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FDA Workshop Opportunity- Make your voice count!


KatieB

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Hello HOPEtastic LCSCers!

Here is an opportunity with the FDA for those who are interested in research advocacy. Please reach out to the contact listed if you have any questions!

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OUTREACH EMAIL/LANGUAGE TO PATIENTS TO PARTICIPATE In the Workshop

Research advocacy opportunity with the FDA

Make your voice count by having a seat at the table!

The U.S. Food and Drug Administration (FDA,) Center for Devices and Radiological Health (CDRH), is planning a Virtual Public Workshop in April 2022. The purpose of the workshop is for stakeholders, including patients, to share information that will help FDA develop approaches to ensure the safety and effectiveness of a new device-based therapy for cancer patients with Oligometastatic Disease of the Lung (OLD).

Cancer cells from the original (primary) tumor can travel through the body and form a small number of new metastatic tumors in one or two other parts of the body. For example, cancer cells may spread to form one or two new tumors in the brain or in the liver. This is called Oligometastatic Disease. The new therapy involves inserting a probe into the tumor, through a fiberoptic scope placed down into the airways of the lung to access and directly treat tumors that may metastasize from primary tumors (e.g., lung, kidney, colon, or rectum) specifically to the lung (OLD).

During this workshop, patients like you, will have an opportunity to share their perspectives about this new therapy that is designed for cancer patients who have had a good response to treatment of their tumor at the original site; for example, in the lung, kidney, colon or rectum, but have developed a few new small tumors at other sites in their lungs.

You (patient or caregiver) are eligible to participate in the workshop if:

1. You/The patient were/was diagnosed with oligometastatic cancer in the lung and are currently receiving treatment for the cancer

2. The primary cancer is under control (meaning it is stable or shrinking)

3. You/The patient have/has been diagnosed with OLD by your treating oncologist

4. You/They have received treatment in the past for the OLD

We are asking you as a cancer patient with OLD (or patient caregiver), to participate in a panel discussion with other patients and healthcare experts sharing:

• your OLD medical condition and medical device treatment experience during an approximately 1-hour virtual panel discussion, including how you were diagnosed, treated and are currently being managed,

• how OLD has impacted you physically and emotionally, throughout the course of your illness, and the physical and emotional consequence(s),

• how managing OLD symptoms has impacted your quality of life, family members or loved ones,

• information that will help FDA develop approaches to ensure the safety and effectiveness of this new treatment.

We are also asking to pre-record your presentation early next year, so that we may share your video during the meeting. We have staff who will work with you to make the recording process easy.

By participating in this public workshop, you will have an opportunity to bring your valuable perspective about living with OLD and factors that should be considered during the design and conduct of clinical trials for aa new device-based therapy.

If you are available to participate in the workshop, please contact Tracy Gray at tracy.gray@fda.hhs.gov

Thank you.

Tracy

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