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

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.

Related Videos
Experts on MM
Experts on multiple myeloma
Experts on MM
Daniel G. Stover, MD, suggests that stromal tumor infiltrating lymphocytes may serve as a biomarker of immune activation and can potentially help optimize therapy with microtubule-targeting agents for patients with metastatic breast cancer.
Experts on multiple myeloma
PRGN-3005 autologous UltraCAR-T cells appear well-tolerated and decreases tumor burden in a population of patients with advanced platinum-resistant ovarian cancer.
Related Content