The Development of the Oncology Center of Excellence Patient-Friendly Language Glossary of Oncology Clinical Trial Terms

Abstract

Abstract Oncology clinical trials terms and definitions have become increasingly complex, which has led to shortcomings among research staff and healthcare providers in informing clinical trial participants with the study results and consenting procedures in simple language. Understanding oncology clinical trial terms is of critical importance to assist patients and caregivers in making cancer treatment decisions, including enrollment into clinical trials. The U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) organized a physician and patient advocate-led focus group, with the primary goal of publishing a patient-centric public glossary of select cancer clinical trial terms for healthcare providers, patients, and caregivers. This commentary reports the results of the focus group sessions that gave FDA OCE valuable insights into how patients perceive clinical trial terms and how oncology clinical trial definitions can be improved to effectively communicate information to the patients to make better informed decisions about their treatment options.