Systems and Regulatory Issues
Guest Expert: Kerry Bridges: The power of collaboration: Sharing data to improve accrual
Originally posted by: Linda Parreco, AccrualNet Co-Moderator, on the former AccrualNet site on Sep 28, 2010.
Please welcome our guest writer, Kerry Bridges, of the Simon Cancer Center at Indiana University. Kerry describes how the common use of a clinical trials management software system grew into a very effective collaboration. The group’s projects led to two ASCO abstracts as well as a recent citation in the August Journal of Clinical Oncology. We invite you to participate in this discussion by adding your questions or comments.
Kerry Bridges' Post:
AccrualNet is a great forum for collaboration and I wanted to share some work done by the “Onsemble Community” relating to accrual challenges, metrics and benchmarking. Essentially this community of ~27 cancer centers (NCI-designated, comprehensive, children’s) meets biannually with our software vendor. Besides using the company’s clinical trials management database, we all have an opportunity to share ideas, challenges and collaborate. After 5 years of meetings, we (Cancer Center Administrators and Managers) created our own pre-conference workshop to address staffing, metrics and obstacles to accrual. In that time, we’ve been able to analyze aggregate datasets from 16 cancer centers and found a few surprises. As presented in a poster at ASCO in 2009 looking at 7 years of data, 56% of cooperative group trials at our cancer centers had zero accrual and 51% of industry trials had zero accrual. Obviously, a huge amount of resources have been wasted not just by cooperative groups and industry but by the cancer centers as well. We also attempted to put a cost on this effort by tracking regulatory effort across cancer centers by means of surveys. How many hours does it take a regulatory FTE to open an industry, investigator-initiated or cooperative group study? Two rounds of surveys and 17 cancer center responses later, we found some very broad ranges. Median hours were 23, 29 and 14.75 respectively. We’re still trying to define and refine these numbers with a more objective tool through our CRESCENDO initiative on the web and it’s open to any cancer center. We welcome all comers. Presently, we have stages of a trial, broad categories of activities and task specific roles; e.g. regulatory, research nurse, study coordinator, finance/budgeting staff, data management and monitoring. Our goal is to develop a tool whereby we can track all activities from the point of entry of a trial to closeout. We can determine resources needed and determine accurate costs. Do we really know how much it costs to activate a trial? Other ongoing initiatives include metrics and benchmarking: time to open a trial, time to first patient enrolled resource hours required …the list goes on. This is a wonderful collaborative forum to share best practices and set realistic benchmarks. It’s nice to know we’re in good company.