Publication Date

3-2024

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Abstract

In 2020, the COVID-19 pandemic drastically altered the way clinical research is conducted through a widespread adoption of telemedicine practices. Using telehealth/telemedicine services allowed researchers to conduct “decentralized clinical trials”, or DCTs, for all or portions of study protocol procedures while maintaining safety measures implemented for pandemic control. However, current review of available literature details the explosion in use of decentralized clinical trials, resulting in gaps in evidence-based outcomes and lack of standardization across research entities. While sponsors and contract research organizations (CROs) tend to lead the charge around adoption of DCTs, research sites are hesitant to make the transition for a plethora of reasons. This research aims to identify and compare barriers for pediatric research sites conducting DCTs or hybrid trials to other research sites, and provide recommendations for a smoother transition to advancements in digital health technology while maintaining pediatric research integrity. An electronic survey was distributed to clinical research professionals at research sites using social media networks and snowball sampling methods. Participants were offered compensation for their responses. Survey questions are derived from private and public clinical research stakeholder reports around various topics including workforce retention and satisfaction scales, site perspective surveys, digital technology needs, and sponsor/CRO communications.

Disciplines

Pediatrics

Notes

Presented at the American Medical Informatics Association (AMIA) 2024 Informatics Summit; Boston, MA; March 18-21, 2024.

Pediatric site response to rapid implementation of decentralized clinical trials

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Pediatrics Commons

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