Project Patient Voice
Project Patient Voice is an online platform that provides patients, caregivers, and healthcare providers with direct access to patient-reported symptom data from cancer clinical trials. Developed by the Oncology Center of Excellence (OCE) Patient Focused Drug Development Program, the platform promotes transparency and supports informed decision-making by amplifying the patient perspective in oncology drug development.
Project Patient Voice provides patients, caregivers, and healthcare professionals with easier access to information about patient-reported outcomes (PROs) collected in cancer clinical trials. Launched in 2020 as an OCE pilot initiative, the project demonstrated how PRO data from cancer clinical trials can be clearly organized and presented. Since then, many approved cancer therapies have incorporated this patient-reported information into their drug labels. For more information about the types of information available on this site, please refer to the section below titled “What is the source of this patient-reported symptom information?”.
A patient-reported outcome is defined as a measurement based on a report that comes directly from the patient (i.e., study participant) about the status of a patient's health condition without interpretation of the patient's response by a clinician or anyone else. A PRO can be measured by self-report or by interview, provided that the interviewer records only the patient's response. Symptoms or other unobservable concepts known only to the patient (e.g., pain severity or nausea) can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others. Source: Patient-Focused Drug Development Glossary.
In simpler terms, PROs are reports collected directly from patients about how they feel and function, without a healthcare provider's interpretation.
Usually, safety information in cancer drug labels is based on healthcare providers' reports of events that occurred during a clinical trial. For example, clinician-reported adverse events are unexpected medical problems that occur during a clinical trial and may or may not be caused by the drug being studied. The cancer product labels listed in Table 2 are notable because they include both clinician and patient-reported outcomes.
PROs come directly from patients and describe how they feel while taking a medication. This may include symptoms they experience, how those symptoms affect their daily life, how tolerable the side effects are, and what they are able to do. Patients typically share this information during clinical trials or through tools such as diaries and surveys. Although PROs reflect each individual's personal experience, they are not always caused by the cancer medication. PROs offer valuable insight to how patients feel during treatment and can help healthcare providers better understand the impact of a treatment from the patient's perspective.
Although PROs are routinely collected in clinical trials, this information is often difficult to find. In some cases, PRO data are included in product labeling, but they are not easily accessible in one place. Project Patient Voice serves as a central hub for available PRO data. By highlighting patients' own experiences, the project supports more informed conversations between patients and healthcare providers about the potential risks and benefits of a treatment.
The information on this website comes from cancer clinical trials that supported FDA approval of cancer drugs. In 2020, the FDA Oncology Center of Excellence piloted PRO data presentation using results from the AURA3 clinical trial (see Table 1 below). The AURA3 data and visualizations were voluntarily provided by the drug company and reviewed by the FDA as part of the drug approval process. Table 2 lists oncology product labels that include patient-reported symptom and function data that also reflects information reviewed by the FDA at the time of the drug approval. The FDA does not endorse any drug, company, or patient-reported outcome measure (such as surveys or questionnaires).
Disclaimer: The information on this website may be updated over time or may link to product labels that may not fully be up to date. For the most current versions of product labels, please visit Drugs@FDA.
Table 1 includes pilot visualizations created in 2020. Click on "AURA3" to view the patient-reported symptoms collected in this clinical trial. Some symptoms were reported based on symptom severity, and others frequency, amount, or occurrence. Each symptom in the table can be selected to open a new webpage displaying bar and pie charts.
For more information on how to read the bar and pie charts in the pilot visualizations, see the interpretation guide.
Table 2 is a list of U.S. oncology product labels that have included patient-reported outcomes since 2020. Some of the PRO information included in these labels are based on the pilot version of Project Patient Voice. Clicking the FDA Label link will direct you to the product label that includes PRO information.
Disclaimer: The FDA labels listed in Table 2 reflect the versions from when PRO information was first included and may not reflect the most current labeling. For the most up-to-date product labels, please visit Drugs@FDA.
Project Patient Voice is intended to be used with a healthcare provider when discussing symptoms related to cancer treatment. It should not be used on its own to make medical decisions or replace professional medical advice. The patient experience data may be limited, as the surveys may not capture every possible symptom.
No, the information included on the website comes from patient-reported outcomes collected during cancer clinical trials that supported FDA approvals. Individual patient experiences cannot be included. If you would like to report an adverse event to the FDA, please visit FDA MedWatch.
Comments and questions can be sent to OCEPPV@fda.hhs.gov.
Table 1: Pilot Patient-Reported Outcomes Data Presentation
Table 2: US Oncology Product Labeling Containing Patient-Reported Outcomes (Since 2020)
Product | Identifier | Date | PRO Measure Used | Label Section | FDA Label |
|---|---|---|---|---|---|
IMDELLTRA (tarlatamab) | BLA 761344 Suppl-001 | 11/19/2025 | EORTC QLQ-C30 | 14.1 | |
BLENREP (belantamab mafodotin-blmf)
| BLA 761440 | 10/23/2025 | PRO-CTCAE; OSDI | 6 | |
ROMVIMZA (vimseltinib) | NDA 219304 | 2/14/2025 | BPI; PROMIS-PF | 14 | |
ITOVEBI (inavolisib) | NDA 219249 | 10/10/2024 | PRO-CTCAE; MBI | 6 | |
RETEVMO (selpercatinib) | NDA 213246 Suppl-011 | 9/27/2024 | FACT GP5 | 14.2 | |
TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs) | BLA 761347 | 9/12/2024 | PPQ | 14.6 | |
NIKTIMVO (axatilimab-csfr) | BLA 761411 | 8/14/2024 | Lee Symptom Scale
| 14 | |
OGSIVEO (nirogacestat) | NDA 217677 | 11/27/2023 | BPI-SF | 14.1 | |
IMBRUVICA (ibrutinib) | NDA 217003 | 8/24/2022 | Lee Symptom Scale | 14.5 | |
NUBEQA (darolutamide) | NDA 212099 Suppl-002 | 8/5/2022 | BPI-SF | 14 | |
REZUROCK (belumosudil) | NDA 214783 | 7/16/2021 | Lee Symptom Scale | 14.1 | |
| JAKAFI (ruxolitinib phosphate) | NDA 202192 | 9/22/2021 | cGVHD Total Symptom Score | 14.4 | Link |
| PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) | BLA 761170 | 6/29/2020 | PPQ | 14.3 | Link |
BPI-SF: Brief Pain Inventory - Short Form
cGVHD: Chronic Graft-Versus-Host Disease
EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30
FACT GP5: Functional Assessment of Cancer Therapy item GP5
MBI: Modified Bother Item
OSDI: Ocular Surface Disease Index
PPQ: Patient Preference Questionnaire
PRO-CTCAE: Patient-Reported Outcomes Common Terminology Criteria for Adverse Events
PROMIS-PF: Patient-reported Outcomes Measurement Information System-Physical Function