The Real Value of Real-world Data

by Amanda Conschafter, blog editor

Real world data (RWD) provides valuable insight for improving health care, a new report from the Galen Institute contends. But accessing that data for the purpose of research, drug development, clinical trial enrollment and improving health care delivery proves difficult. As “Real World Data and its promise for medicine and research,” explains, this information typically falls under strict federal privacy laws. Finding a policy solution requires striking a delicate balance between maintaining privacy and culling essential data. The result could well be better patient access and improved overall health care solutions.

RWD may include patients’ first-hand information, providers’ electronic health records, and public and private payment plans’ payment data. With this information, researchers can analyze how to increase health care delivery’s efficiency, improve outcomes and eliminate redundancies. These analyses have powerful implications for real-world medicine. They can facilitate more informed care choices, more precisely designed clinical trials, and better monitoring of specific treatments.

In addition to information about the use and usefulness of treatments for patients, RWD can also include payment data. In fact, a movement toward more transparent payment information is gaining traction – evidenced in part by the Health Care Cost Institute. The institute recently announced plans to combine and publish clear claims information from multiple insurers. Meanwhile, the federal Patient -Centered Outcomes Research Institute funds programs whose databases highlight information on specific disease areas. And prescribing information continues to prove a valuable source of RWD, though not all prescribing information is available. The Centers for Medicare and Medicaid Services still deny commercial entities access to Medicare Part D prescribing information, even for research purposes.

Members of Congress have taken note of RWD’s value, particularly through the House Energy and Commerce Committee’s “A Path to 21st Century Cures” initiative. (Read IfPA’s blog on the initiative here.) But fully realizing RWD’s potential requires broad collaboration among hospitals, health care plans, pharmaceutical companies and technology firms, the Galen Institute explains. And that’s no small task.

Stakeholders must also address the protection of personal information, a formidable obstacle to accessing RWD. Galen Institute suggests the use of standard, strict contractual agreements. It also offers several potential criteria: a researcher with established expertise, a strong study design and airtight agreements on handling confidential information. Yet even if collaborating stakeholders can overcome this significant hurdle, they still have several challenges to meet. Collecting, assessing and paying for the massive amounts of RWD presents a substantial challenge. So too does aggregating data from multiple sources and establishing electronic health records standards that render their data useable.

But the value of RWD more than justifies the struggle to meet these challenges, Galen Institute suggests. Unlocking the promise of RWD may improve health care delivery, inform medical decision making, and unleash the full possibility of 21st century medical discovery.


About AfPA

The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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