Design and rationale for an empirical investigation of the resource use and costs of investigator-initiated randomized trials in Switzerland, the UK, and Germany.

ABSTRACT:

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

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 d

SUBMITTER: Griessbach A 

PROVIDER: S-EPMC11457363 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature