Clinical trial design in older adults with cancer—The need for new paradigms

Increasing age is directly associated with an increasing risk of cancer, and persons over 65 constitute the fastest growing group in the United States. Not only do older adults comprise the majority of cancer patients, at the same time, they have also been vastly underrepresented in clinical trials. As a result, little evidence-based data exist to guide their course of treatment. Alternative trial designs and expanded research evaluations are needed to guide cancer therapy in this population, which is estimated to account for 20% of all Americans by the year 2030. In this review, after examining the status quo, we propose ways to correct the widespread underreporting and underrepresentation of older adults in cancer trials, and highlight existing barriers to trial enrollment. We also outline specific issues of treatment and survivorship as they pertain to older adults, including function, clinical benefit, quality of life, polypharmacy, toxicity, and comorbidity.