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!

Reference: https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice