Vishal Bhatnagar, MD, on FDA’s New Project Patient Voice

June 30, 2020
Hannah Slater

The associate director for Patient Outcomes in the Oncology Center of Excellence at the FDA spoke about the new pilot program and how it could aid patients and providers moving forward.

The FDA recently launched Project Patient Voice – a website intended to create a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments.

Though this patient-reported data is assessed by the FDA during the drug approval process, it has not historically been included in product labeling, and is therefore largely unavailable to the public.

In an interview with CancerNetwork®, Vishal Bhatnagar, MD, associate director for Patient Outcomes in the Oncology Center of Excellence at the FDA, discussed this new pilot program and how it could benefit patients with cancer.

“So basically, this is data from patients for patients and we find this to be a resource that could be helpful for patients and providers to have a conversation around certain symptoms or side effects that they’re concerned about,” said Bhatnagar.

In the first phase of the Project Patient Voice pilot website, only 1 trial will be included while the FDA collects public feedback on how the information is being presented. The FDA will then use this feedback to consider necessary improvements to the website in order to make the information as user-friendly as possible.

Importantly, Bhatnagar made it clear that this website should not be used as a replacement for clinician-reported safety information, which is already available as part of a drug’s labeling, or as a substitute for guidance from a healthcare professional. Instead, the website is supposed to serve as a complement to this already available information.

“Of course, the product labeling is the repository for the important information that should be considered by patients and providers,” Bhatnagar explained. “What we put on this website is a complementary source of information.”

This segment comes from the CancerNetwork® portion of the MJH Life Sciences National Broadcast, airing daily on all MJH Life Sciences channels.