The U.S. Food and Drug Administration launched Project Patient Voice, which is designed to provide a web-based source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments, the agency said in a news release. The project is an initiative of the FDA’s Oncology Center of Excellence (OCE.)
“While this patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labeling and, therefore, is largely inaccessible to the public,” the agency said.
The FDA said patient-reported outcome (PRO) data is collected using questionnaires that patients complete during clinical trials. These questionnaires are designed to capture important information about disease- or treatment-related symptoms. This includes how severe or how often a symptom or side effect occurs.
The Project Patient Voice website will include a list of cancer clinical trials that have available patient-reported symptom data. Each trial will include a table of the patient-reported symptoms collected. Each patient-reported symptom can be selected to display a series of bar and pie charts describing the patient-reported symptom at baseline (before treatment starts) and over the first 6 months of treatment. This information provides insights into side effects not currently available in standard FDA safety tables, including existing symptoms before the start of treatment, symptoms over time, and the subset of patients who did not have a particular symptom prior to starting treatment.
In the first phase of the project, only one trial will be included while the FDA seeks public feedback on how the information is presented. The FDA will use this feedback to consider improvements to the website to make the information as user-friendly as possible.
