Resource use, costs, and approval times for planning and preparing a randomized clinical trial befor...
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
About this item
Full title
Author / Creator
Speich, Benjamin , Schur, Nadine , Gryaznov, Dmitry , von Niederhäusern, Belinda , Hemkens, Lars G , Schandelmaier, Stefan , Amstutz, Alain , Kasenda, Benjamin , Pauli-Magnus, Christiane , Ojeda-Ruiz, Elena , Tomonaga, Yuki , McCord, Kimberly , Nordmann, Alain , von Elm, Erik , Briel, Matthias , Schwenkglenks, Matthias and a collaboration of the MARTA (MAking Randomized Trials Affordable) and ASPIRE (Adherence to Standard Protocol Items: REcommendations for interventional trials) Study Groups
Publisher
United States: Public Library of Science
Journal title
Language
English
Formats
Publication information
Publisher
United States: Public Library of Science
Subjects
More information
Scope and Contents
Contents
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 Legislation on Human Research (LHR) considerably changed the regulatory framewor...
Alternative Titles
Full title
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
Authors, Artists and Contributors
Author / Creator
Schur, Nadine
Gryaznov, Dmitry
von Niederhäusern, Belinda
Hemkens, Lars G
Schandelmaier, Stefan
Amstutz, Alain
Kasenda, Benjamin
Pauli-Magnus, Christiane
Ojeda-Ruiz, Elena
Tomonaga, Yuki
McCord, Kimberly
Nordmann, Alain
von Elm, Erik
Briel, Matthias
Schwenkglenks, Matthias
a collaboration of the MARTA (MAking Randomized Trials Affordable) and ASPIRE (Adherence to Standard Protocol Items: REcommendations for interventional trials) Study Groups
Identifiers
Primary Identifiers
Record Identifier
TN_cdi_plos_journals_2166349948
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_plos_journals_2166349948
Other Identifiers
ISSN
1932-6203
E-ISSN
1932-6203
DOI
10.1371/journal.pone.0210669
