Despite carrying the largest burden of chronic diseases and taking more prescription medications than any other group, older adults are consistently under-represented in clinical trials. The complex, and therefore risky, treatment needs associated with older adults is often what makes sponsors hesitant to include them in a trial. However, a misalignment between the population under investigation and the intended consumer could compromise the external validity of benefit-risk assessments made for launched drugs.
In order to support sponsors in safely ensuring that the research population reflects the intended user, the FDA recently released guidance on the Inclusion of Older Adults in Cancer Clinical Trials. This guidance highlights the need to gather additional data on risk factors for older adults, such as functional status and cognitive function.
During this webinar, Director of Neuroscience at Cambridge Cognition – Dr Kiri Granger – discusses the key considerations when including older adults in clinical trials: with a focus on accurately monitoring cognition.
Watch the full webinar recording: