Flatiron Health is expanding its efforts to make oncology clinical trials more accessible and representative by focusing on pragmatic trial designs and leveraging technology to reduce operational burdens on community practices.
Addressing Barriers to Clinical Trial Access
A nationwide study by Flatiron Health highlighted that patient groups treated at community practices with limited access to oncology clinical trials are often underrepresented in such trials. The study, published in JNCI Cancer Spectrum, analyzed data from 550,000 cancer patients across 178 community oncology practices. Ivy Altomare, M.D., Head of Research Oncology, Clinical Research at Flatiron Health, noted that the likelihood of research engagement significantly declined with practice size, suggesting that smaller practices lack the resources to sustain clinical research programs.
The Pragmatic Approach
Neal Meropol, Vice President of Research Oncology at Flatiron Health, emphasizes that the primary barrier to clinical trial participation is access to studies within patients' care settings. Flatiron Health advocates for simplifying trial operations and designs to better suit community-based practices, making them "look more like routine care." This involves loosening strict eligibility criteria, minimizing extraneous data collection, and implementing technologies for direct data transfer from electronic health records (EHR) to study databases.
Technology as an Enabler
Flatiron Health, which operates the OncoEMR, is focused on providing technology solutions to oncology practices across the U.S. Flatiron’s tools, including Flatiron Clinical Pipe, facilitate the automated transfer of study data from EHRs to research databases, reducing data entry burdens and minimizing errors. According to Meropol, this technology reduces the time and effort associated with data management in clinical trials, thereby lowering monitoring-related costs.
Collaborative Efforts and Future Directions
Flatiron Health is aligned with the FDA's Oncology Center of Excellence and its Project 5 in 5 initiative, which aims to crowdsource ideas for large pragmatic studies. Meropol co-chaired the National Cancer Institute’s Streamlining Clinical Trials Working Group, which recommended further testing and implementation of tools for extracting clinical trial data from EHRs.
Altomare emphasizes that solving the trial access problem requires a multi-pronged approach, including sponsors changing trial designs and providing funding to support community clinics. Flatiron Health offers a comprehensive package of products and services to sponsors, including simplified data entry, EHR-derived data for site selection, and improved patient identification.
Flatiron Health partners with the American Cancer Society to offer a Real-World Data Impact Award, promoting research using Flatiron data to improve health equity and address systemic issues in cancer care. Meropol concludes, "It is a societal imperative to increase access to clinical trials for all patients wherever they receive their care such that everyone has the opportunity to participate in improving the outcomes for people with cancer."
