The implications of real-world data integration in health care and ophthalmology

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The FDA recently released a final guidance on the use of real-world data (RWD) for regulatory decision-making.

The guidance represents a pivotal step forward for the eye care industry, promising to foster innovation in medical research and improve patient outcomes through more informed regulatory decisions.

Sujay Jadhav, CEO of Verana Health, provided an overview of the guidance. He told Ophthalmology Times the FDA is emphasizing the integration of real-world data and real-world evidence in regulatory decision-making processes. Additionally, the guidance outlines the standards and considerations for using data derived from real-world data sources like electronic health records (EHRs), medical and pharmacy claims, and patient-generated data from various apps and devices.

Jadhav said the guidance is “aimed to ensure the reliability and quality of real-world data, promoting its use and supporting regulatory submissions and decisions related to drug approvals, safety monitoring, and post-market surveillance.”

According to Jadhav, some of the benefits of integrating real-world data into regulatory decision-making are that it enhances decision-making and provides comprehensive insights into how drugs perform in broader populations beyond the controlled environment of clinical trials. Other benefits include increased efficiency and the ability to capture data from diverse patient populations, which Jadhav said are often underrepresented in traditional clinical trials and can now bring more awareness to equity issues in health care.

However, there are challenges to using real-world data in health care as well.

“Ensuring that real-world data is accurate, complete, and consistently formatted across different sources remains still a challenge,” Jadhav said. “Privacy and security, protecting patient privacy, and securing sensitive health data are critical concerns when handling large volumes of real-world data. Although there are improvements from a technology perspective, this is still an area that continues focus, which is needed. Integration and standardization, harmonizing data from various sources to create a cohesive data set that meets regulatory standards can be complex.”

The FDA will ensure the quality and reliability of data by making sure submissions they receive that use real-world data are aligned with the guidance.

For ophthalmologists, Jadhav says that they can contribute to the integration of real-world data by recording detailed and accurate patient data in EHRs, engaging in patient registries, and collaborating with research institutions by participating in studies that utilize real-world data to generate new insights and improve patient outcomes. Regarding the impact real-world data integration will have on practices, Jadhav is optimistic.

“I think one of the biggest impacts we'll be around helping streamline approval processes for new drugs and devices,” Jadhav noted. “Additionally, real-world data offers data-driven insights that can enhance patient care by improving patient management strategies, so these improvements collectively contribute to more effective and efficient ophthalmology practices.”

Additionally, Jadhav said real-world data could decrease the time it takes to bring new drugs to the market, making the trial process more cost-effective. Clinical trials could also transform their design by “providing a more comprehensive view of drug efficacy and safety.”

“This holistic approach I think will enhance the understanding of how treatments perform in a real-world setting,” he pointed out. “Additionally, real-world data can help support the development of adaptive trial designs that can adjust in real-time based on emerging insights, making trials more flexible and responsive to new information, which can improve their efficiency and outcomes.”

Looking ahead, real-world data could be expanded beyond regulatory decision-making, but also in post-market surveillance and health policy formation, which Jadhav said he believes can play a critical role in shaping the future of health care and improving patient outcomes by providing more.