At this point, it’s not a surprise to say that data is power – particularly when it comes to advancing clinical research, furthering innovation and improving patient care.
Tools such as wearables can provide a holistic view of a patient’s care journey beyond information gathered in a clinical visit. Still, experts say that network-wide availability of patient-generated health data is still lacking.
Adam Mariano, vice president of Health Innovation at IQVIA, and David Voccola, senior director of global strategic planning for the integrated health practice at IQVIA, discussed the importance of having a variety of data sources, what needs to happen to make patient-generated data more readily available for researchers and how this data can impact innovation in care delivery.
Q. Why is it so important to have a variety of data sources when it comes to clinical research and development?
A. For generations, the data available for clinical research and development has been rate-limited by the cost and effort associated with having human beings abstract relevant information from clinical systems into case report forms. Transitioning these forms from paper to electronic data capture did not change the base function in any significant way and continues to leave large amounts of potentially relevant information on the shelf.
While the advent of modern interoperable approaches is gaining attention by reducing data entry burden – such as through pre-population of eCRFs using electronic health record data – the available data is still limited to a participating site’s point-in-time interactions with a given patient.
The real game-changer in the United States is the advent of interoperable patient-mediated and patient-generated data sources, which can serve to provide much higher resolution and more holistic views of the patient’s care journey, whether the relevant data was generated at a protocol visit at a participating site, during routine primary care, an acute care encounter or even at home.
This ability to expand the research aperture to harmonize a rich, longitudinal view of relevant health data from across the care journey has the potential to improve upon any clinical research endeavor and will become increasingly important to the success of novel products (such as cell and gene therapies), requiring follow-up periods extending to a decade or longer.
Q. How can data diversity contribute to health equity?
A. A key factor in reducing health inequity is generating data that proves its existence and measures its reduction. Care delivery and payment snapshots are necessary, but insufficient, components. Increasing data diversity – to include patient-generated and population-based information – would allow us to honestly examine patient outcomes while better controlling for social determinants of health and patient experiences.
And when we understand more of the nonclinical reasons participants do or not succeed in clinical research engagements, we can reduce bias in research participation, have more representative data available for regulatory decision-making, and generate more equitable outcomes in care delivery.
Data diversity improves equitable access to care and exposes obstacles to that access in a quantifiable and timely fashion. This moves beyond theoretical and retrospective analysis into a realm where data can be used in a near real-time fashion to reduce obstacles to access and quality care, as well as offering pathways to rapidly improve outcomes.
Q. What’s currently lacking when it comes to patient-generated data availability in a shared data network environment? Why is this the case?
A. Several things will be needed before we will see network-wide availability of patient-generated data, including:
- Standards-based collection for Patient-Reported Outcome and other Clinical Outcome Assessment data to ensure greater acceptance of digital biomarkers.
- More consistent patient access to broadband Internet across socioeconomic boundaries.
- Trust-building exercises with traditionally underserved populations and communities of color who have not always had positive experience with U.S. healthcare.
Patients are an essential source of outcome data, yet patient-generated data is still rarely included in quality measures, capitated care contracts or reimbursement decisions. Making patient-generated data mandatory in any of these areas will significantly improve healthcare ecosystem investments in closing the listening gap.
Q. What needs to happen to make patient-generated data more readily available for researchers and innovators?
A. The increasing ubiquity of healthcare data standards, like HL7 Fast Healthcare Interoperability Resources in care delivery, research and even consumer spaces is empowering a new generation of interoperable use cases leveraging both clinic- and patient-generated data.
Likewise, the standardization of common social determinants and other patient-reported data (thanks to the Gravity FHIR Accelerator Project and similar efforts) are critical to move this forward. The rapid adoption of these types of standards, mandates for inclusion of this data in pragmatic and real-world data sources for clinical trials/studies, and expansion of quality measures for health systems and payers to include social determinants facets are all practical paths to including this.
Additionally, creating easy pathways (such as digital health wallets) for patients to collect and share this data, as well as continuing to push providers and payers to expand the breadth and quality of required data sharing regulations under the 21st Century Cures Act, will continue to drive utilization of these methods, making data more readily available to both researchers and innovative players.
Q. How can patient-generated data help inform regulatory decision-making and impact innovation in care delivery?
A. Standalone patient-reported data has traditionally been underutilized in both care-delivery and clinical research settings. Part of the rationale behind this has been the difficulty in verifying patient-reported data at scale using companion data from clinical or administrative sources, but the ability to create a verifiable, holistic view of patient-reported events is quickly becoming reality in the United States.
For example, rather than ask a participant to monitor their daily blood sugar with finger pricks and report the results in a form-based PRO diary, patients could instead mediate the sharing of data directly from a wearable continuous glucose monitor. This would both reduce burden for the patient and provide verifiable device data to accompany the rest of the accompanying PRO data.
This model unlocks more granular and longitudinal views of treatment outcomes by incorporating high-resolution patient-generated and patient-reported data using methods that are appropriate for regulatory decision-making.
The same is true in care delivery, where the ability to pair patient-generated and/or reported data with secondary data from care delivery has the potential to revolutionize decision support, quality improvement, and digital guideline development. More importantly, adding weight to these patient-based data sources for regulators, health systems and payers will drive demand to elicit more feedback from patients and build programs around this holistic data view.
When patients and industry goals are aligned, everyone – but most importantly patients – stands a better chance of experiencing a positive outcome.
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