Want Better Clinical Trial Design? Get Early Patient Input, Says FDA
A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.
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A new guidance document from the US agency offers advice on how sponsors can use patient advocates to improve and streamline device clinical trials.
Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.
The Prometheus Group reportedly told health care providers that they could reuse probes that were part of its pelvic floor therapy system on multiple patients by covering them with a condom or the finger of a rubber glove.