Xerostomia, or dry mouth, is one of the most common symptoms people experience after radiation treatment for head and neck cancer. Xerostomia can be debilitating, and it can severely limit one’s ability to eat and speak, presenting enormous obstacles for daily life and wellness. While there are currently some products on the market to help people suffering from Xerostomia, the options are limited and insufficient, and symptoms often persist.
Inspired by this unmet need, the THANC Foundation partnered with three patient advocacy organizations—the Head and Neck Cancer Alliance (HNCA), the National Foundation for Swallowing Disorders (NFOSD), and Support for People with Oral and Head and Neck Cancer (SPOHNC)—to gain valuable insight from people enduring xerostomia and to develop goals for future treatments predicated on the patient experience.
On August 19, 2021, our collective organizations will host a virtual Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting. We will base this meeting on the format and goals of an FDA-led Patient-Focused Drug Development (FDA-led PFDD) meeting. The FDA developed PFDD meetings in 2012, seeking patient perspectives on specific diseases and treatments in a systematic and intentional manner. To expand the benefits of their initiative, the FDA now welcomes external patient organizations to identify unmet patient needs and lead their own meetings, using the process established by FDA-led meetings as a model.
We hope to bring together diverse community members who are impacted by xerostomia and provide the platform needed for dynamic conversation and collaboration. Patients will have the chance to share their experiences and respond to the stories and thoughts of others. Through both live attendees and predetermined patient participants, we will foster active engagement and provide ample opportunity for people’s voices to be heard.
The PFDD meeting allows for the full patient population to achieve representation and for first-hand patient experiences to inform drug development. Key stakeholders, including patient advocates, researchers, drug developers, and healthcare providers, among others, are invited to listen to the voice of the patient.
We hope through our collective effort, and by creating the space for patients to offer their knowledge and advice, we will gather valuable data and gain meaningful insight. Ultimately, by encouraging patients with xerostomia to help shape the development of treatments, we hope to better alleviate their suffering and substantially improve their lives.