Prospective Clinico-Genomic Study
Flatiron Health, Foundation Medicine, and Genentech partnered to design a low-burden prospective study for patients with advanced lung cancer, addressing the burden of traditional clinical trial designs requiring cumbersome documentation and manual, multi-system data processes. The study used less restrictive eligibility criteria, centralized workflows through OncoTrials integrated with OncoEMR, and a real-world design that captured data directly from EHRs without a separate electronic data capture (EDC) system. Results: 950 enrollments over 18 months, 0 EDC fields required, 100% of surveyed sites said they would run a similar study again, and one practice enrolled over 40% of its eligible patients.
Flatiron Health is a Roche-owned company supplying EHR-derived oncology real-world data, captured at the source through its own OncoEMR software.
This sits in the Data Providers stage of the AI use-case lifecycle: Named examples from the real-world-data, claims and competitive-intelligence providers pharma AI systems are trained on, benchmarked against, or run inside of.
Published by Flatiron Health on its own site — read the original case study on resources.flatiron.com ↗
Related use cases
- 01Novartis - Taf + Mek external control analysis (BRAF V600E NSCLC), from Flatiron Health's RWE case studies (ResearchX Episode 5)
- 02Amgen - Lumakras/KRAS G12C natural history study, from Flatiron Health's RWE case studies (ResearchX Episode 5)
- 03Takeda - mobocertinib/Exkivity benchmark analysis, from Flatiron Health's RWE case studies (ResearchX Episode 5)
- 04A retrospective electronic health record-derived study supporting the accelerated approval of a new drug for mantle cell lymphoma in the U.S.
- 05Real-world clinical outcomes and comparative effectiveness of a drug in patients with recurrent ovarian cancer in the U.S.
- 06Kadcyla (T-DM1) in HER2+ mBC: Label Update on LVEF following a post approval commitment - based on RWD