Current Challenges Faced by Cancer Clinical Trials in Addressing the Problem of Under-Representation of Older Adults: A Narrative Review.

The number of older adults living with cancer is increasing. There is a clear lack of representation of older adults in clinical trials, including cancer trials. Reasons for this are multifactorial and complex and include protocol, patient and sponsor factors. Potential solutions to overcome issues with trial design include varied methods of recruitment with flexible inclusion criteria. Possible alternatives to randomised trials include prospective cohort studies, pragmatic trials and the use of national population-based data sets. Patient factors may be addressed by integration of geriatric assessment, so patients can be randomised or treated based on their individual needs. Additionally, standard protocols for including older adults with cognitive impairment should be developed, rather than automatic exclusion. Increased effort is needed from sponsors and governing health care bodies to make recruitment of older adults to clinical trials standard.