Keywords: elderly patients, study design, endpoints
This talk will review possible study designs meant to evaluate therapeutic interventions in elderly patients with cancer. A majority of cancer diagnoses occur in patients older than 65 years. The number of older adults with cancer will grow over the next decade as the result of the aging population. Relatively little is known about the best way to balance the risks and benefits of existing cancer therapies in older patients because clinical trials either excluded them or these patients are vastly underrepresented even if not excluded. It is also the case that most clinical trials do not include end points of greatest importance to older cancer patients, such as preservation of function, cognition, and independence. This presentation will review study designs that have been used in the past as well as possible study designs that could be used in the future that would provide more information on the impact of therapies on older/frailer adults. The advantages and disadvantages of the different approaches will be explored.