This article provides an overview of the impact of the new FDA industry guidance on current Patient Reported Outcome (PRO) services and identifies ways that the industry can utilise the emerging PRO toolset to ensure regulatory compliance going forward.
The FDA Final Guidance highlights that in order to produce the most reliable and adequate information sponsors and CROs must re-examine their current PRO methods to ensure that the claims made at submission are consistent with the documented capabilities of the PRO tool. The article details how the incorporation of various combinations of emerging PRO technologies into clinical trials can produce the most accurate picture of the effects of a specific drug on a patient and provide the FDA with clinically valid data that will enable the process of reviewing PRO measures to be accelerated. By conducting clinical trials in accordance with the advice stated in the FDA Guidance, the process of collating PROs will be greatly assisted, enabling sponsors and CROs to overcome a wide range of regulatory challenges and present data that can effectively support medical product claims.
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