There is a significant growing demand for data evidence in cancer drug development today. Large patient-level data sources are collected as medical records or insurance claims. The data elements are processed to gain new insights; information derived from electronic health records is a source of clinical evidence generated from de-identified real-world data as a part of routine care rather than through a prospective randomized clinical trial. Although clinical trials are vital to the drug development process, they present certain limitations. For instance, it is expensive and lengthy with molecular characteristics being used to categorize cancers into subgroups too small to sufficiently populate a randomized study. Furthermore, the enormous evidence gap cannot be met via the historical approach to evidence development, which focused solely on prospective clinical trials.
Analysis of data can generate evidence to address many of the questions now arising in cancer care and therapeutic development. Using real-world evidence, doctors can learn from every patient by using information obtained during routine care. That being said, the care of nearly all cancer patients is documented in an electronic health record. However, electronic health records are not designed for research purposes and to make sense of information in electronic health records; it is necessary to use both the structured data such as height, weight, and chemotherapy regimens and the unstructured data that are locked in the electronic health record.
Flatiron Health provides a technology-enabled abstraction process to generate real-world evidence for cancer treatments. The technology-enabled abstraction can efficiently locate particular data in an electronic medical record, and then tee it up with human abstractors, including nurses and certified tumor registrars, who extract the information. The company enables centralized training for the client’s abstraction workforce and populate models with clean data elements used to answer the research questions.
Inspired by personal experiences with the illness in our families, we always believed that cancer wouldn’t be solved by the healthcare community alone; it also needed close collaboration from the industry leaders working together hand in hand
An Innovative Oncology-Specific Platform
Flatiron’s goal is to accelerate cancer research and improve patient care by enabling medical professionals and care providers to leverage this platform and learn from the experience of each patient to further the development of new treatments. The company’s biggest challenge was finding a way to convert the unstructured data—low-resolution PDF lab reports, audio files, and digital copies of hand-written notes— into structured data.
Flatiron’s cloud-based platform captures and organizes both structured and unstructured oncology data from diverse source systems such as laboratories, research repositories, and payer networks, among others. The Oncoanalytics engine pulls out relevant insights from unstructured data, which, when combined with electronic medical records (EMR) data, generates real-world evidence. Through its innovative approach, the company addresses important issues such as improving clinical trial results, optimizing the process of clinical trial eligibility assessment, and enable pharmaceutical companies’ to implementing and on-board next-gen technologies.
The fully-interoperable platform suite includes a range of product offerings—OncoEMR, OncoBilling, OncoAnalytics and OncoTrials—aimed at streamlining the workflow in cancer clinics and aggregating actionable data from to share with pharmaceutical companies and research institutes.
That being said, to optimize these processes, Flatiron uses a hybrid human-machine learning model; data is gathered using an automated collection process compared to data collected by hand from a team of 50 nurses. This hand-collected data represented a training set that could be correlated against the software-generated information to identify discrepancies, from which the algorithm could learn and improve on its accuracy. The result is an EMR system that enabled oncology practices to easily transition from time-intensive and legacy EMR to an oncology-specific platform optimized for efficiency. The OncoEMR data is matched with patients on clinical trials in partnership with the National Institutes of Health (NIH) and to support the product’s own utilization management capabilities.
Another constituent of the platform—OncoBilling— has a built-in EDI with national clearinghouse; the software generates claims, financial reports, and auto-allocate payments. In addition, the OncoBilling allows a medical professional to review claim status and ERA in real-time, ensuring referrals & authorizations within OncoEMR flow directly into the claim.
Oncology clinical trial programs are becoming increasingly complex; making it more difficult than ever to find eligible patients. To effectively manage the trails of a patient population, providers must be able to define the population who are most appropriate for their practice.
The company offers, OncoTrials, a tool powered by EHR data and built specifically for clinical research teams to identify and screen patients for clinical trials efficiently. The solution aims at reducing screening volume with eligible patients surfaced at the right time and tracking patients with automated flagging of the ineligible patients. This centrally manages the provider’s clinical trial portfolio and output detailed patient logs from initial patient identification to trial completion, which will help understand and improve research program performance with operational reports.
A value-based care program
Value-based reimbursement programs are rapidly changing the Oncology care delivery. Flatiron’s Oncology Care Model (OCM) is one of the first CMS specialty models aimed at improving quality and reducing the cost of care. The five-year voluntary, value-based care program comprises of nearly 200 oncology practices and 16 payers. The clinically-integrated OCM is powered by the firm’s OncoCloud platform and is focused on saving practice time by reducing administrative burden.
OCM practices are committed to helping push cancer care forward using deeply integrated technology solutions and trusted partnerships for long-term success such as Identifying eligible patients directly at the point of care within OncoEMR to ensure appropriate on-boarding, care coordination and MEOS billing. The model creates prints and sends a care plan to the patient portal in minutes that contains the 13 components of the IOM Care Management Plan automatically pulled from existing OncoEMR workflows. Monitoring of OCM quality includes measuring performance in near real-time and downloading registry-ready report. In addition, the OCM helps clients understand their total cost of care using claims data.
A milestone for the Oncology Community
Flatiron’s organized and accurate datasets, combined with its data analytics infrastructure, is valuable for oncology R&D efforts across the whole life sciences industry. The firm’s OncoCloud suite is built to meet the technology needs of the community practice of the future—to be operationally efficient and prepared—OncoEMR, OncoBilling, OncoAnalytics, and OncoTrials to thrive in the world of value-based care. With over 2,500 clinicians across 800 sites implementing the platform, the OncoCloud Suite has been ranked “the best end-to-end oncology technology solution” by Black Book Research and was “top-rated for overall satisfaction” by KLAS 2019 Medical Oncology Performance Report. Flatiron has since launched several applications and services to help these practices thrive. Forging ahead, the company is closely collaborating with organizations such as the Food and Drug Administration, the National Cancer Institute and others to advance the industry’s adoption of real-world evidence and new models of research in cancer. “Inspired by personal experiences with the illness in our families, we always believed that cancer wouldn’t be solved by the healthcare community alone; it also needed close collaboration from the industry leaders working together hand in hand,” concludes Turner.