May 19
2023
Understanding the Benefits of Data Registries for Advancing Patient Centricity and Research
By Alexandra Weiss, nonprofit strategy, patient organizations, IQVIA.
The past few years ushered in a historic wave of innovation in the therapeutic development landscape, heightening the demand for high-quality, real-world data that captures insights from across the entire patient journey. Advancements in government regulations and data technologies are dramatically improving access to electronic health information, presenting unique opportunities for patient advocacy organizations to serve as trusted data stewards.
As regulations, technology and vendor offerings continue to evolve, patient data strategies and data technology capabilities will equip patient advocacy organizations with the ability to advance research through the lens of real-world patient-centric data. In harnessing the full value of advanced data registries to collect, analyze and share information, patient advocacy organizations can better engage with patients and their communities. These tools also present an unprecedented opportunity for patient organizations to collaborate with the research and life sciences community to drive research advancements using patient-centered data that places patient needs and priorities front and center.
Navigating Changes in the Clinical Research Landscape
When discussing the value of research-grade data registries, it is critical to first consider the ways in which the clinical research industry has evolved. Landmark regulatory advancements such as the 21st Century Cures Act and draft FDA guidance on real-world evidence have accelerated the ability to access interoperable health data.
The Cures Act empowers patients with ownership of their own health data, which they can share with advocacy organizations. This provides patient advocacy organizations with access to insights for a broader scope of patients, disease experiences and treatment journeys, equipping them to play a more active role in regulatory decision making and the advancement of drug approval.
In addition to regulatory advancements, the technology and vendor ecosystems have vastly expanded. Data exchange standards such as Health Level 7, Fast Healthcare Interoperability Resources and data models such as Observations Medical Outcomes Partnership are simplifying analytic product delivery by enabling growth in the automation of data capture and data processing. There is also a broader range of commercial partnership opportunities available to help expand patient engagement and generate evidence related to care delivery and treatment responses.
Finally, patient centricity is transitioning from a general aspiration to an immediate operational priority. As patients become increasingly involved in the clinical research and care process, patient advocacy organizations are better equipped in their roles as trusted data stewards.
These advancements present new opportunities for patient organizations to build a cohesive data strategy and expand registry capabilities to capture a 360-degree view of patient perspectives while supporting patient centricity, data ownership, privacy and security.
With the right patient data registry, patient advocacy organizations can accomplish the following:
- Address research gaps and accelerate clinical developments.
- Equip patients with the information they need to advocate for themselves in their care
- Improve provider understanding of patient treatment needs.
- Help investigators ask more relevant questions throughout the clinical research process.
- Cultivate more strategic partnerships with other stakeholders in the biomedical research, medical specialty society and therapeutic development spaces.
- Facilitate more effective long-term follow-up initiatives to drive positive care outcomes.
