The CO10s are back from ASCO 2019! Last week, Chicago was a hub for the best of the best in cancer care to convene on the topic of Caring for Every Patient, Learning from Every Patient. A major topic of discussion at this year’s conference was the use of RWE by oncologists and regulatory agencies who are interested in new approaches to manage collected patient data.
Acceptance of RWE
The importance of precision medicine in oncology is growing rapidly, and with it, advances in the generation and analysis of real-world data (RWD) and RWE are happening here and now. Clinical trials remain crucial, and the goal should never be to replace them. However, there is increased acceptance that RWE can augment clinical trial findings obtained in carefully controlled populations and settings. With clinical trials only enrolling approximately 5% of the cancer patient population, RWE can provide insight on a much larger and broader scale, to bring enhanced care to patients and further learning from study findings.
Our meetings and conversations at ASCO gave us hope that there is an industry shift happening. There is no doubt that clinical trials are here to stay, but RWE is increasingly being used to accelerate and support clinical research and there is no turning back.
FDA’s Willingness to Collaborate
For more than a decade, the FDA has relied on RWD in post-marketing safety surveillance. More recently, during Scott Gottlieb’s tenure as commissioner, the FDA explored the potential for RWE to accelerate the drug development process. While Dr. Sharpless is just beginning his acting role as commissioner, given his background in cancer research, clinical trials and healthcare innovation, we are confident his support of RWE will be as impactful as Gottlieb’s.
Further reinforcing the desire to understand and apply RWE, last week we signed a two-year Research Collaboration Agreement with the FDA to study variations in cancer treatment patterns using RWD. The partnership will provide the FDA with invaluable information surrounding treatment patterns and patient outcomes in a broader set of patients than is typically available in clinical trial results. This information will enable precision medicine at a larger scale, which subsequently will help drive improved outcomes as well as cost reduction.
The industry is entering a new period of clinical research and discovery with RWD and RWE, as researchers continue to put the patient first. While the next 12 months are certainly promising, challenges still exist, including important steps such as gaining access to important data from EHRs and scrubbing and categorizing them to make sure they are research-grade. However, we are excited to see where our collaboration with the FDA takes us and how far the industry will go with real-world evidence to improve cancer care. We are proud to be on the frontlines as this change takes place, doing our part to bring clarity to cancer care.