FDA launches pioneering pilot to make public patient reported outcomes of clinical trials

This week (23 June, 2020) the US Food and Drug Administration (FDA) launched a pioneering pilot project Patient Voice. It is an open source web portal that will for the first time make publicly accessible the information about patient-reported symptoms during cancer clinical trials.

The project was initiated by the Oncology Center of Excellence to give patients and health professionals access to symptomatic side effects experienced by clinical trial participants. Its aim is to allow patients and their physicians to be better informed about treatment choices.

The Project Patient Voice website will include a list of cancer clinical trials that have available patient-reported symptom data. AstraZeneca is the first company to provide patient-reported outcome data for one of their FDA-approved drugs and has collaborated with the FDA to identify methods to display the information in a way that is informative to health care professionals and patients.

Read more at about this patient-centred pilot at the FDA website.



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