The overall aging of the population has resulted in a marked increase in the number of older patients with cancer. These patients have specific needs that are different from those of the younger population. Cancer clinical trials have included an inadequate number of older patients, resulting in lack of meaningful data to make evidence-based decisions for this population. As a result, clinicians have to extrapolate data from younger and healthier patients. There are a number of reasons for this under-representation, including a design and implementation structure for clinical trials that does not meet the needs of this vulnerable population. Issues that need to be addressed include alterations in eligibility criteria to make them less restrictive by accounting for multiple comorbidities and prior malignancy and endpoints specific for older patients, such as quality of life, changes in function, and maintenance of independence. Other issues specific to the older population include alterations in dose-limiting toxicity, measures of treatment-related toxicity, and polypharmacy. Phase I trials can be appropriate for older patients but need to be tailored to their needs. Some form of g
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