Flatiron Health announced a collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to explore how real-world evidence derived from de-identified patient data captured at the point of care can be used for clinical trial design and prospective research studies.
The NCI’s Cancer Therapy Evaluation Program (CTEP), which coordinates the cancer therapeutics development program of the NCI’s Division of Cancer Treatment and Diagnosis, will be leading the partnership with Flatiron. NCI funds an extensive national program of cancer research and sponsors clinical trials to evaluate new anti-cancer agents.
The collaboration will begin by first exploring how real-world evidence derived from Flatiron’s melanoma and non-small cell lung cancer datasets can be used to improve study planning, inform sample size calculations, ease study implementation, better understand current trends in standard of care and address specific study planning questions.
The 21st Century Cures Act, enacted by U.S. Congress in December 2016, makes modernizing clinical trial designs and use of real-world evidence a legislative priority within the United States’ most experienced and sophisticated research networks. The collaboration between Flatiron and NCI aligns with those priorities, and builds towards a key goal in cancer research: understanding how data and technology can accelerate meaningful evidence generation. It also aligns with the NIH and U.S. Food and Drug Administration’s work in exploring pragmatic clinical trials to generate broadly-applicable prospective real-world evidence.
“Real-world evidence can add significant value to improving patients’ lives. The secondary use of the real-world data allows for the analysis of new patterns of care and the determinants of health, the evaluation of the effect of specific interventions, drug safety surveillance and population-level genetic studies,” said Elad Sharon, M.D., M.P.H., senior investigator at NCI CTEP. “Our relationship with Flatiron is an example of how we can leverage meaningful partnerships to maximize the outcomes of the research NCI funds in this important field.”
“We are looking forward to applying our learnings in real-world data to work with NCI in exploring how real-world evidence can be used even earlier in the drug R&D process,” said Amy Abernethy, M.D., Ph.D., chief medical officer and chief scientific officer, Flatiron Health. “We are fortunate to be able to work with CTEP and NCI, the lead governmental cancer research organization in the United States, to undertake this transformational work.”