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

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.

Drivers of Start-Up Delays in Global Randomized Clinical Trials.

BACKGROUND: Global, randomized clinical trials are extremely complex. Trial start-up is a critical phase and has many opportunities for delay which adversely impact the study timelines and budget. Understanding factors that contribute to delay may help clinical trial managers and other stakeholders to work more efficiently, hastening patient access to potential new therapies. METHODS: We reviewed the available literature related to start-up of global, Phase III clinical trials and then created a fishbone diagram detailing drivers contributing to start-up delays. The issues identified were used to craft a checklist to assist clinical trial managers in more efficient trial start-up. RESULTS: We identified key drivers for start-up delays in the following categories: regulatory, contracts and budgets, insurance, clinical supplies, site identification and selection, site activation, and inefficient processes/pitfalls. CONCLUSION: Initiating global randomized clinical trials is a complex endeavor, and reasons for delay are well documented in the literature. By using a checklist, clinical trial managers may mitigate some delays and get clinical studies initiated as soon as possible.