Enrollment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US Food and Drug Administration.

By L. Talarico, Gang Chen, R. Pazdur. Journal of Clinical Oncology, 2004

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Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. (2011, background): “tients are somewhat different of patients of the ‘‘real life’’ [14], it is worth noting that MACH-NC patients are mostly male in their sixth or seventh decade, suffering from locally advanced cancers.”
Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. (2011, background): “Oncologists are ill prepared for this demographic shift, because older adults have been underrepresented in oncology clinical trials that set the standard of care.(2,3) The available data suggest that older adults derive benefit from chemotherapy similar to that derived by younger adults,(4,5) older”
Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis (2014, background): “Older patients—especially frail patients, those with organ dysfunction, or those with poor health status—are often excluded from cancer clinical trials, and the impact of cancer treatment on physical or cognitive function is typically not captured in clinical trials (Hutchins et al., 1999; Talarico ”
Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review (2018, positive): “The additional cost of participating under these circumstances biases participation to those in higher socioeconomic levels [5,103,115,119], particularly in oncology studies.”