News
The FDA's guidance on PROs - raising the stakes or improving the odds?
February 2011
Jane Speight and Shalleen Barendse write in this month’s Applied Clinical Trials on the role of the FDA’s guidance on patient-reported outcomes (PROs) in improving industry and academic standards, ensuring that outcomes reported from the patient perspective are robust and meaningful. Following release of the FDA’s draft guidance in 2006, definitive guidance was eagerly awaited but took almost four years to materialise due largely to the numerous comments and responses received from key stakeholders (more than 50 responses are recorded on the FDA’s website). The FDA’s Guidance for Industry on the use of
patient-reported outcomes in medical product development to support labelling claims (Dec 2009) is a detailed document which clarifies the standards that the FDA expects when PRO measures are used to support medicinal product labelling claims. We argue that while the FDA’s latest document may appear to raise the stakes for industry sponsors, the clarity now provided is likely to improve the odds of successful label claims in the future.
For a copy of the paper, please visit Applied Clinical Trials or contact us.
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