Following decades of near total reliance on randomized clinical trial data, the U.S. Food & Drug Administration (with a helpful nudge from the Congress) is accessing private sector technology-based tools as a means of incorporating real world data (RWD) and evidence (RWE) into its drug approval, label expansion and regulatory oversight tasks.
The agency has signaled its apparent change of heart with speeches, policy guidance, and now with two public-private partnerships: the recent expansion of its agreement with Flatiron Health, and a brand new collaboration with COTA Healthcare. The Flatiron collaboration initially focused on patients being treated with immunotherapy for advanced non-small cell lung cancer; the new work concerns “the use of RWE in regulatory decision-making, including characterization of data quality, validation of reliable real-world clinical endpoints, collaboration on new analytic methodologies, and exploration of innovative applications such as real-world control arms.” The COTA collaboration will focus on breast cancer patients and treatment options.
