Webcast | Virtual

Event Title

Optimizing the Assessment of Cancer Treatment Tolerability: Examination of Patient-Reported Symptoms & Physical Function

January 21, 2025

Date:: January 21, 2025

Yale University/Mayo Clinic CERSI

Tuesday, January 21, 2025
3:00 – 4:00 PM (Eastern Standard Time)

Presented By

Gita Thanarajasingam, MD
Associate Professor of Medicine,
Consultant in Division of Hematology at Mayo Clinic

About the Presentation

This talk will emphasize the importance of measuring tolerability in cancer clinical trials, highlighting key patient-reported outcomes that are integral to the assessment of treatment tolerability. The presentation will focus on patient-reported symptomatic adverse events (AE) and patient-reported physical function, two domains emphasized in the recent FDA Guidance for Industry on Core-Patient Reported Outcomes in Cancer Clinical Trials. The talk will highlight recent Mayo-Yale CERSI projects in collaboration with FDA subject matter experts, including a prospective multi-modal study of physical function in patients receiving cancer therapy, and an analytic project focused on developing optimal graphics of physical function.

The objectives of the presentation are to:

Review the standard approach to evaluating tolerability in cancer clinical trials, why it fails to capture tolerability, and why this matters to patients with cancer
Introduce newer approaches to toxicity and tolerability assessment that capture the patient perspective
Highlight recent Mayo-Yale CERSI projects in collaboration with FDA subject-matter experts focused on capturing and analyzing patient-reported physical function
Discuss ongoing initiatives focused on improving the understanding of cancer treatment tolerability

About the Presenter

Dr. Gita Thanarajasingam is an Associate Professor of Medicine and consultant in the Division of Hematology at Mayo Clinic in Rochester, Minnesota. She is a graduate of Yale University and Mayo Clinic Alix School of Medicine and completed her residency at the Brigham and Women’s Hospital at Harvard Medical School. After Hematology and Oncology Fellowship and Advanced Lymphoma Fellowship at Mayo Clinic, she joined the faculty of the Mayo Clinic Rochester Lymphoma disease-oriented group. Her clinical practice as an oncologist is focused on Hodgkin and non-Hodgkin lymphoma, and she performs health outcomes research in lymphoma and other cancers.

As a clinical investigator, her work focuses on improving the evaluation of adverse events (AEs) of treatment and measuring their impact on treatment tolerability cancer patients. She developed the Toxicity over Time (ToxT), a longitudinal patient-focused approach to AE evaluation. She is active in the implementation of patient-reported outcomes (PRO) to better understand treatment toxicity and tolerability. She serves of as vice co-chair of the Alliance for Clinical Trials in Oncology Health Outcomes Committee and is the recipient of K and U01 grants from the U.S. National Institutes of Health. She leads the ongoing international multi-stakeholder Lancet Haematology Commission, “Beyond maximum grade: modernizing the assessment and reporting of adverse events in hematological malignancies.” She is an international advisory board member of the Lancet Haematology and an ad-hoc member of the U.S. Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) with expertise in toxicity assessment. Her research program overall endeavors to improve the accuracy and patient-centeredness of AE evaluation and better understand cancer treatment tolerability from the patient’s perspective.

Remote Access Information

Advance Registration Required.

For Questions and Reasonable Accommodations

Please contact Ruize Li at Ruize.Li@fda.hhs.gov or go to Interpreting.Services@oc.fda.gov.