An integrated approach to improve clinical trial efficiency: Linking a clinical trial management system into the Research Integrated Network of Systems

Autor: Royce Sampson, Steve Shapiro, Wenjun He, Signe Denmark, Katie Kirchoff, Kyle Hutson, Rechelle Paranal, Leila Forney, Kimberly McGhee, Jillian Harvey
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Journal of Clinical and Translational Science, Vol 6 (2022)
Druh dokumentu: article
ISSN: 2059-8661
DOI: 10.1017/cts.2022.382
Popis: Low-accruing clinical trials delay translation of research breakthroughs into the clinic, expose participants to risk without providing meaningful clinical insight, increase the cost of therapies, and waste limited resources. By tracking patient accrual, Clinical and Translational Science Awards hubs can identify at-risk studies and provide them the support needed to reach recruitment goals and maintain financial solvency. However, tracking accrual has proved challenging because relevant patient- and protocol-level data often reside in siloed systems. To address this fragmentation, in September 2020 the South Carolina Clinical and Translational Research Institute, with an academic home at the Medical University of South Carolina, implemented a clinical trial management system (CTMS), with its access to patient-level data, and incorporated it into its Research Integrated Network of Systems (RINS), which links study-level data across disparate systems relevant to clinical research. Within the first year of CTMS implementation, 324 protocols were funneled through CTMS/RINS, with more than 2600 participants enrolled. Integrated data from CTMS/RINS have enabled near-real-time assessment of patient accrual and accelerated reimbursement from industry sponsors. For institutions with bioinformatics or programming capacity, the CTMS/RINS integration provides a powerful model for tracking and improving clinical trial efficiency, compliance, and cost-effectiveness.
Databáze: Directory of Open Access Journals