Patient-Generated Health Data: The Key to Clinical Innovation

By Alexandra Weiss

Clinical innovation is more patient-centric and data-rich than ever. The biomedical research and development industry almost universally agrees that aggregating and analyzing shared data is essential to the accuracy of clinical research, development, and care. Although data from randomized controlled trials remains the gold standard, infrastructure for sharing data from a variety of sources is growing through use of electronic health records, mobile health devices, registries, and claims.

Expanding tools for patient-centered drug development can capture a fuller patient experience

While the COVID-19 pandemic complicated patient data collection, mass closure of clinical trial sites ultimately propelled the adoption of more agile methods for capturing patient data remotely. Data collected via technologies such as smartphone apps, patient registries, wearables, online communities, and social media can provide a more comprehensive picture of the impact of disease and treatments and give deeper context to other data. Stakeholders have reevaluated how patient-generated health data can improve outcomes by capturing a more comprehensive view of the patient experience inside and outside the clinic. This data can provide insights on patient well-being between medical visits, information for use in shared decision-making for preventive and chronic care management, potential cost savings, and improvements in quality, care coordination, and patient safety. Not only do stakeholders recognize the many benefits of a patient-centric model, but patients prefer it as well—the model positions them as partners, rather than subjects to be studied.

But even as providers, product developers, researchers, and regulators alike recognize the considerable value of patient-generated health data, these vital data insights have generally not been available in the environment of shared data networks. Historically, patient-generated health data tends to be collected and controlled by providers and researchers, gathered infrequently, siloed by third-party vendors, inaccessible to patients, and rarely driven by patients’ interests and priorities. This not only stalls clinical innovation and product development, but also leaves patients discouraged that their time and input is not being routinely considered to advance research and improve their care.

Fortunately, the 21st Century Cures Act, Cures 2.0, is rapidly shifting the methods of patient research and care. Between these new U.S. federal regulations and modern health informatics capabilities, the balance of influence in clinical and observational research between healthcare sites, patients, and funders is fundamentally changing. This presents an opportunity for patient advocacy organizations to act as trusted data stewards on behalf of their communities. In this role, such organizations can support patients in managing their care, aggregate multiple data sources to drive research, and help put the patient’s voice at the center of study design and care delivery.

The role of patient advocacy organizations in the changing healthcare system

Across every disease area, countless individuals and families struggle to navigate their unique medical journey, interacting with a wide range of technologies, health systems, and third parties in hopes of improving their quality of life. Given recent regulatory and technological progress, patient advocacy organizations should consider several emerging factors as they leverage data and engage with patients, clinicians, and researchers:

  • Patient data ownership: Gone are the days of clinical sites gatekeeping patient data. In the U.S., patients and their loved ones are now the principal owners of the electronic health information generated about them by care providers, payers, and consumer medical devices—and new tools are allowing patients to directly access and share this data with trusted organizations.
  • Advancements in technology: The modernization of technology is equipping healthcare systems with the tools to engage with patients and integrate disparate data types on a national scale. As more data is collected and aggregated at a broader scale, more opportunities will emerge for clinical innovation.
  • Rising acceptance of consumer devices as tools for data collection: The COVID-19 pandemic drove the development of more agile tools to help capture patient data in a remote capacity. As a result, the life sciences industry has adopted new methods of collecting patient data, including the “bring your own device” model. Patient-generated data can now be linked and integrated into a patient’s broader data profile, creating a more holistic view of the patient experience.
  • Changes in stakeholder priorities: Regulators and payers are increasingly seeing the value of real-world data, which is creating growing demand for patient data across the drug life cycle. Additionally, new therapy types and changes in trial approaches and requirements are driving stakeholders to explore more innovative, cost-effective, and long-term approaches to follow-up. All in all, stakeholders are beginning to recognize that patient centricity is essential to the success of clinical innovation.

Patient advocacy organizations must consider these industry shifts when fighting for patients and investing in patient and research initiatives. While the complexities of the healthcare system can be overwhelming, these organizations can help patients ensure that their data is leveraged to return value to their care and treatments through accelerated product development, informed regulatory decision-making, and innovation in care delivery.

Patient advocacy organizations: The liaison for patients and innovators

Clinicians, researchers, and innovators are left with an incomplete view of the patient experience and lack the context needed to improve patient care when they don’t have patient-generated health data. Ultimately, when patients are given a seat at the table, all stakeholders benefit. Patients need to be recognized as contributing partners in decision-making processes both at network and local levels, rather than just trial subjects. Thus, stakeholders must ensure they are providing value back to patients to incentivize their sharing of this critical data. Through their role as a trusted resource for patients and a source of insight for innovators, patient advocacy organizations are uniquely positioned to further the advancement of patient-generated health data as a means for clinical care and innovation.

Alexandra Weiss is director of strategic operations, patient advocacy at IQVIA.