Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list

Benjamin Speich; Belinda von Niederhäusern; Claudine Angela Blum; Jennifer Keiser; Nadine Schur; Thomas Fürst; Benjamin Kasenda; Mirjam Christ-Crain; Lars G Hemkens; Christiane Pauli-Magnus; Matthias Schwenkglenks; Matthias Briel; MAking Randomized Trials Affordable (MARTA) Group

doi:10.1016/j.jclinepi.2017.12.022

Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list

J Clin Epidemiol. 2018 Apr:96:73-83. doi: 10.1016/j.jclinepi.2017.12.022. Epub 2017 Dec 30.

Collaborators

MAking Randomized Trials Affordable (MARTA) Group:
Benjamin Speich¹⁰, Belinda von Niederhäusern², Nadine Schur¹¹, Lars G Hemkens¹⁰, Benjamin Kasenda¹², Christiane Pauli-Magnus², Matthias Schwenkglenks⁸, Matthias Briel¹³

Affiliations

¹ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
² Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
³ 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.
⁴ Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland.
⁵ 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.
⁶ 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.
⁷ Department of Internal Medicine and Department of Clinical Research, Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.
⁸ Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland; Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.
⁹ 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.
¹⁰ Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland.
¹¹ Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland.
¹² Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland; Department of Medical Oncology, University of Basel and University Hospital Basel, Basel, Switzerland.
¹³ Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

PMID: 29292203
DOI: 10.1016/j.jclinepi.2017.12.022

Abstract

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.

Keywords: Case report; Clinical trial costs; Cost drivers; Randomized clinical trials; Resource use.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Costs and Cost Analysis / methods*
Humans
Outcome Assessment, Health Care
Randomized Controlled Trials as Topic / economics*
Research Personnel / economics*
Retrospective Studies
Time Factors