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Patient-Reported Outcomes: Open-Label Trials Can Be Designed To Minimize Bias, US FDA Says

 
• By Sue Sutter

With the expectation for increasing amounts of patient experience data comes the need for the FDA and sponsors to consider, and account for, the degree to which open-label bias influences oncology trial PROs; agency staff suggest trial design elements and analytic approaches for dealing with bias at a meeting on cancer clinical outcomes assessments.

Patient experience data
Even in an open-label trials, patients should be asked about their experience with a cancer drug. • Source: Shutterstock

Open-label studies may carry a risk of potential bias in patient-reported outcomes. However, this should not preclude PRO data collection in open-label cancer drug studies, and there are designs and analytic approaches to identify and minimize bias in such data, US Food and Drug Administration staff and other experts said at a 29 June meeting.

The agency’s seventh annual clinical outcomes assessment in cancer clinical trials workshop focused on use of PROs in open-label trials....

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