Real World Data and its promise for medicine and research

By Grace-Marie Turner

Better access to data about real world patient experience holds enormous potential to help achieve many of the goals of health reform, including improving the quality and delivery of medical care, reducing costs, and improving safety and outcomes by accelerating the knowledge base upon which the development of new treatments and cures relies.

Capturing data about the actual experience of patients outside of the carefully controlled clinical trial setting – Real World Data – can help fill the knowledge gap between clinical trials and clinical practice.  RWD offers a treasure-trove of information that could allow providers, innovators, health plans, researchers, and others in the scientific and medical communities to make faster, more efficient, and less costly advances in medical research and clinical treatment. Life sciences companies can use this data to explore the benefits and risks of treatment options including their effectiveness in patient subpopulations, expedite enrollment in clinical trials, identify new targets for research and development, and transform the value equation in medical care.

However, there are obstacles that must be removed for the promise and potential of Real World Data to be realized.

While the potential is great, the future of RWD is highly uncertain. Governments and private health care companies who administer government-sponsored health insurance have vast databases of information, primarily medical claims. Most of this information is inaccessible to the researchers who are developing the next generation of treatments and cures, such as pharmaceutical and medical device companies and academics.

Longstanding policies by the Department of Health and Human Services deny access to federal Medicare A, B, D, Medicaid, and other data sets on Prescription Drug Event (PDE) data by entities with commercial interests, yet these are the very entities that we rely on to invest in the expensive process of bringing new treatments to patients.  These policies inhibit medical research and ultimately are detrimental to patients whose care could be improved by access to more robust information. In cases where academics are able to request access to the government data, the cost is often prohibitive.

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