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                Oncology Center of Excellence

Oncology Center of Excellence

                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


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          Project Patient VoiceOncology Center of Excellence Project Patient Voice
  
  	
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              Project VoiceProject 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.

What is the purpose of Project Patient Voice?
	The aim is to show patient-reported symptom data consistently from select cancer clinical trials of approved products. This data is usually not in the US Prescribing Information (drug label) but can give healthcare providers extra information to discuss with patients and caregivers. If you are a patient or caregiver, and have questions about what you see here, ask your healthcare professional for more information.    
Why is this needed?
	The FDA receives patient experience data, which is collected in clinical trials using surveys and completed by trial participants. Many groups, including FDA, would like patient experience data to be available to the public, but the drug label that describes the trial(s) lacks the flexibility (space, color) that an online solution can provide. Patient-reported symptom data is important information that could help patients and healthcare providers when talking about the risks and benefits of a drug.    
What is the source of this patient-reported symptom information?
	The data on this website came from cancer clinical trials supporting FDA approval of a specific cancer drug. This information was voluntarily provided by the company making the cancer drug and was reviewed by the FDA at the time of drug approval. The FDA does not endorse any drug, company, or specific patient-reported outcome measure (survey or questionnaire).    
What is the difference between patient-reported symptom information and the safety information in the drug label?
	Information in the drug label is from the doctors’ reports of adverse events that occurred during the clinical trial. Adverse events are unexpected medical problems that occur during a trial. The drug under study may or may not have caused these adverse events. The information on Project Patient Voice is from the same trial but includes symptomatic adverse event data (symptoms) that was reported directly by trial participants. Again, the drug under study may or may not have caused these adverse events. Questions about symptoms were asked to participants. These symptoms were chosen by the drug company to cover known side effects of the drugs under study.    
What is the Pilot Phase of Project Patient Voice?
	In this pilot, FDA will provide on their website information on patient-reported symptoms collected during the first six months of treatment in cancer clinical trials. The pilot is currently limited to one drug trial. The purpose of this pilot is to get feedback from the public on the usability of the website. The FDA hopes to expand this to include more cancer drug trials.    
How to use Project Patient Voice
	The table at the bottom of this webpage shows a row for each drug profile. Each trial name within the table can be clicked on to view a table of the patient-reported symptoms collected during the trial. Some symptoms were reported based on symptom severity, and others frequency, amount, or occurrence. Each symptom in the table can be clicked on to open a new webpage showing bar and pie charts.

The bar charts show the percent of patients reporting how often they had the symptom over six months. In many trials, less than half of the trial participants are still taking the drug at six months. The main reasons that trial participants stop taking the drug include progressive (worsening) disease, death, and drug toxicity. As these charts capture only the first six months on treatment, they do not reflect patient reports of symptoms that appear after the first 6 months of treatment and may not show the pattern of worsening/improving that may occur with certain symptoms as treatment continues (e.g., nausea, neuropathy). The bar charts include the number of trial participants who were still taking the drug at each week. Each bar represents a week and the colors correspond to the responses trial participants gave. On the outside of the bar graph under “N” are the number of participants who gave a response that week. The percentage in the green space is the group of patients who did not have the symptom that week.

The pie charts show the worst response a participant gave during the first 24 weeks of taking the drug. For example, at week 4, a participant might have reported “frequent” nausea, but after week 4 their nausea was occurring “occasionally” (representing an improvement). In the pie chart, this participant would be counted in the area of the pie chart representing “frequently”, because that was their worst nausea score.

For more information on how to read the bar and pie charts in Project Patient Voice, click here.    
Limitations of Project Patient Voice
	Project Patient Voice is intended to be used with a healthcare provider when talking about symptoms related to a cancer and cancer treatment. You should not rely on Project Patient Voice alone to make decisions about medical care. You should not use Project Patient Voice to substitute for advice from your healthcare provider. Conclusions about patient symptom experiences may be limited, because not all symptoms may have been collected by the survey.    
Can my experience with symptoms be added to this information?
	No, the information included on the website is limited to patient-reported outcomes collected in a clinical trial setting. If you have an adverse event that you would like to report to the FDA, you should use the FDA MedWatch website.    
Where can I send comments or questions about Project Patient Voice?
	Comments and questions can be sent to: Erica.Horodniceanu@fda.hhs.gov

Trial Name
			Disease Type
			Drug
			Study Design
			Blinding Status
			Comparator Arm
			Patient Questionnaire Used to Collect Symptom Data
			FDA Label**AURA3**
			Advanced non-small cell lung cancer with EGFR mutation
			TAGRISSO
			Randomized
			Open label
			Platinum-based doublet chemotherapy
			PRO-CTCAE
			Here

                                                                                  Content current as of:
      03/17/2023Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


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