How can better use of patient data improve health equity? Adam Mariano, Esq., MSPH, Senior Director, Product and Strategy, Integrated Health Practice at IQVIA, discusses with Evidence-based oncology TM (EBO) how the changing landscape in data ownership may allow greater use of data from groups that have historically been underrepresented in clinical trials. Changes brought about by the 21st Century Cures Act1 and the Patient Access Rule2 create an important role for patient organizations, Mariano said.
EBO: What is the role of patient organizations in obtaining data?
Mariano: The shift in data ownership in the United States, driven by the Cures Act and the Patient Access Rule, offers patient organizations a real opportunity to educate patients about their access rights, to provide context for data raw health data and to create clear pathways for patients to use this data in their care. Plain language explanations of electronic medical record data elements, advocacy services and support, and training on data access and retrieval are all critical.
EBO: How can patient organizations play a role in collecting data from underrepresented populations in clinical trials?
Mariano: Patient organizations can act as advocates for underserved and historically excluded populations by starting with education and supporting access, including educating patients about their rights, the scope of data available to them, and how to ensure this access. of data. In addition, they have the opportunity to create new creative and innovative interactions for this data once it is secured, as well as foster partnerships with other healthcare organizations to help patients apply this data in everyday healthcare transactions, also help them protect their privacy and stay informed in an increasingly crowded space.
EBO: How does interoperability improve the ability to combine data from different sources to obtain meaningful insights?
Mariano: By reducing the level of effort, complexity, high cost, and long processing time, true interoperability—and the proliferation of standards such as Level Seven Healthcare Rapid Interoperability Resources—allow faster paths to integration and knowledge. Standards-based integration, clear encoding/mapping expectations, common identifiers, and a clear range of minimum expected data sources, including those promoted by the United States Interoperability Core Data and others, allow predictable processes and data sources, increased ability to favor automation over human curation, and a focus on data enrichment over quality management.
EBO: How will patients benefit from increased data sharing?
Mariano: Patients will always benefit from data transparency. Improved portability of care, user-friendly and consumer-friendly pricing transparency, easy pathways for patient education, and reduced barriers to care are all benefits of increased patient data sharing. All of this leads to greater patient agency and improvements in patient-centered care.
EBO: Can you discuss the potential of data collection in oncology to improve health equity?
Mariano: When data collection is focused on providing representative data sets, especially those representing historically underserved and excluded populations, the opportunity for equitable treatment and cure increases. This in turn accelerates access to innovative treatments and care in these populations, and shortens the delays that have been imposed by the non-representative development of drugs and treatments. These historical delays have led to requirements for additional safety and other data collection before these at-risk populations have knowledge of treatment data and differentiated outcomes. This slows the delivery of critical oncology assets to high-risk populations. Data collection done right is a critical tool to help guide equitable care.
EBO: Want to add something else?
Mariano: Where we stand today—at the intersection of cancer research, adopting real-world data to drive breakthroughs, and patient-centered care—presents an opportunity for patient advocacy organizations to act as a trusted data steward for all patients. In this role, patient advocacy organizations can support patients in managing their care, aggregate multiple sources of data to advance oncology research, and help put the patient’s voice at the center of study design and delivery. , ensuring that these resources are accessible to all patients.
1. The 21st Century Cures Act. HR 34, 114th Congress (2016). Accessed July 11, 2022. https://www.gpo.gov/fdsys/pkg/BILLS-114hr34enr/pdf/BILLS-114hr34enr.pdf
2. Patient interaction and access data sheet. News release. CMS; March 9, 2020. Accessed July 11, 2022. https://www.cms.gov/newsroom/fact-sheets/interoperability-and-patient-access-fact-sheet