In the past, the work of the Food and Drug Administration was often bogged down by bureaucratic processes and the red tape of a regulatory environment. The drug approval department could be inefficient, and it didn’t always put patients at the center of the process.

In a new era for the FDA, the focus is on patients. Patients and patient advocacy groups are getting more involved, and KidneyCAN is leading the way.

Today, on February 5th, Bryan Lewis, president of KidneyCAN, visited the FDA for a stakeholders’ meeting called “Envisioning Oncology Product Development for 2025” at the Oncology Center of Excellence (OCE). The mission of the Oncology Center of Excellence is to “achieve patient-centered regulatory decision-making through innovation and collaboration.” The purpose of this meeting was to update the stakeholders on new happenings at the OCE.

Food and Drug Administration

We learned about a number of remarkable initiatives at the OCE, including the following projects:

  • Project Socrates aims to provide insight into the FDA’s role in oncology drug development and the multidisciplinary and team-based approach the FDA takes in this process.
  • Project Facilitate is a single point of contact where FDA oncology staff will help physicians and their healthcare team through the process to submit an Expanded Access request for an individual patient with cancer.
  • Project Renewal is a public health initiative that aims to update the labeling information for oncology products by evaluating relevant scientific evidence from published literature.
  • Project Orbis provides a framework for concurrent submission and review of oncology products among international partners.

Project Orbis supports the global collaboration of cancer research endeavors.

One initiative that really caught our attention is called Project Patient Voice.

OCE Project Patient Voice: Project Patient Voice is an initiative by the OCE that records patient reports of adverse effects during clinical trials for cancer.

This is a pilot website describing patient-reported adverse event data from trials.

We’re so grateful to see patient input included in the process of oncology research. KidneyCAN will continue advocating for the kidney cancer community at events such as these.

 

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