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
<strong>Background</strong> 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...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
Public Library of Science
2019
|
| _version_ | 1797067698907119616 |
|---|---|
| author | Speich, B Schur, N Gryaznov, D Von Niederhäusern, B Hemkens, L 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 MARTA Study Group, ASPIRE Study Group, |
| author_facet | Speich, B Schur, N Gryaznov, D Von Niederhäusern, B Hemkens, L 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 MARTA Study Group, ASPIRE Study Group, |
| author_sort | Speich, B |
| collection | OXFORD |
| description | <strong>Background</strong> 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. <br/><br/> <strong>Methods</strong>> 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. <br/><br/> <strong>Results</strong> 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. <br/><br/> <strong>Conclusion</strong> 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. |
| first_indexed | 2024-03-06T22:00:01Z |
| format | Journal article |
| id | oxford-uuid:4e43b06e-0cc3-4ff1-b472-988ed0655277 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:00:01Z |
| publishDate | 2019 |
| publisher | Public Library of Science |
| record_format | dspace |
| spelling | oxford-uuid:4e43b06e-0cc3-4ff1-b472-988ed06552772022-03-26T16:00:17ZResource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislationJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:4e43b06e-0cc3-4ff1-b472-988ed0655277EnglishSymplectic Elements at OxfordPublic Library of Science2019Speich, BSchur, NGryaznov, DVon Niederhäusern, BHemkens, LSchandelmaier, SAmstutz, AKasenda, BPauli-Magnus, COjeda-Ruiz, ETomonaga, YMcCord, KNordmann, AVon Elm, EBriel, MSchwenkglenks, MMARTA Study Group,ASPIRE Study Group,<strong>Background</strong> 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. <br/><br/> <strong>Methods</strong>> 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. <br/><br/> <strong>Results</strong> 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. <br/><br/> <strong>Conclusion</strong> 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. |
| spellingShingle | Speich, B Schur, N Gryaznov, D Von Niederhäusern, B Hemkens, L 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 MARTA Study Group, ASPIRE Study Group, 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 |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| work_keys_str_mv | AT speichb resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT schurn resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT gryaznovd resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT vonniederhausernb resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT hemkensl resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT schandelmaiers resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT amstutza resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT kasendab resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT paulimagnusc resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT ojedaruize resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT tomonagay resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT mccordk resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT nordmanna resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT vonelme resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT brielm resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT schwenkglenksm resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT martastudygroup resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation AT aspirestudygroup resourceusecostsandapprovaltimesforplanningandpreparingarandomizedclinicaltrialbeforeandaftertheimplementationofthenewswisshumanresearchlegislation |