Washington, D.C. – As Congress moves forward on medical innovation legislation and the administration continues its precision medicine and cancer “moonshot” initiatives, the potential to modernize the drug discovery, development, and delivery process is within reach. That’s in part because of the growing amount of patient information being captured during routine care. While managing patient privacy, this data now offers the opportunity to accelerate the development and delivery of safe and effective treatments and cures.
Today, the Bipartisan Policy Center’s Health Innovation Initiative announced that it will explore new policies to expand the use of such data—also known as real-world evidence. This information could augment and support traditional randomized controlled trials and post-market surveillance efforts, and reduce the time and cost of bringing safe and effective drugs to the market in the United States.
Utilizing data from clinical and patients’ experiences was emphasized in BPC’s 2015 report, Advancing Medical Innovation for a Healthier America. The report recommended a series of policy actions that Congress can take to improve the medical product development process. One of those actions focused on expanding the use of clinical, claims, and patient-generated data to improve the Food and Drug Administration’s (FDA) approval and post-market surveillance processes as well as the development and delivery of drugs and devices. This month, the new FDA Commissioner, Robert Califf, highlighted evidence generation as a top priority of the agency.
Currently, researchers and developers have to spend on average $2 billion to bring a new drug or therapy to market and the regulatory process on average takes more than ten years. Clinical trials are the most critical and expensive phase of the drug development process. However, they are restricted to a select group of patients which limits their ability to create evidence that can be used for a broader patient population. Using real-world data can significantly strengthen the evidence base for approval, safety, and effectiveness.
“The vast increase in the amount of data available from patients and the clinical setting offers an opportunity to change the paradigm for evidence development in the United States,” said Bill Frist, MD, senior fellow and co-chair of the Advancing Medical Innovation effort at BPC. “Leveraging real-world evidence to support medical product development and delivery was one of the key areas of focus within our recently released recommendations on advancing medical innovation.”
“As we move toward more innovative therapies, the value of incorporating patients’ experiences cannot be overstated,” said Ted Giovanis, president of the Jayne Koskinas Ted Giovanis Foundation for Health and Policy, which is helping to support BPC’s advancing medical innovation effort. “The U.S. must develop a policy and data infrastructure to take full advantage of the wealth of patient information that can support the efficacy and safety of new drugs and therapies and inform pre- and post-market decision making.”
“The use of electronic data from both the clinical setting and patients holds great promise for improving the generalizability of research findings to broader populations and bolstering post-market surveillance efforts,” said Janet Marchibroda, director of health innovation at BPC. “We look forward to exploring how new sources of data can be used to augment clinical trials and post-approval processes and the policies needed to advance these efforts.”
Learn more about BPC’s work on medical innovation here.