Abstract
Under-representation of the elderly in clinical trials leads to inadequate information on the effect of age with regard to new anticancer treatments. The exclusion of elderly patients from cancer experimentation, often due to limiting medical or psychosocial factors, appears to also stem from misconceptions about aging and frailty. Limited data on elderly cancer patients enrolled in clinical trials suggest that age itself, in the absence of severe concomitant illnesses or psychological, cognitive or functional impairment, is not an independent risk factor for either increased toxicity or lack of treatment efficacy. Prospective benefits of inclusion of the elderly in clinical trials must be weighed against exposing individual patients to potential risks. The medical, ethical and methodological implications of experimentation in the elderly need to be studied in depth. This article reviews ethical issues in cancer clinical trials, focusing on aspects that may deserve special attention when elderly patients are enrolled.
Acknowledgement
I am grateful to Mr William Russell-Edu, Librarian at the European Institute of Oncology in Milan, Italy for his valuable assistance in preparing the manuscript.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.