Project Patient Voice -? Revolution in Consumer Reporting!
Updated: Aug 11
At a time when the world is transitioning from the mandatory HCP (healthcare professional) reporting, we have a fantastic pilot initiative from the FDA, for empowering consumer/patient reporting.
Project Patient Voice is an online platform for patients and caregivers, along with their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials.
Salient Features of this Project
1. Only for Cancer Clinical Trials
2. Web-based reporting of data (public source)
3. Voluntarily shared by the Sponsor and is reviewed by the FDA at the time of approval
4. This patient-reported symptom data is generally not available in the USPI (label in the US)
5. This information could help patients and healthcare providers while discussing the risks and benefits of a drug.
6. No implied Causality with reported symptoms
7. The survey may have collected not all symptoms.
8. Pilot Phase: FDA will provide on their website information on patient-reported symptoms collected during the first six months of treatment in cancer clinical trials.
Scoring for Symptoms that were Reported by Patients While on Treatment:
Source: Sample Data; https://www.fda.gov/about-fda/project-patient-voice/aura3
Although there is some limitation with regards to the information collected, we need to remember this is only a pilot project. One can expect some refinements in future, that will make this more practical, and useful information. We believe this will ultimately pave the way for a revolution in consumer reporting and real-world data!