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The center looks to Oracle to support translational research and accelerate the development of personalized cancer care.
Moffitt Cancer Center's focus on personalized medicine created the need for an advanced health science analytics platform and the subsequent investment into Oracle's integrated suite of solutions. In search of the foundation for its next-generation health and research informatics systems that would leverage its existing Electronic Health Record and biobanking samples processes, Moffitt sent out for seven requests for concept. "It was clear that Oracle's vision, with Enterprise Health Analytics, and the Healthcare Data Model was most closely in line with our vision," said Mark Hulse, Vice President, Information Technology, Chief Information Officer at Moffitt Cancer Center.
"Total Cancer Care (TCC) is the model for how we treat and think about a patient's journey through the disease," explained Hulse. To that end, Moffitt asks a vast majority of its patients if they are interested in consenting to the Total Cancer Care protocol. This allows the patient's experience, in the form of data, to be captured in a longitudinal study throughout the patient's life. To date, Hulse says they have over 73,000 patients in the study.
A major part of the Total Cancer Care protocol is M2Gen, a wholly-owned for-profit subsidiary of Moffitt, that manages the clinical data, biobanked tissue samples and molecular data from consented patients. To date, there are 37,000 tissue samples, 17,000 of which are molecularly profiled using genetic expression and other sequencing techniques. The goal of M2Gen is to deliver on personalized medicine through the use of high quality tissue, clinical data, and molecular technology to advance personalized cancer research and treatments through the combination of public and private partnerships including other healthcare delivery and life sciences organizations.
With data and tissue from the 18 hospitals that have agreed to participate and enroll patients in the Total Cancer Care protocol, there is now a need to implement a next-generation Health and Research Informatics platform. "All parties need access for different reasons," explained Hulse. "Scientists for research, clinicians for outcomes and staging, and for translational medicine to bridge those two worlds."
For Moffitt, Oracle's solutions offered the data warehouse and the data model that can link the clinical data with the molecular data. The front-end data comes from disparate sources. Informatica is used to transform and curate the data as well as capture the associated metadata. Another specific tool is Transmed, which allows researchers and clinicians to work with the data in a highly visual way, and perform advanced analytics.
Eventually, the physician will be able to use these analytics to make decisions on patients' treatments.
In the area of clinical trials, the key to the technology behind Total Cancer Care is to reduce the amount of time it takes to enroll patients. Dan Sullivan, MD, Executive Vice President and Associate Center Director for Clinical Investigations at Moffitt, explained that the current process is to find patients from the TCC database that have the type of cancer or stage currently needed for the trial. Then, they use short forms to find out the current status of the patient regarding eligibility and recontact the patient for the trial. With this approach, the Moffitt Cancer Center recently enrolled 37 patients on a Phase II trial using a CTEP agent in four months with the TCC database; the entire trial, from LOI submission to treatment of the last patient, was performed in 10 months.
"We need to shorten this process to get the patient clinical data in real time from the affiliates," said Sullivan. That real-time data would narrow down the patient's inclusion/exclusion criteria and would include, for example, creatinine and bilirubin levels, platelet count, and performance status. It is anticipated that Oracle will help provide solutions for the collection of these real-time data from TCC Consortium members. After matching patients to trials using general eligibility criteria, the next step is to match the tumor's molecular characteristics to novel anticancer agents using specific biomarkers. Sullivan believes trial matching performed this way, with enriching through targeted molecular data, could shorten time lines and require fewer patients. Specifically, he said these trials could require only 20 to 25 patients for a single-arm Phase II trial, vs. 40 to 50 for a traditional single-arm Phase II trial, or 100 to 120 in a randomized Phase II trial.
Neil de Crescenzo, Senior Vice President, General Manager, Oracle Health Sciences, explained the three data buckets that provide insights into healthcare are the EHR, clinical trials, and observational data. "Moffitt is an advanced institution. EHR is important, but what about the other data buckets in regard to patient care, treatment, and diagnosis. What they are doing is information management for the future."