---

---

Twitter :

#ConversationsOnCancer

#BlackFamCan

#OCEProjectCommunity

Sponsored by the U.S. Food & Drug Administration (FDA)

Featured Speakers:

Ethan Basch, MD, MSc, Distinguished Professor and Chief of Oncology, University of North Carolina | Physician-in-Chief North Carolina Cancer Hospital | Director, UNC Cancer Outcomes Research Program

Vishal Bhatnagar, MD, Associate Director for Patient Outcomes | Oncology Center of Excellence, FDA

Jill Feldman, Patient Advocate | Lung Cancer Patient

Lee Jones, Patient Advocate | Colon Cancer Patient

Erica Horodniceanu, MPH, Health Scientist, Patient Focused Drug Development Team | Oncology Center of Excellence, FDA

Richard Pazdur, MD, Director, Oncology Center of Excellence, FDA

Mirat Shah, MD, Medical Oncologist and Clinical Reviewer | Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA

Moderator: Rea Blakey, Associate Director for External Outreach and Engagement, Oncology Center of Excellence, FDA

Registration required to attend: https://www.surveymonkey.com/r/03102022

Background:

The FDA Oncology Center of Excellence (OCE) Conversations on Cancer public panel discussion series event on March 10, 2022 will address understanding tolerability in the context of current cancer treatments.

The definition of tolerability has changed over time to include the patient voice. In 2018, a Friends of Cancer Research White Paper communicated a broader working definition of tolerability in cancer clinical trials to incorporate the patient’s perspective and experience: “the degree to which symptomatic and non-symptomatic adverse events associated with the product’s administration affect the ability or desire of the patient to adhere to the dose or intensity of therapy. A complete understanding of tolerability should include direct measurement from the patient on how they are feeling and functioning while on treatment.”

Gaining an accurate understanding of cancer treatment tolerability requires consideration of what, when, and how tolerability is measured. This panel discussion will feature a diverse group of speakers, including patients, clinicians, researchers, and FDA representatives to share their unique perspectives on the complex topic of tolerability. The speakers will discuss the importance and integration of the patient experience in evaluating tolerability (for example, through use of patient-reported outcome measures), clinician consideration of patient-reported tolerability, the impact of tolerability on treatment decisions, and dose optimization.

Webcast Information:

A free-of-charge webcast of this public panel discussion will be provided. Registration for the webcast is required at the link above.

FDA plans to post archived webcasts after the meeting, however, in cases where the transmission was not successful, archived webcasts will not be available.

Contact:

For any inquiries regarding this program, please send an email to: [email protected]