Posted online on November 15, 2004 on www.jco.org [1].Read the original study [2]A new study in the Journal of Clinical Oncology (JCO) has found that cancer patients over the age of 65 are significantly under-represented in cancer clinical trials. Researchers reported that other health conditions and their treatment, as well as concerns about health-care costs, lack of social or home care support, and difficulty accessing hospitals or cancer clinics, may limit elderly participation in clinical trials.Researchers conducted an analysis of 28,766 people participating in 55 clinical trials between 1995 and 2002 evaluating treatment for leukemia, lymphoma, and cancers of the breast, lung, colon, ovary, pancreas, and central nervous system. The number of people for each age group and each cancer type was compared to the corresponding number of people in the U.S. cancer population.Researchers found that although patients 65 years and older make up 60% of cancer patients in the United States, only 36% of them participate in clinical trials for cancer drugs. Patients 70 and older made up 46% of the U.S. cancer population, but only 20% of the study population, and patients 75 and older represented 31% of the U.S. cancer population, but only 9% of the study population.Researchers suggest that elderly patients are less likely to be asked or may be less willing to enroll in clinical trials because of concerns that the treatment will be ineffective or cause debilitating side effects and a reduced quality of life.In contrast, researchers reported that elderly patients were not under-represented in trials of breast cancer hormonal therapies, which are widely perceived by both patients and physicians to be well-tolerated and effective in women of all ages, including older women.Researchers noted that if older patients do not participate in clinical trials, the treatments resulting from those trials may not be appropriate for them, and underscored the importance of developing clinical trials that may allow greater participation of elderly patients.What Does This Mean for Patients?Clinical trials are necessary for determining whether treatments are safe and effective. Patients who participate in clinical trials receive state of the art care, and access to promising new therapies that would not otherwise be available.The Food and Drug Administration (FDA) recommends that drugs be studied in all age groups for which they will have significant utility, including the elderly, so that the true risks and benefits can be assessed.Cancer patients should talk with their physicians about available clinical trials, as well as the risks and benefits of participation. Elderly patients in particular should ask their physicians about the treatments involved in a particular trial, as well as any side effects that might result from that treatment.In the meantime, the medical community is working to design clinical trials that will better address the needs of cancer patients over the age of 65, including less restrictive eligibility requirements and treatments that have fewer side effects.