Under-Representation of Older Adults in Cancer Registration Trials: Known Problem, Little Progress

Abstract

The oncology literature from the last decade is replete with articleslamentingthescarcityofdatatoguidetreatmentdecisionsforthe elderly population with cancer. With the aging of the United States and worldwide population and the known association between older ageandcancer, 1 cliniciansandresearchersunderstandtheimportance of studying the efficacy and toxicity of cancer therapies in this at-risk population. The importance of this knowledge is highlighted by the US Food and Drug Administration in its Guideline for the Study of Drugs Likely to Be Used in the Elderly, 2 which advocates enrollment of older adults in clinical trials as a means to understand treatment effects among differing populations. Almostadecadeago,JournalofClinicalOncologyhighlightedthe under-representation of older adults in registration trials for new cancertherapiesfrom1992to2002.Talaricoetal 3 showedtheproportions enrolled onto registration trials versus the proportions in the overall populations age 65, 70, and 75 years were 36%, 20%, and9%comparedwith60%,46%,and31%,respectively.Theauthors surmised that decline in functional reserve, increased comorbid con