The number of Americans over age 65 will double to 69.4 million in the next thirty years and the number of Americans over age 85 will quadruple. Because treatment of cancer in older people is often complicated by co-morbidities, making some therapies that are effective in younger people inappropriate for older patients, it is important to evaluate new therapeutic approaches in the Medicare population. Based on the clinical research budgets of the various programs of the National Institutes of Health, it has been estimated that cancer trials comprise approximately 30-40 percent of all clinical trials in the United States. Assuming accrual rates and eligibility criteria for cancer trials are similar to those in other disciplines, an estimated 40,000-53,000 Medicare beneficiaries can be expected to enroll in clinical trials. While Medicare policy officially denies coverage of investigational therapies, the program often covers the costs of care provided in clinical trials if a patient would otherwise be treated.
Circumstances triggering denials are arbitrary and random.