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Bill Frist and Bart Gordon: Develop Drugs With Data

U.S. News & World Report

Monday, July 11, 2016

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With continuing advances in science and technology, the pace of medical breakthroughs is accelerating. Today, we can treat or even cure conditions that significantly shortened life just a generation ago. The exciting promises of personalized medicine are now becoming reality.

But bringing new drug discoveries to patients remains a slow process. On average, it takes 10 years and $2 billion to bring a new medication to market. With 10,000 known molecular-based diseases, and approved treatments for only 500 of them, the urgency of finding the next generation of cures is clear.

Real-world data – data already amassed in electronic health records and other clinical software, claims systems and even in patients’ personal health tracking devices – is a rich source of information that can play a key role in accelerating the Food and Drug Administration’s approval process for promising drugs and devices to patients in need. While the use of real-world data in pre-market evidence development is not specifically prohibited by law, the lack of clarity regarding its use to support drug approvals has hindered its incorporation.

As co-chairs of the Bipartisan Policy Center’s initiative on Advancing Medical Innovation, we have been working with experts and stakeholders to explore a range of ways to improve the discovery, development and delivery of cures for Americans. Last year, the center released recommendations in a number of key areas that we felt were ready for bipartisan action. One of those recommendations was to expand the generation and use of real-world evidence to enhance research and shorten the pathway to drug approval, while maintaining the highest standards of safety.