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Activity Number: 526 - Contributed Poster Presentations: Statistics Without Borders
Type: Contributed
Date/Time: Wednesday, August 2, 2017 : 10:30 AM to 12:20 PM
Sponsor: Statistics Without Borders
Abstract #323960
Title: Clinical Trials Start up Process
Author(s): Yi Zhong* and Dinesh Mudaranthakam and Byron Gajewski and Kevin Smilor and Karen Blackwell
Companies: and Department of Biostatistics, University of Kansas Medical Center and Department of Biostatistics, University of Kansas Medical Center and 2. Division of Clinical Research Administration, University of Kansas Medical Center and Human Research Protection Program, University of Kansas Medical Center
Keywords: Clinical Trial Start-Up Process ; non-cancer clinical trial
Abstract:

Exploring strategies to improve efficiencies in clinical trial could accelerate the study processes. One of the more inefficient steps in the clinical trial process has been the study start-up (SSU). Our main intention of this paper was to carefully study each step under the SSU process. The SSU process of clinical trials can be lengthy, and there are multiple, complicated steps to complete. This project was conducted to estimate the activation time or development time for the entire SSU process for non-cancer research studies. Moreover, three important constituents of the entire start-up process were also considered: initial receipt step; IRB review step; and study activation step. Study type of chart review and investigator initiated trials (IIT) had the much shorter activation time than other types of studies(Median=57.5 days and 59 days for chart review and IIT type of studies, respectively). Additionally, single center studies had a much shorter activation time (median=67 days) than multi-center studies. According to our findings, the activation time for study start-up processes can be reasonably estimated based on the study type and scope.


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