Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list.
- Speich B Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
- von Niederhäusern B Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
- Blum CA Department of Internal Medicine and Department of Clinical Research, Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland; Departments of General Internal and Emergency Medicine and Department of Endocrinology, Diabetology and Clinical Nutrition, Medical University Clinic, Cantonal Hospital Aarau, Aarau, Switzerland.
- Keiser J Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland.
- Schur N Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland.
- Fürst T Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland; Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland; School of Public Health, Imperial College London, London, United Kingdom.
- Kasenda B 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.
- Christ-Crain M Department of Internal Medicine and Department of Clinical Research, Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.
- Hemkens LG Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
- Pauli-Magnus C Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
- Schwenkglenks M Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland; Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.
- Briel M 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, Ontario, Canada. Electronic address: matthias.briel@usb.ch.
- 2018-01-03
Published in:
- Journal of clinical epidemiology. - 2018
Case report
Clinical trial costs
Cost drivers
Randomized clinical trials
Resource use
Costs and Cost Analysis
Humans
Outcome Assessment, Health Care
Randomized Controlled Trials as Topic
Research Personnel
Retrospective Studies
Time Factors
English
OBJECTIVES
Randomized clinical trials (RCTs) are costly and published information on resource requirements for their conduct is limited. To identify key factors for making RCTs more sustainable, empirical data on resource use and associated costs are needed. We aimed to retrospectively assess resource use and detailed costs of two academic, investigator-initiated RCTs using a comprehensive list of cost items.
STUDY DESIGN AND SETTING
The resource use of two investigator-initiated RCTs (Prednisone-Trial [NCT00973154] and Oxantel-Trial [ISRCTN54577342]) was empirically assessed in a standardized manner through semistructured interviews and a systematically developed cost item list. Using information about yearly salaries, resource use was translated into costs. In addition, we collected all "other costs" including fixed priced items. Overall costs as well as cost of different study phases were calculated.
RESULTS
The personnel time used in the Prednisone-Trial trial was approximately 2,897 working days and the overall costs were calculated to be USD 2.3 million, which was USD 700,000 more than planned. In the Oxantel-Trial 798 working days were spent and the overall costs were as originally planned USD 100,000. Cost drivers were similar between the two RCTs with recruitment delays explaining the additional costs in the Prednisone-Trial.
CONCLUSION
This case study provides an example of how to transparently assess resources and costs of RCTs and presents detailed empirical data on type and magnitude of expenses. In the future, this model approach may serve others to plan, assess, or monitor resource use and costs of RCTs.
Randomized clinical trials (RCTs) are costly and published information on resource requirements for their conduct is limited. To identify key factors for making RCTs more sustainable, empirical data on resource use and associated costs are needed. We aimed to retrospectively assess resource use and detailed costs of two academic, investigator-initiated RCTs using a comprehensive list of cost items.
STUDY DESIGN AND SETTING
The resource use of two investigator-initiated RCTs (Prednisone-Trial [NCT00973154] and Oxantel-Trial [ISRCTN54577342]) was empirically assessed in a standardized manner through semistructured interviews and a systematically developed cost item list. Using information about yearly salaries, resource use was translated into costs. In addition, we collected all "other costs" including fixed priced items. Overall costs as well as cost of different study phases were calculated.
RESULTS
The personnel time used in the Prednisone-Trial trial was approximately 2,897 working days and the overall costs were calculated to be USD 2.3 million, which was USD 700,000 more than planned. In the Oxantel-Trial 798 working days were spent and the overall costs were as originally planned USD 100,000. Cost drivers were similar between the two RCTs with recruitment delays explaining the additional costs in the Prednisone-Trial.
CONCLUSION
This case study provides an example of how to transparently assess resources and costs of RCTs and presents detailed empirical data on type and magnitude of expenses. In the future, this model approach may serve others to plan, assess, or monitor resource use and costs of RCTs.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/j.jclinepi.2017.12.022
- PMID 29292203
- Persistent URL
- https://sonar.ch/global/documents/47435
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