Building Research-Ready Communities: A Closer Look at Patient Registries
The role of patients has evolved dramatically, from passive recipients of care to active partners in defining research strategy, noted Kim McCleary, managing director of FasterCures, at the start of our June 9 Webinar on patient registries.
A key example of this is the proliferation of patient registries, which show a great deal of promise for improving and accelerating medical research. For instance, registries can help ensure that research is focused on targets that matter most to patients, they enable the collection of quality, observational data (from demographic information to genetic details), and they can link those data with other large population databases. However, though sometimes hailed as a cure-all for overcoming research barriers, not every patient registry is created equal. Understanding the wide range of platforms, objectives, and data collected through these tools is critical to maximizing their efficacy.
Speakers Kyle Brown, founder and CEO of PatientCrossroads, and Joe Selby, executive director of the Patient-Centered Outcomes Research Institute (PCORI), shed light on proven strategies for building and upholding effective registries, and understanding what questions to ask throughout the process. The Webinar, moderated by McCleary, attracted nearly 600 registrants from across sectors and diseases.
Brown’s philosophy is that researchers can’t know what to focus on without the type of information that patient registries can collect – demographic information, genetic data, medical history, electronic health record (EHR) information, and more. Motivated patient communities can help to stimulate and answer important research questions by hosting registries; however, many communities suffer due to fragmentation of efforts. For example, the Duchenne muscular dystrophy community has more than 30 active registries collecting data from a rare disease population, with even more in planning stages.
That’s the basis of PatientCrossroads – a disease registry platform created to reduce fragmentation, collect patient data in a deliberate way, and share it back with the community. “Patients want to share their information, they want to help researchers find cures,” Brown noted. “And giving data back to patients is a strong incentive to participate.”
PatientCrossroads hosts a vast array of different registries – from organizations representing ultra-rare diseases to a Down syndrome registry working in conjunction with the National Institutes of Health – and partners with advocacy organizations to reach out to their communities. Once patient-participants are introduced to the registry platform, patient data are collected and standardized across the platform. Data can be patient-entered, physician-entered, collected from mobile apps, integrated with EHRs, and synced with genetic information. PatientCrossroads then reviews all of the entries, synthesizes and anonymizes them, and makes them searchable. This allows for studies to be run with the data and provides an opportunity for clinical trial recruitment. It also permits research questions to be posed and answered across different disease communities through the shared infrastructure.
Selby then introduced PCORNet, the National Patient‐Centered Clinical Research Network, initiated by PCORI. Presently, PCORNet has 29 patient-powered research networks (PPRNs) involving 155 organizations and 3,000 collaborators. It represents an approximately $275-million investment by PCORI, which was established by the Affordable Care Act to close the gaps in evidence needed to improve key health outcomes by gathering patient input into research questions. PCORI is making an immense investment in PCORNet and has registered upwards of 70 million people via this network to date. The registries in PCORNet help patients contribute to research, link EHR data to research data, and deepen researchers’ engagement with patient populations. “Registries are the backbone of the PPRNs, and span a range of about 100 different conditions,” said Selby. He went on to explain how the PPRNs are not only collaborating with each another, but also with the Clinical Data Research Networks on research ideas, technology innovations, and enrollment approaches for registries, creating more collaborative communities.
For groups considering building/launching a new registry, the panelists suggest asking these key questions:
- What are the intended uses of the registry?
- Will you consent registry participants? What consents will you obtain?
- How will you obtain EHR data? Claims data? Patient‐reported data? Biospecimens?
- How will you engage researchers, clinicians, and patients?
FasterCures continues to track this growing field and the potential that it has for advancing the science of patient input. As groups further explore these questions and takeaways, we anticipate future registries will continue to reveal more detail about the individual patient experience as well as representative community experiences.