>Background</h4>The preparation of a randomized controlled trial (RCT) requires substantial resources and the administrative processes can be burdensome. To facilitate the conduct of RCTs it is important to better understand cost drivers. In January 2014 the enactment of the new Swiss...

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Main Authors: Benjamin Speich, Nadine Schur, Dmitry Gryaznov, Belinda von Niederhäusern, Lars G Hemkens, Stefan Schandelmaier, Alain Amstutz, Benjamin Kasenda, Christiane Pauli-Magnus, Elena Ojeda-Ruiz, Yuki Tomonaga, Kimberly McCord, Alain Nordmann, Erik von Elm, Matthias Briel, Matthias Schwenkglenks, a collaboration of the MARTA (MAking Randomized Trials Affordable) and ASPIRE (Adherence to Standard Protocol Items: REcommendations for interventional trials) Study Groups
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2019-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0210669