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.

Details

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State: Public
Version: Final published version
License: Not specified
Serval ID
serval:BIB_924A734CDB19
Type
Article: article from journal or magazin.
Collection
Publications
Institution
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.
Journal
PloS one
Author(s)
Speich B., Schur N., Gryaznov D., von Niederhäusern B., Hemkens L.G., Schandelmaier S., Amstutz A., Kasenda B., Pauli-Magnus C., Ojeda-Ruiz E., Tomonaga Y., McCord K., Nordmann A., von Elm E., Briel M., Schwenkglenks M.
Working group(s)
a collaboration of the MARTA (MAking Randomized Trials Affordable) and ASPIRE (Adherence to Standard Protocol Items: REcommendations for interventional trials) Study Groups
ISSN
1932-6203 (Electronic)
ISSN-L
1932-6203
Publication state
Published
Issued date
2019
Peer-reviewed
Oui
Volume
14
Number
1
Pages
e0210669
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: epublish
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.
Keywords
Costs and Cost Analysis, Ethics Committees, Research/economics, Ethics Committees, Research/statistics & numerical data, Humans, Randomized Controlled Trials as Topic, Switzerland, Time Factors
Pubmed
Web of science
Open Access
Yes
Create date
17/01/2019 13:01
Last modification date
22/10/2019 6:11
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