OnCore Clinical Research Management
In addition to centralizing cancer clinical trial resources and processes, all National Cancer Institute-Designated cancer centers are required to carefully and consistently track trials from start to finish. As a result, a primary task of the CTO Implementation Project team was to research, select, and specify the best tracking and monitoring software available.
The OnCore Clinical Research Management (CRM) by Forte Research Systems is a secure centralized system for tracking clinical research. It’s a key tool for more effective and efficient management of clinical cancer trials at MCW. OnCore adds increased effectiveness and efficiencies to all protocols including, patient tracking, clinic visit tracking, accrual reporting, internal auditing, and sponsor billing.
While still in the early stages, the software will have a huge impact on how trials are managed and data availability, accuracy, and accessibility.
Sandi Johnson, MA, Clinical Research Management System Coordinator, has worked diligently on the configuration choices to make OnCore the best tool for clinical trials at MCW. She explains the selection and specification process, and what benefits OnCore brings to the CTO, investigators, and MCW:
I think we looked at about five different vendors, but OnCore was a pretty obvious choice. It’s already used by about 40 NCI-Designated Cancer Centers around the country.
I think the biggest benefit of OnCore, and the CTO, is that the software and implementation project has really brought all these different departments together, pulling the best practices from each. OnCore also allows us to measure the sheer volume of work we do here. It tracks hundreds of trials and thousands of patients, and this lets us put our finger on the pulse. When we were all working in our own little areas, we really had no idea what the other departments were working on. Now we have that institutional knowledge—it’s all housed in one place. Instead of running around to try to collect data from many different sources and many different formats, ranging from Excel files, to handwritten charts, to knowledge in someone’s head, it is all in a single place, in the same format.
I think investigators will like the ability to search in the system themselves, and see all the data and trials across the institution. This has never been available before. It’s no longer just in someone’s head, or in five different places. One of the biggest benefits is that the system brings all those disparate systems in-line and houses it all in one place that is accessible to everyone.
It’s a tool to help physicians and investigators learn the new trial processes, and help them share knowledge about trials throughout the organization. It also really helps with trial management and enrollment. For instance, the system only maintains the most recent consent form, so staff and investigators will always consent patients on the right protocols – that’s a really big deal. That takes a lot of pressure off of staff.
The OnCore support staff really seem to be at our beck and call; this is very valuable during these initial months. It’s also incredibly important that Dr. Thomas and Betty understand that we need a dedicated, full-time resource to make this happen. I’m really grateful to have that responsibility, start from the beginning with something, move forward, and make it work. I tell people it’s my baby.
The system itself is very user friendly and organized really well. There is really no way that someone can go in and break it or screw up the data. It limits access and functionality by user type – it’s not like someone can go in and play around with trial protocols.
We would not be this far without Kristin Lemke (Clinical Trials Coordinator on the CTO regulatory team). It’s only with her help that we could get all of the active protocols and patients into the system. Now she’s working on entering all of the new or pending trials and then closed trials where we’re following patients. Eventually we’ll have all trial data going back to 2006. I think it's also important that people know that although the CTO is the first to utilize the software, OnCore CRM is was purchased and specified for enterprise-wide use. We worked with cardiology to make sure the software can support other types of clinical trials.
Coming in Phase Two, researchers will have the ability to create customized reports for their trials, and compile and sort data based on their needs. CTO administration will be able to quickly see all patients enrolled in trials and the date that any patient was consented. They can take the data and sort it by department, by PI, by study type, just about anything. This is something that’s never be available like this. Before, if this type of data was needed, it would literally take days and days to find where or if it existed, run around and track it down and pull it into some type of report.
It’s really an invaluable tool, and we wouldn’t have a centralized CTO without it. In these early stages there are always some frustrations and a learning curve, but as we all learn more together, the functionality will come and it will become a go-to resource just like EPIC.
It will make trials easier, better and safer, and will make us a better Cancer Clinical Trials Office.
Before coming to MCW, Sandi Johnson was the Senior Data Advisor at a CDD HIV Prevention Field Station in Botswana (2002-2008). There she selected and specified a data management system that provided the analysis needed to prove a new method to prevent HIV. Sandi and her team recently published their results in the New England Journal of Medicine.