Resource use and costs of investigator-sponsored randomised clinical trials in Switzerland, Germany and the United Kingdom: a meta-research study.

Costs budget clinical trials funding randomised controlled trials resource-use

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:
20 Sep 2024
Historique:
received: 25 06 2024
revised: 12 09 2024
accepted: 16 09 2024
medline: 23 9 2024
pubmed: 23 9 2024
entrez: 22 9 2024
Statut: aheadofprint

Résumé

Conducting high-quality randomised clinical trials (RCTs) is challenging and resource intensive. Funders and academic investigators depend on limited financial resources and, therefore, need empirical data for optimal budget planning. However, current literature lacks detailed empirical data on resource use and costs of investigator-sponsored RCTs. The aim of this study is to systematically collect cost data from investigator-sponsored RCTs from Switzerland, Germany, and the United Kingdom (UK). Principal investigators were asked to share their RCT cost and resource use data and enter it into an online case report form. We assessed cost patterns, cost drivers, and specific cost items, examined costs by study phase (planning-, conduct-, and finalisation phase), compared planned with actual RCT costs, and explored differences in cost patterns across countries, medical fields, and intervention types. We included 93 RCTs which were initiated in Switzerland (n=53; including 8 conducted in low- and lower middle-income countries), Germany (n=22), and the UK (n=18). The median total trial cost in our RCT sample was $645,824 [Interquartile range (IQR), $269,846 to $1,577,924]. The median proportion of the total costs spent for planning phase was 27.5% [IQR, 20.6 to 39.7%], for conduct phase 57.3% [IQR, 44.4%-66.3%], and for finalisation phase 12.7% [IQR, 8.5% to 19.3%] with little variation across countries. The items that contributed most to the total costs were protocol writing (7.2%; IQR 3.8% to 10.6%), data management (5.0%; IQR 2.2% to 8.1%) and follow up (4.5%; IQR 2.3% to 8.4%). Of the 66 RCTs with an available original budget, 46 (69.7%) exceeded the budget by over 50%. Use of routinely collected data to assess primary outcomes was independently associated with lower per patient- and lower total trial costs. Over a quarter of total trial costs were incurred in the planning phase, which is typically not fully funded. Two thirds of RCTs exceeded their budget by more than 50%. Investigators and funders should consider empirical cost data to improve budgeting and funding practices.

Sections du résumé

BACKGROUND BACKGROUND
Conducting high-quality randomised clinical trials (RCTs) is challenging and resource intensive. Funders and academic investigators depend on limited financial resources and, therefore, need empirical data for optimal budget planning. However, current literature lacks detailed empirical data on resource use and costs of investigator-sponsored RCTs. The aim of this study is to systematically collect cost data from investigator-sponsored RCTs from Switzerland, Germany, and the United Kingdom (UK).
METHODS METHODS
Principal investigators were asked to share their RCT cost and resource use data and enter it into an online case report form. We assessed cost patterns, cost drivers, and specific cost items, examined costs by study phase (planning-, conduct-, and finalisation phase), compared planned with actual RCT costs, and explored differences in cost patterns across countries, medical fields, and intervention types.
RESULTS RESULTS
We included 93 RCTs which were initiated in Switzerland (n=53; including 8 conducted in low- and lower middle-income countries), Germany (n=22), and the UK (n=18). The median total trial cost in our RCT sample was $645,824 [Interquartile range (IQR), $269,846 to $1,577,924]. The median proportion of the total costs spent for planning phase was 27.5% [IQR, 20.6 to 39.7%], for conduct phase 57.3% [IQR, 44.4%-66.3%], and for finalisation phase 12.7% [IQR, 8.5% to 19.3%] with little variation across countries. The items that contributed most to the total costs were protocol writing (7.2%; IQR 3.8% to 10.6%), data management (5.0%; IQR 2.2% to 8.1%) and follow up (4.5%; IQR 2.3% to 8.4%). Of the 66 RCTs with an available original budget, 46 (69.7%) exceeded the budget by over 50%. Use of routinely collected data to assess primary outcomes was independently associated with lower per patient- and lower total trial costs.
CONCLUSIONS CONCLUSIONS
Over a quarter of total trial costs were incurred in the planning phase, which is typically not fully funded. Two thirds of RCTs exceeded their budget by more than 50%. Investigators and funders should consider empirical cost data to improve budgeting and funding practices.

Identifiants

DOI: 10.1016/j.jclinepi.2024.111536 PMID: 39307405
pubmed: 39307405
pii: S0895-4356(24)00292-0
doi: 10.1016/j.jclinepi.2024.111536
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

111536

Investigateurs

Benjamin Speich (B)
Belinda von Niederhäusern (B)
Lars G Hemkens (LG)
Alain Amstutz (A)
Benjamin Kasenda (B)
Christiane Pauli-Magnus (C)
Matthias Schwenkglenks (M)
Matthias Briel (M)
Alexandra Griessbach (A)
Stuart McLennan (S)
Stefan Schandelmaier (S)
Ala Taji Heravi (A)
Shaun Treweek (S)

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Auteurs

Alexandra Griessbach (A)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland. Electronic address: alexandranatacha.griessbach@usb.ch.

Benjamin Speich (B)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.

Alain Amstutz (A)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland; Oslo Center for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway; Bristol Medical School, University of Bristol, Bristol, UK.

Lena Hausheer (L)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.

Manuela Covino (M)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.

Hillary Wnfried Ramirez (H)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland; Swiss Tropical Health Institute (Swiss TPH), Basel, Switzerland.

Stefan Schandelmaier (S)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland; MTA-PTE Lendület "Momentum" Evidence in Medicine Research Group, Medical School, University of Pécs, Pécs, Hungary; School of Public Health, University College Cork, Cork, Ireland.

Ala Taji Heravi (A)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.

Shaun Treweek (S)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK; Swiss Tropical Health Institute (Swiss TPH), Basel, Switzerland.

Matthias Schwenkglenks (M)

Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland; Health Economics Facility, Department of Public Health, University of Basel, Basel, Switzerland.

Matthias Briel (M)

CLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Classifications MeSH