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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

Speich, Benjamin and Schur, Nadine and Gryaznov, Dmitry and von Niederhäusern, Belinda and Hemkens, Lars G. and Schandelmaier, Stefan and Amstutz, Alain and Kasenda, Benjamin and Pauli-Magnus, Christiane and Ojeda-Ruiz, Elena and Tomonaga, Yuki and McCord, Kimberly and Nordmann, Alain and von Elm, Erik and Briel, Matthias and Schwenkglenks, Matthias and a collaboration of the Marta Aspire Study Groups, . (2019) 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. PLoS ONE, 14 (1). e0210669.

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Abstract

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 framework in Switzerland. We assess if the new LHR was associated with change in (i) resource use and costs to prepare an RCT, and (ii) approval times with research ethics committees (RECs) and the regulatory authority Swissmedic.; We surveyed investigators of RCTs which were approved by RECs in 2012 or in 2016 and asked for RCT preparation costs using a pre-specified item list. Additionally, we collected approval times from RECs and Swissmedic.; The response rates of the investigator survey were 8.3% (19/228) for 2012 and 16.5% (47/285) in 2016. The median preparation cost of an RCT was USD 72,400 (interquartile range [IQR]: USD 59,500-87,700; n = 18) in 2012 and USD 72,600 (IQR: USD 42,800-169,600; n = 35) in 2016. For single centre RCTs a median REC approval time of 82 (IQR: 49-107; n = 38) days in 2012 and 92 (IQR: 65-131; n = 63) days in 2016 was observed. The median Swissmedic approval time for any clinical trial was 27 (IQR: 19-51; n = 213) days in 2012 and 49 (IQR: 36-67; n = 179) days in 2016. The total duration for achieving RCT approval from both authorities (REC and Swissmedic) in the parallel submission procedure applied in 2016 could not be assessed.; Based on limited data the costs to plan and prepare RCTs in Switzerland were approximately USD 72,000 in 2012 and 2016. For effective and valid research on costs and approval times of RCTs a greater willingness to share cost information among investigators and more collaboration between stakeholders with data linkage is necessary.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Former Units within Swiss TPH > Clinical Operations (Urich)
03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H)
03 Faculty of Medicine > Departement Klinische Forschung > Clinical Trial Unit > Clinical Trial Unit (Pauli-Magnus)
03 Faculty of Medicine > Departement Public Health > Pharmazeutische Medizin ECPM > Pharmazeutische Medizin (Szucs)
UniBasel Contributors:Schwenkglenks, Matthias and Gryaznov, Dmitry and Schur, Nadine and von Niederhäusern, Belinda and Hemkens, Lars G. and Schandelmaier, Stefan and Amstutz, Alain and Kasenda, Benjamin and Pauli-Magnus, Christiane and Nordmann, Alain J. and Briel, Matthias
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Public Library of Science
e-ISSN:1932-6203
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
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edoc DOI:
Last Modified:02 Jun 2020 09:32
Deposited On:29 Jan 2019 15:48

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