Clinical Trial Methodology for Geriatric Oncology –JCOG Geriatric Research Policy

Abstract

In 2014, JCOG has established the Geriatric Study Committee and it established a policy describing principles or methodologies for geriatric studies. The policy classifies elderly patients into 3 categories: i) fit patients who can undergo a general standard treatment; ii) vulnerable patients who cannot undergo the general standard but can receive some less toxic regimens, and iii) frail patients for whom best supportive care is applied. Unmet needs often exist in vulnerable patients. Variations of study designs for geriatric studies are also described in the policy. An appropriate study design depends on a clinical question. When a clinical question is which treatment is better, a randomized clinical trial is still a gold standard even for elderly patients. Depending on a clinical question, a single-arm “bridging” design, a single-arm “extended” design, or observational study is applicable. The policy also includes study endpoints and some recommended geriatric assessment tools.