Blog

The U.S. Food and Drug Administration (FDA) recently launched a new initiative aimed to help patients in the fight against cancer. This project, appropriately named Project Patient Voice, was initiated by the FDA’s Oncology Center of Excellence to give patients and health care professionals unique information that has not been publicly accessible in the past. This unique data will help patients and health care professionals make better-informed decisions regarding treatment options. 

What is Project Patient Voice?

Project Patient Voice is an online platform that provides patients and caregivers access to a collection of patient-reported outcomes from various cancer clinical trials. The outcomes are collected using questionnaires from patients who are currently participating in a clinical trial. The questionnaire collects data about their disease- or treatment-related symptoms, including how severe and how often symptoms and side effects occur.

This project aims to consistently show patient-reported symptom data from select cancer clinical trials. While potential risks and side effects are always disclosed in clinical trials and when using a medication, this data provides extra information to help patients and their care team make informed decisions. For example, information on a drug label is derived from the doctor’s report of adverse events that occurred during the clinical trial. The information shared on Project Patient Voice, however, includes the same data as well as symptoms reported directly by trial participants. 

It is important to remember that while Project Patient Data is a great tool for helping patients and their care teams make informed decisions, it should not be used as the sole tool. It remains important to discuss treatment options with a care team before making any decisions. 

How can I use Project Patient Voice?

Project Patient Voice is currently in the pilot phase. In this pilot, the FDA has limited the data to one drug trial. The reason for this is to allow for feedback from the public regarding usability. After receiving feedback and fine-tuning the system, the FDA aims to expand Project Patient Voice to include more clinical trials. 

The current trial included in Project Patient Voice is AURA3 which is a randomized control trial of the drug TAGRISSO. TAGRISSO is designed to treat advanced non-small cell lung cancers with the EGFR mutation. The project data is available for TAGRISSO on the FDA website and any member of the public is welcome to view it. As more drug trials are added to Project Patient Voice, they will appear on the same table. 

When viewing the table of drugs on the FDA website, users can click on the trial name to view a table of the patient-reported symptoms collected during the trial. Some symptoms were reported based upon severity while others were reported based on frequency, amount, or occurrence. Each symptom can be clicked on and will open a new webpage showing bar graphs and pie charts further illustrating the symptoms. 

Can I add my own experience to the data?

The information included in Project Patient Data is limited to patient-reported outcomes and collected in a clinical trial setting. Data cannot be added by people outside of this setting. However, general feedback and questions about Project Patient Data can be sent via email to Erica.Horodniceanu@fda.hhs.gov. 

Additional Reads You May Enjoy:

Clinical Trials 101 with Clinical Trial Facilitator Cynthia Kerr

Employment Rights for Cancer Patients, Survivors, and Caregivers

New Study Suggests Strong Social Support Can Improve Cancer Outcomes

Stay connected with us! Receive our monthly e-newsletter and blogs featuring stories of inspiration, support resources, cancer prevention tips and more. Sign up here.