The FDA will create a website to host information on patient-reported symptoms from cancer-related clinical trials, making it more easily accessible to the public and healthcare professionals.
Patient-reported outcome data is collected using questionnaires that patients complete during clinical trials, but that data is not readily available to the public. The website created by the FDA initiative, Project Patient Voice, will include a list of cancer clinical trials that have patient-reported symptom data. Each of those trials will include a table of the patient-reported symptoms collected.
The initiative aims to give "patients and healthcare professionals unique information on symptomatic side effects to better inform their treatment choices," said Amy Abernethy, MD, PhD, the FDA's principal deputy commissioner.
The FDA will pilot the website with one trial that has patient-reported data and seek feedback on the presentation of the information. It will then use the feedback to build the website.