Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice
With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.
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Roche used its Flatiron Health oncology EHR database to generate an external control arm for pivotal single-arm data supporting the personalized medicine candidate, which has an 18 August user fee goal.
Fresenius Kabi’s Omegaven is most recent of 13 approvals, including three with breakthrough therapy designations, where FDA has relied on real world evidence to make a regulatory decision about efficacy.
Buying Flatiron Health offers research-quality electronic medical records data which will help gain access to patients and help in the drug development and reimbursement process, Roche exes say.