The ESMO/SIOG Cancer in the Elderly Working Group pragmatic strategies for clinical trial designs and endpoints in older adults with cancer

Background: Despite cancer affecting mostly older people, patients aged 70 years or older are under-represented in contemporary trials even in the absence of age restrictions. Moreover, trials dedicated to older adults with cancer, including geriatric assessment and management, are limited because of either clinician, patient, or sponsor bias. This article outlines pragmatic strategies to improve trial design and endpoints to facilitate participation of older adults with cancer in clinical trials. Methods: The joint European Society for Medical Oncology (ESMO) and International Society of Geriatric Oncology (SIOG) Cancer in the Elderly Working Group assembled a group of international experts to propose strategies for clinical trial designs and endpoints in older adults with cancer. Expert panel discussions based on review of the evidence were held to reach a consensus. Results: Several obstacles to trial participation such as system barriers (e.g. strict eligibility criteria, poor design, time-consuming procedures) and clinician and individual barriers (e.g. age bias, toxicity concerns, patient preferences, caregiver influences, digital divide) have been identified. Strategies to improve trial accrual and retention include streamlining recruitment, enhancing patient support, leveraging digital tools, and engaging caregivers and patient advocates. Conclusions: We recommend investing in geriatric oncology clinical trial designs that incorporate traditional survival endpoints, as well as prioritise outcome measures affecting quality of life and function in line with the patient goals and preferences.