Bridging research gaps in geriatric oncology: unraveling the potential of pragmatic clinical trials.

ABSTRACT

PURPOSE OF REVIEW This review examines the role of pragmatic clinical trials (PCTs) in addressing the underrepresentation of older adults with cancer (OAC) in clinical trials. Focusing on real-world evidence (RWE), it aims to provide a comprehensive overview of PCT utilization, emphasizing their potential to enhance treatment decisions and patient outcomes. Existing knowledge gaps in PCT implementation are also discussed. RECENT FINDINGS: PCTs are identified as effective tools to include OACs with comorbidities and complex conditions in research, bridging the representation gap. Despite their proven value in healthcare provision, their application in OAC contexts remains limited, hindering comprehensive understanding and inclusivity in clinical trials. SUMMARY: While randomized controlled trials (RCTs) are considered the gold standard in oncology research, OACs have historically been excluded, perpetuating underrepresentation. Furthermore, even in current oncology clinical development trials, this demographic continues to be underrepresented. PCTs offer a valuable avenue for the identification and evaluation of therapies within authentic RW contexts, encompassing various healthcare settings, such as hospitals, clinics, and physician practices. RCTs and PCTs complement one another, and the utilization of PCTs has the potential to inform clinical decision-making across the OACs entire treatment trajectory.