Geriatric Research Policy: Japan Clinical Oncology Group (JCOG) policy.

ABSTRACT

Due to the rapid aging of Japan's population, clinical research focusing on older patients with cancer is urgently needed. The Japan Clinical Oncology Group (JCOG) has conducted several such clinical trials, but there has been no formal policy for geriatric research. We have therefore established a JCOG policy for geriatric cancer research. We defined the patient selection policy based on treatment tolerance and chronological age. Older patients are categorized into three conceptual groups 'fit patients' who can undergo the same standard treatment given to younger patients, 'frail patients' for whom best supportive or palliative care is indicated and 'vulnerable patients' who fall between the fit and frail categories. Unmet needs often exist for vulnerable patients. The policy recommends that study endpoints include not only survival but also other endpoints such as physical and cognitive function because the objective of therapy in older patients is not only extended life expectancy but also maintenance of the patient's general condition. In this viewpoint, co-primary or composite endpoints that incorporate geriatric assessment in the study design are often applicable. Study design will differ depending on the study population, clinical question, and treatment. Even for older patients, a randomized clinical trial is still the gold standard when the clinical question asks which treatment is better. An observational study of a broader population is applicable for investigating actual conditions of older patients. This JCOG Geriatric Research Policy includes several practical solutions for various issues in geriatric research. We plan to revise this policy periodically to guide future geriatric research.