Quality clinical research is essential for health care progress and is the mission of academic health centers. Yet ensuring quality depends on an institution’s ability to measure, control, and respond to metrics of trial performance. Uninformed clinical research provides little benefit to health care, drains institutional resources, and may waste participants' time and commitment. Opportunities for ensuring high-quality research are multifactorial, including training, evaluation, and retention of research workforces; operational efficiencies; and standardizing policies and procedures. Duke University School of Medicine has committed to improving the quality and informativeness of our clinical research enterprise through investments in infrastructure with significant focus on optimizing research management system integration as a foundational element for quality management. To address prior technology limitations, Duke has optimized Advarra’s OnCore for this purpose by seamlessly integrating with the IRB system, electronic health record, and general ledger. Our goal was to create a standardized clinical research experience to manage research from inception to closeout. Key drivers of implementation include transparency of research process data and generating metrics aligned with institutional goals. Since implementation, Duke has leveraged OnCore data to measure, track, and report metrics resulting in improvements in clinical research conduct and quality.

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.