Officials from the US Food and Drug Administration’s (FDA) oncology offices say they plan to develop a glossary of patient-friendly terms and definitions for oncology clinical trial endpoints.
In a paper published earlier this month in The Oncologist
, officials from FDA’s Oncology Center of Excellence and Office of Hematology and Oncology Products make the case for working with patients and patient advocacy groups to develop resources to help patients understand the complex and nuanced terminology they are often faced with when making treatment decisions.
“Patients are often left wondering where to start and where to go for understandable information, because medical terminology, specifically terminology surrounding cancer diagnosis and treatment, can be complex,” the officials write.
While common oncology clinical trial endpoints, such as progression-free survival, overall response rate and overall survival, measure different outcomes, patients may have difficulty parsing their differences.
“These terms are ubiquitous in cancer drug development but are nuanced and can be associated with complicated clinical trial designs,” the officials write, noting that a limited understanding of such terms can hinder a patient’s decision-making.
The first step to addressing that gap in understanding, the officials write, is to work with patients and patient advocacy groups to better understand where the confusion lies.
From there, “definitions of common terms can be generated in an iterative dialogue between patients, health care providers, and drug development scientists,” the officials write.
The officials also note that FDA has already begun work in this regard with its “Partners in Progress
” annual workshops which are meant to introduce FDA’s role in oncology product development to patients and patient advocates.
“In collaboration with providers, patients, pharmaceutical industry, caregivers and patient advocates, we intend to further this work with a goal to develop a glossary of ‘patient-friendly’ clinical trial endpoint terms and definitions for patients and providers to use,” the officials write.
They also offered an example of a potential patient-friendly definition of progression-free survival, “the median length of time after the start of this treatment that patients are alive while their cancer does not grow or spread,” but note that more discussion is necessary to ensure that the definitions are understandable to patients.
Going forward, the officials suggest that the glossary could be expanded to cover other terms used in oncology clinical trials, including quality of life, side effect profiles and measures of symptoms.