When Will Real World Evidence Be Persuasive? FDA's Temple Offers Perspective
Postmarketing studies randomized to look at real world data sets could provide the key, Temple suggests; Amgen rep describes use of real world data to support approval of leukemia drug Blincyto.
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Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
Breakthrough-designated oncologics used historical comparator data to determine efficacy threshold for pivotal Phase II studies supporting accelerated approval; Blincyto’s subsequent full approval offers validation with conventional controlled study.
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.