Hurdles for the Delivery of Multinational Randomized Clinical Trials.

ABSTRACT: Ethical, administrative, regulatory, and logistical (EARL) procedures can hamper clinical trial delivery. Quantification of these hurdles is rare, prohibiting identification of areas for improvement. To identify and quantify EARL hurdles in trial delivery before and during the COVID-19 pandemic. This cohort study used data from the ongoing Randomized Embedded Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia to enable comparison of EARL procedures for multiple protocols across 19 European countries in the pre-COVID-19 pandemic (February 19, 2016 to March 10, 2020) and COVID-19 pandemic (March 11, 2020, to May 4, 2023) periods. Data were analyzed from November 2024 to March 2025 with contracts and protocol submissions as the units of analysis. Time to (1) site contract

SUBMITTER: van Hout D 

PROVIDER: S-EPMC12223866 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature