Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials

BACKGROUND: Melanoma is a skin cancer with a rising worldwide incidence of just over 280,000 individuals with the greatest burden of illness in European, New Zealander, and Australian populations. Patients are diagnosed with melanoma with the mean and median ages being 65 and 59 years old, respectively. Phase 3 trials not only provide a wide representation of the target population but also study the efficacy for a certain intervention. OBJECTIVE: The objective of this literature review is to analyze patient demographics of phase 3 trials for melanoma and identify if there is a true disparity between the clinical trial age demographics and the natural epidemiological age demographics. DATA SOURCES: The authors conducted a search on clinicaltrials.gov, a publicly available resource that lists clinical trials and their data. The reported mean and median ages for each trial were extracted after determining if each trial meets our inclusion criteria. Weighted mean and median ages were calculated using an online calculator. DATA SUMMARY: Data from 35 trials were evaluated with 30 trials reporting a weighted mean age of 55.85 years and 5 trials reporting a weighted median age of 55.14 years. CONCLUSION: Based on the results, melanoma clinical trials enroll patients who are younger than the epidemiological mean and median ages. Due to this underrepresentation of the elderly patients with melanoma, clinical trials may provide limited application for the use of their results.