A scoping review shows that several nonvalidated budget planning tools for randomized trials are available

Benjamin Speich; Viktoria Gloy; Nadine Schur; Hannah Ewald; Lars G Hemkens; Matthias Schwenkglenks; Matthias Briel; MAking Randomized Trials Affordable (MARTA) Group

doi:10.1016/j.jclinepi.2019.09.009

A scoping review shows that several nonvalidated budget planning tools for randomized trials are available

J Clin Epidemiol. 2020 Jan:117:9-19. doi: 10.1016/j.jclinepi.2019.09.009. Epub 2019 Sep 15.

Authors

Benjamin Speich¹, Viktoria Gloy², Nadine Schur³, Hannah Ewald⁴, Lars G Hemkens², Matthias Schwenkglenks⁵, Matthias Briel⁶; MAking Randomized Trials Affordable (MARTA) Group

Affiliations

¹ Nuffield Department of Orthopaedics, Centre for Statistics in Medicine, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland. Electronic address: [email protected].
² Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland.
³ Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland.
⁴ Nuffield Department of Orthopaedics, Centre for Statistics in Medicine, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; University Medical Library, University of Basel, Basel, Switzerland.
⁵ Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland; Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.
⁶ 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: 31533072
DOI: 10.1016/j.jclinepi.2019.09.009

Abstract

Objectives: We aimed to provide a systematic overview of freely available tools which may help plan or monitor costs for randomized clinical trials (RCTs).

Study design and setting: We systematically searched MEDLINE, EMBASE, and EconLit and conducted internet searches via Google (last search, October 2018). We included all freely available tools and determined their specific purpose, which parts of clinical trial projects and which types of costs they covered, and if they were user-tested or validated in any form.

Results: We identified 25 available tools. Most tools were downloadable on websites from institutions related to clinical research. Seven tools were developed to plan the budget for an entire RCT, 17 tools for calculating budgets of an individual trial center, and one tool for monitoring costs of ongoing RCTs. Eighteen tools considered fixed, variable, and indirect costs. Only two tools were clearly user-tested or validated.

Conclusion: Several freely available tools aim to support investigators in planning costs of an entire trial or in planning the budget for a clinical trial site. How valid and useful they are remains to be shown for most of them. Future tools should be openly shared, user-tested, and validated.

Keywords: Budget planning; Clinical trial cost; Randomized clinical trials; Resource use; Scoping review; Template.

Publication types

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

MeSH terms

Costs and Cost Analysis / methods*
Humans
Internet
Randomized Controlled Trials as Topic / economics*
Research Personnel