The US FDA Launches Project Patient Voice to Share Patient-Reported Outcomes from Cancer Trials

Shots:

• The US FDA has launched the new pilot program to share patient-reported symptoms during clinical cancer drug trials. Project Patient Voice is an initiative from the FDA’s Oncology Center for Excellence, featuring a public website, making the data available from patients taking part in cancer trials
• The companies conducting clinical trials will voluntarily share patient-reported symptoms. The website will include a list of cancer clinical trials along with PRO data. Each patient-reported symptom can be selected, exhibiting a series of bar/ pie charts describing the patient-reported symptom at baseline and over the first 6 mos. of treatment
• The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development. AstraZeneca is the first company to PRO data for their approved therapy and has collaborated with the FDA to identify methods to display the information to HCPs and patients

Click here to read full press release/ article | Ref: FDA | Image: FDA