Electronic Health Reporter

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 21^st 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.

Evolving the Role of Patient Advocacy Organizations

While the traditional purpose of a patient registry remains the same, the number of use cases has expanded significantly. Historically, patient registry use cases were leveraged for basic scientific research, including biomarker discovery, clinical research and surveillance, healthcare quality improvement, and policy and advocacy. In the past, a registry may have taken a site-based data capture or patient-reported survey approach. The reality is that traditional registries are unsuitable for managing the multiple dimensions of health data that are increasingly relevant to healthcare improvement.

With the changes in the landscape outlined above, organizations are now able to leverage a multifaceted data collection approach that includes site-based, patient-mediated, PROs, and genomics/test results, to provide an expanded view of the patient and disease never before seen or understood.

Today, many health systems are taking a learning approach, where practice informs research and research informs practice. Learning health systems employ a continuous loop to identify outcomes, measure, analyze, recommend and implement change, and improve care delivery. Now, instead of donated data only supporting future patients, it can impact patients in the present.

A contemporary patient registry reduces the friction within the move from measurement to analysis by using curated data assets designed to address a predefined class of research questions. In this case, data is acquired, mapped, curated, enriched, transformed or repurposed, and delivered back to the health system for analysis. This enables analytic datasets to be generated in days as opposed to months or years.

With a modern data registry, patients are able to generate massive quantities of data and digital biomarkers into their own overall health record. Combining human and data interaction at such a scale allows patient advocacy organizations to deliver the right types of data to therapeutic investigators, leveraging AI to generate insights.

In developing new registry programs and data strategies, patient organizations should consider the following best practices:

• Seek guidance from other experienced patient organizations
• Ensure meta-data alignment and standardization
• Build partner networks and invest in community building
• Ensure organizational alignment on data governance models
• Support value generation with real-world evidence by offering detailed specifications on what kind of data are in the registry and in what form

 Looking Ahead to Better Health Outcomes

The therapeutic development industry has reached an inflection point—gone are the days where practitioners, advocates, and researchers must learn about patients through tiny disease-shaped windows. These stakeholders now have the opportunity to follow patients on their care journey and develop a greater understanding of their clinical experience, their burdens, and how to better alleviate these challenges.

The accurate collection of patient data is critical to both improving health outcomes and sharing information among those affected by a disease. By modernizing and enhancing their data strategy and registries, patient advocacy organizations can facilitate the exchange of critical information with and among those affected by a disease, cultivate partnerships with pharmaceutical companies and other research organizations, and ultimately improve health outcomes for the patients they serve.