FDA Commissioner https://www.fda.gov Scott Gottlieb MD., keynote speaker at the National Comprehensive Cancer Network’s (NCCN) https://www.nccn.org “Oncology Policy Summit” at the National Press Club on June 25, 2018, discussed FDA’s approaches to providing real world data to support changes in the 21st century.
The speed of advances particularly in immunotherapies used across a wide range of tumor types along with combination treatment approaches each with a different profile of adverse events, has created a need for reliable databases for optimizing patient outcomes and minimizing safety risks.
He pointed out how FDA is using analytics to support new approaches throughout the full life-cycle of FDA approved products. New sources of real world evidence are helping us to understand the efficacy of new products in the real world clinical setting so that patients are able to make more informed treatment decisions.
FDA in addition to accessing more detailed clinical data, is also developing and applying modern computational techniques such as natural language processing, artificial intelligence, and machine learning to more effectively and efficiently obtain real-time trends in the safety and effectiveness of marketed medical products.
Dr. Gottlieb explained how FDA is collaborating with the National Cancer Institute https://www.cancer.gov to develop digital biomarkers for measuring cancer pain, quality of life, functional status, and cognitive function by using biometric sensors, computer vision, and voice recognition technologies.
He added, “For FDA to work effectively with data, digital, and technology needs, data tools need to be available to fully support the kinds of clinical trial approaches that the agency is involved in. This requires building out more capacity to use real world data, especially in the post market setting to evaluate the long term safety and benefits for new treatments.”
There are several ways that industry can help FDA. The agency seeks help from industry especially the payers, who sit on mountains of data that can produce real world evidence as the result of the agency’s post market work. FDA hopes that payers will consider doing more to share this data through public-private partnerships.
FDA especially has interest in seeing payers share more post market data on long term oncology patient outcomes and especially on any adverse effects associated with targeted drugs, including checkpoint inhibitors.
In addition, more public private collaborations are needed to share outcomes data from EHRs and other real world sources such as claims data for tracking adverse events to advance the standard of care. Having this information, could allow payers to better relate prices to value, reduce hospitalizations and physician visits, plus impact healthcare costs.