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

Budget planning Clinical trial cost Randomized clinical trials Resource use Scoping review Template

Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
01 2020
Historique:
received: 20 05 2019
revised: 16 08 2019
accepted: 12 09 2019
pubmed: 19 9 2019
medline: 7 8 2020
entrez: 19 9 2019
Statut: ppublish

Résumé

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

Identifiants

pubmed: 31533072
pii: S0895-4356(19)30439-1
doi: 10.1016/j.jclinepi.2019.09.009
pii:
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

9-19

Informations de copyright

Copyright © 2019 Elsevier Inc. All rights reserved.

Auteurs

Benjamin Speich (B)

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: benjamin.speich@ndorms.ox.ac.uk.

Viktoria Gloy (V)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland.

Nadine Schur (N)

Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland.

Hannah Ewald (H)

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.

Lars G Hemkens (LG)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland.

Matthias Schwenkglenks (M)

Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland; Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.

Matthias Briel (M)

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.

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