No abstract

No abstract

The mean and median ages of diagnosis of multiple myeloma range from 70 to 73 years old, with 63% of patients being over the age of 65. Phase 3 clinical trials are designed to study efficacy in the target disease population and are meant to have the most representative subject pool. The purpose of this review is to identify the age demographic of subjects participating in interventional phase 3 clinical trials that aim to treat multiple myeloma and to determine if they encompass the true age demographic of the disease. To complete this review, a search of phase 3 multiple myeloma research trials with reported results was conducted on clinicaltrials.gov, a national, publicly available resource listing clinical trials. Reported mean or median ages of subjects were identified for each trial, and adjusted averages of these values were calculated. Data from 81 clinical trials were assessed, with 42 trials reporting an average mean age of 65.78 years and 15 trials reporting an average median age of 63.29 years. Based on these results, it was determined that the clinical trials reported in this study enrolled patients that were younger than the true age demographic of the disease. There is an unmet need in research in the older population of patients with multiple myeloma, and this may hinder the generalizability and utility of clinical trial results.

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.