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JULY 1, 2022 CANCER same drugs off of a clinical trial, so it is imperative to make studies more real world and to evaluate those who most likely will utilize these agents in the future.” They stress that the cancer community also needs to consider and address reasons older adults who are eligible might decline to participate in an offered trial and take whatever steps are necessary to avoid making study participation too onerous for this or any other population—circumstances such as excess clinic visits, blood draws, or other monitoring. Dr. Carducci and Ms. Lansey say that the guidance is critically important to raise awareness and direct attention to barriers that limit inclusion of older adults in clinical trials. “Participants in clinical trials have often been younger and fitter patient populations, even though the drugs, when approved, are utilized in individuals much older than those in the early evaluation trials,” they say, adding that more than half of all cancer cases occur in individuals aged 65 years and older. “While this group is not a monolith, changes in the social determinants of health— like fixed incomes, declining social support, where they live, and limited use of technology or social media—could negatively affect their eligibility, ability to meet participation requirements, or awareness of trials,” they write. “Expanding access, lowering eligibility criteria limits that tend to exclude older individuals, and carefully evaluating the demands placed on participants for trial-related visits to investigation sites should allow more older individuals to participate in cancer clinical trials.” As we work to understand and address the barriers to participation that older adults face, Dr. Carducci and Ms. Lansey say that it is important to be mindful of this population’s intersectional identities and experiences. “This means the barriers they face could be even more complex than just those related to aging because they are also a part of another patient population underrepresented in clinical trials based on their race or ethnicity, gender, place of residence, or other characteristics,” they say. “This awareness will allow us to develop multidimensional interventions to make trials more accessible and participation in them easier.” Cancer Biology Can Change with Aging Beatriz Korc-Grodzicki, MD, PhD, chief of geriatrics service at Memorial Sloan Kettering Cancer Center and clinical professor of medicine at Weill Cornell Medical College in New York City, agrees that this is extremely important guidance. “Most cancer diagnoses and cancer deaths occur in patients aged 65 years [and older] and, with the aging of the world population, the number of older cancer patients will continue to grow,” she says, adding that, although much has been learned about aging and cancer over the last 10 to 20 years, few clinical trials focus on the treatment decisions specifically directed at older adults. In addition, says Dr. Korc-Grodzicki, the biology of certain cancers changes with aging, and the way older patients absorb, distribute, metabolize, and eliminate cancer drugs changes over time; therefore, specific studies on the efficacy of cancer drugs are needed. “Older adults are many times undertreated, and they receive less aggressive therapy, despite the fact that they could tolerate and benefit from cancer-directed therapies. Others are overtreated, resulting in excess toxicity with a big impact on quality of life,” she adds. Dr. Korc-Grodzicki also says it is crucial to find ways to improve the accrual of older adults to clinical trials and to develop research studies that address the knowledge gaps regarding frail adults who would not typically be enrolled in standard trials. “Those gaps affect mostly the care of patients with physiologic or functional decline and those with comorbidities (including cognitive impairment) and polypharmacy,” she says.