The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study

Dinesh Pal Mudaranthakam, Alexandra Brown, Elizabeth Kerling, Susan E Carlson, Christina J Valentine, Byron Gajewski, Dinesh Pal Mudaranthakam, Alexandra Brown, Elizabeth Kerling, Susan E Carlson, Christina J Valentine, Byron Gajewski

Abstract

Background: As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties.

Objective: The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management.

Methods: A National Institute of Child Health and Human Development-funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization.

Results: Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates.

Conclusions: The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials.

Trial registration: ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj.

Keywords: accrual; accrual inequality; clinical trials; cost; data management; data quality; health care; health operations; healthcare; metrics; rare diseases; trial execution.

Conflict of interest statement

Conflicts of Interest: SEC has received honorariums for presentations about DHA in infancy and pregnancy. CJV is an employee of RB Nutrition, which produces infant formulas and supplements; however, RB had no involvement in the study execution or analysis. She conducted this study through her role as an adjunct professor at the University of Cincinnati. The other authors have no competing interests.

©Dinesh Pal Mudaranthakam, Alexandra Brown, Elizabeth Kerling, Susan E Carlson, Christina J Valentine, Byron Gajewski. Originally published in JMIR Formative Research (https://formative.jmir.org), 22.12.2021.

Figures

Figure 1
Figure 1
Architecture diagram.
Figure 2
Figure 2
Accrual prediction plot; accrual prediction with visualization plots to demonstrate the predicted completion date with a 95% prediction interval and the posterior predictive distribution. Redline represents the study deadline. The black line represents the current accrual rate.
Figure 3
Figure 3
Automated weekly pharmacy refill report. DHA: docosahexaenoic acid

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Source: PubMed

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