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Version 1
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Factors Influencing Timely Initiation of Clinical Trials: An Analysis of Start-up Phase Delays
Version 1
: Received: 21 January 2024 / Approved: 22 January 2024 / Online: 22 January 2024 (07:52:43 CET)
A peer-reviewed article of this Preprint also exists.
Das, S. (n.d.). Factors Influencing Timely Initiation of Clinical Trials: An Analysis of Start-up Phase Delays. https://doi.org/10.35248/2155-9627.24.S18.002 Das, S. (n.d.). Factors Influencing Timely Initiation of Clinical Trials: An Analysis of Start-up Phase Delays. https://doi.org/10.35248/2155-9627.24.S18.002
Abstract
Efficient commencement of clinical trials is pivotal for their successful execution. The purpose of this study was to determine and examine the factors that contribute to trial start-up delays. The study assessed 20 clinical trials' start-up stages in order to identify relevant variables. Results showed that trials with an emphasis on devices, trials that did not outsource, trials that utilized less auxiliary services, and trials that employed interventional designs had quicker start-up times than observational studies. Furthermore, approval times were substantially shortened by using a centralized Institutional Review Board (IRB) rather than a local IRB. Furthermore, compared to studies that successfully enrolled subjects, those who failed to do so required more time to complete contracts and budgets and secure IRB clearance. This study underscores the diverse impact of clinical trial features on start-up timelines. Understanding these factors is crucial for optimizing the initiation process of clinical trials.
Keywords
clinical trials management; process optimization • start-up metrics; start-up phase; trial efficiency
Subject
Medicine and Pharmacology, Other
Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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