FDA: The Voice of the Patient – Childhood Cancer Hearing Loss
Introduction:
On September 13, 2018, four advocacy organizations – Children’s Cause for
Cancer Advocacy, Children’s Brain Tumor Foundation, Mattie Miracle Cancer
Foundation, and Momcology – hosted an Externally-Led Patient-Focused Drug
Development (EL-PFDD) meeting to share with senior officials at the U.S. Food and
Drug Administration and other chemotherapy-induced pediatric hearing loss
stakeholders (e.g. families, caregivers, and individuals with hearing loss, as well as
industry and research institutions) the perspectives of people living with
chemotherapy-induced hearing loss, its impact on their daily lives, and their
expectations and priorities for current and future treatments for the condition.
The meeting was conducted in accordance with the agency’s Externally-Led
Patient-Focused Drug Development initiative to more systemically gather
patients’ perspectives on their conditions, and available therapies and treatments.
In addition, the recently passed 21st Century Cures Act has emphasized the
importance of patient input in the regulatory process, mandating that regulators
learn about which outcome measures matter to patients and to consider how
patients weigh the balance of risks and benefits of a particular treatment
Since 2004, UT Health San Antonio, Greehey Children’s Cancer Research Institute’s (Greehey CCRI) mission has been to advance scientific knowledge relevant to childhood cancer, contribute to understanding its causes, and accelerate the translation of knowledge into novel therapies. Greehey CCRI strives to have a national and global impact on childhood cancer by discovering, developing, and disseminating new scientific knowledge. Our mission consists of three key areas — research, clinical, and education.
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