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Open Access
Peer-reviewed
Research Article
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
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Benjamin Speich,
Roles Conceptualization, Data curation, Formal analysis, Methodology, Writing – original draft
Affiliation Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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Nadine Schur,
Roles Data curation, Formal analysis, Investigation, Writing – original draft, Writing – review & editing
Affiliation Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland
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Dmitry Gryaznov,
Roles Data curation, Formal analysis, Methodology, Writing – original draft, Writing – review & editing
Affiliation Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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Belinda von Niederhäusern,
Roles Conceptualization, Data curation, Investigation, Writing – review & editing
Affiliation Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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Lars G. Hemkens,
Roles Data curation, Methodology, Writing – review & editing
Affiliation Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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Stefan Schandelmaier,
Roles Data curation, Writing – review & editing
Affiliations Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
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Alain Amstutz,
Roles Data curation, Writing – review & editing
Affiliation Swiss Tropical and Public Health Institute, and Division of Infectious Diseases and Hospital Epidemiology, University of Basel and University Hospital Basel, Basel, Switzerland
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Benjamin Kasenda,
Roles Data curation, Writing – review & editing
Affiliations Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland, Department of Medical Oncology, University of Basel and University Hospital Basel, Basel, Switzerland
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Christiane Pauli-Magnus,
Roles Data curation, Writing – review & editing
Affiliation Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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Elena Ojeda-Ruiz,
Roles Data curation, Writing – review & editing
Affiliation National Centre for Epidemiology, Instituto de Salud Carlos III, Madrid, Spain
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Yuki Tomonaga,
Roles Data curation, Writing – review & editing
Affiliation Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
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Kimberly McCord,
Roles Data curation, Writing – review & editing
Affiliation Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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Alain Nordmann,
Roles Data curation, Writing – review & editing
Affiliation Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland
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Erik von Elm,
Roles Data curation, Methodology, Writing – review & editing
Affiliation Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland
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Matthias Briel ,
Contributed equally to this work with: Matthias Briel, Matthias Schwenkglenks
Roles Conceptualization, Investigation, Methodology, Supervision, Writing – review & editing
* E-mail: matthias.briel@usb.ch
¶‡ These authors are co-last authors on this work.
Affiliations Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
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Matthias Schwenkglenks ,
Contributed equally to this work with: Matthias Briel, Matthias Schwenkglenks
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Methodology, Project administration, Supervision, Writing – review & editing
¶‡ These authors are co-last authors on this work.
Affiliations Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
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a collaboration of the MARTA (MAking Randomized Trials Affordable) and ASPIRE (Adherence to Standard Protocol Items: REcommendations for interventional trials) Study Groups
¶The complete membership lists can be found in the Acknowledgment
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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
- Benjamin Speich,
- Nadine Schur,
- Dmitry Gryaznov,
- Belinda von Niederhäusern,
- Lars G. Hemkens,
- Stefan Schandelmaier,
- Alain Amstutz,
- Benjamin Kasenda,
- Christiane Pauli-Magnus,
- Elena Ojeda-Ruiz
- Published: January 11, 2019
- https://doi.org/10.1371/journal.pone.0210669