edoc

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

Speich, Benjamin and von Niederhäusern, Belinda and Blum, Claudine Angela and Keiser, Jennifer and Schur, Nadine and Fürst, Thomas and Kasenda, Benjamin and Christ-Crain, Mirjam and Hemkens, Lars G. and Pauli-Magnus, Christiane and Schwenkglenks, Matthias and Briel, Matthias and MAking Randomized Trials Affordable Group, . (2018) Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list. Journal of clinical epidemiology, 96. pp. 73-83.

Full text not available from this repository.

Official URL: https://edoc.unibas.ch/62683/

Downloads: Statistics Overview

Abstract

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.; 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.; 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.; 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.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Epidemiology and Public Health (EPH) > Household Economics and Health Systems Research > Household Economics and Health Systems Research (Fink)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology > Helminth Drug Development (Keiser)
UniBasel Contributors:Fürst, Thomas
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Pergamon Press
ISSN:0895-4356
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:09 Apr 2019 15:06
Deposited On:02 Jul 2018 11:56

Repository Staff Only: item control page