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

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...

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Veröffentlicht in:	PloS one 2019-01, Vol.14 (1), p.e0210669-e0210669
Hauptverfasser:	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
Format:	Artikel
Sprache:	eng
Schlagworte:	Administrative expenses Clinical trials Costs Costs and Cost Analysis Decision making Economic aspects Epidemiology Ethics Committees, Research - economics Ethics Committees, Research - statistics & numerical data Health care costs Health care expenditures Health care industry Hospitals Humans Legislation Liability insurance Medical research Medicine and Health Sciences Methods People and Places Pharmaceutical industry Planning Prevention Preventive medicine Randomized Controlled Trials as Topic Regulatory approval Research and Analysis Methods Research ethics Research methodology Researchers Social Sciences Surveys Switzerland Systematic review Time Factors
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