Design and rationale for an empirical investigation of the resource use and costs of investigator-initiated randomized trials in Switzerland, the UK, and Germany.
Conduct
Costs
Costs of clinical trials
Finalization
Planning
RCTs
Resource use
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
07 Oct 2024
07 Oct 2024
Historique:
received:
23
01
2024
accepted:
23
09
2024
medline:
8
10
2024
pubmed:
8
10
2024
entrez:
7
10
2024
Statut:
epublish
Résumé
Conducting high-quality randomized clinical trials (RCTs) is challenging, time consuming, and resource intense. Academic investigators usually depend on scarce financial resources; however, current literature lacks systematically collected empirical data on the detailed resource use and costs of investigator-initiated RCTs. The aim of this study is to generate a database of detailed empirical resource use and cost data from 100 investigator-initiated RCTs in Switzerland, Germany, and the UK. Investigators enter their empirical costs data into an online data collection form, which is followed by a short interview and a detailed cost report. We plan to investigate cost patterns and cost drivers and examine planned versus actual RCT costs as well as explore different strata of costs across the planning, conduct, and finalization phases, in drug and non-drug trials, and across medical fields and countries. This study will add detailed empirical data to the limited research on investigator-initiated RCT costs currently available. A study limitation will be that cost data will be retrospective and self-reported, which might be inaccurate depending on how costs were recorded. Open Science Framework (OSF) https://doi.org/10.17605/OSF.IO/QY2GU . Registered on June 4, 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Conducting high-quality randomized clinical trials (RCTs) is challenging, time consuming, and resource intense. Academic investigators usually depend on scarce financial resources; however, current literature lacks systematically collected empirical data on the detailed resource use and costs of investigator-initiated RCTs.
METHODS
METHODS
The aim of this study is to generate a database of detailed empirical resource use and cost data from 100 investigator-initiated RCTs in Switzerland, Germany, and the UK. Investigators enter their empirical costs data into an online data collection form, which is followed by a short interview and a detailed cost report. We plan to investigate cost patterns and cost drivers and examine planned versus actual RCT costs as well as explore different strata of costs across the planning, conduct, and finalization phases, in drug and non-drug trials, and across medical fields and countries.
DISCUSSION
CONCLUSIONS
This study will add detailed empirical data to the limited research on investigator-initiated RCT costs currently available. A study limitation will be that cost data will be retrospective and self-reported, which might be inaccurate depending on how costs were recorded.
TRIAL REGISTRATION
BACKGROUND
Open Science Framework (OSF) https://doi.org/10.17605/OSF.IO/QY2GU . Registered on June 4, 2021.
Identifiants
pubmed: 39375767
doi: 10.1186/s13063-024-08505-y
pii: 10.1186/s13063-024-08505-y
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
662Informations de copyright
© 2024. The Author(s).
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