Using Epidemiological Data to Inform Clinical Trial Feasibility Assessments: A Case Study.

ABSTRACT:

Background

Clinical trial enrollment and completion is challenging, with nearly half of all trials not being completed or not completed on time. In 2014, the National Institutes of Health StrokeNet in collaboration with stroke epidemiologists from GCNKSS (Greater Cincinnati/Northern Kentucky Stroke Study) began providing proposed clinical trials with formal trial feasibility assessments. Herein, we describe the process of prospective feasibility analyses using epidemiological data that can be used to improve enrollment and increase the likelihood a trial is completed.

Methods

In 2014, DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3) trialists, National Institutes of Health StrokeNet, and stroke epidemiologists from GCNKSS collaborated to eva

SUBMITTER: Stanton RJ 

PROVIDER: S-EPMC10050115 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature