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
| Autor: | Yuki Tomonaga, Matthias Schwenkglenks, Nadine Schur, Dmitry Gryaznov, Belinda von Niederhäusern, Benjamin Kasenda, Matthias Briel, Kimberly A McCord, Christiane Pauli-Magnus, Benjamin Speich, Alain Amstutz, Erik von Elm, Aspire Study Groups, Elena Ojeda-Ruiz, Lars G. Hemkens, Stefan Schandelmaier, Alain J Nordmann |
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| Přispěvatelé: | SwissFederal Officeof Public Health, a collaboration of the MARTA (MAking Randomized Trials Affordable) and ASPIRE (Adherence to Standard Protocol Items: REcommendations for interventional trials) Study Groups, University of Zurich, Briel, Matthias |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Research Validity
Time Factors Economics Social Sciences law.invention Costs and Cost Analysis Ethics Committees Research/economics Ethics Committees Research/statistics & numerical data Humans Randomized Controlled Trials as Topic Switzerland Geographical Locations 0302 clinical medicine Randomized controlled trial Interquartile range law Medicine and Health Sciences Salaries 030212 general & internal medicine media_common Multidisciplinary Research Assessment Europe Cost driver Resource use Medicine Research Article medicine.medical_specialty Drug Research and Development Science Legislation 610 Medicine & health 1100 General Agricultural and Biological Sciences Research and Analysis Methods 03 medical and health sciences 1300 General Biochemistry Genetics and Molecular Biology medicine media_common.cataloged_instance Clinical Trials European Union European union Pharmacology Research ethics 1000 Multidisciplinary business.industry 10060 Epidemiology Biostatistics and Prevention Institute (EBPI) Randomized Controlled Trials Clinical trial Family medicine Labor Economics People and Places Law and Legal Sciences Clinical Medicine business 030217 neurology & neurosurgery Ethics Committees Research |
| Zdroj: | PloS one, vol. 14, no. 1, pp. e0210669 Repisalud Instituto de Salud Carlos III (ISCIII) PLoS ONE PLoS ONE, Vol 14, Iss 1, p e0210669 (2019) |
| Popis: | BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. This project was funded by the Swiss Federal Office of Public Health. The Swiss Federal Office of Public Health was involved in the protocol development for this study; however was not involved in the data collection and analysis, decision to publish, or preparation of the manuscript. Benjamin Speich was supported by the Research Foundation of the University of Basel. Sí |
| Databáze: | OpenAIRE |
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