Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

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

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