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Updated: Oct 7, 2025
A Melanoma Patient-Derived Xenograft Model
Published on: May 20, 2019
Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials
Reema Shah1, Nil Patel2, Yasha Patel1
1Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, Piscataway, NJ, USA.
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 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.
Insights
Melanoma clinical trials enroll younger patients than the general population. This underrepresentation of elderly individuals may limit the applicability of trial results for older melanoma patients.
Area of Science:
- Oncology
- Dermatology
- Clinical Trials
Background:
- Melanoma incidence is rising globally, particularly in European, New Zealander, and Australian populations.
- The average age of melanoma diagnosis is 65 years (mean) and 59 years (median).
- Phase 3 trials are crucial for evaluating treatment efficacy in representative patient populations.
Purpose of the Study:
- To analyze patient age demographics in melanoma phase 3 clinical trials.
- To identify disparities between clinical trial age demographics and epidemiological data.
Main Methods:
- A literature review was conducted using clinicaltrials.gov.
- Patient mean and median ages were extracted from 35 eligible melanoma trials.
- Weighted mean and median ages were calculated.
Main Results:
- The weighted mean age in melanoma trials was 55.85 years.
- The weighted median age in melanoma trials was 55.14 years.
- Melanoma clinical trials enroll patients younger than the epidemiological averages.
Conclusions:
- Elderly patients are underrepresented in melanoma clinical trials.
- This age disparity may limit the real-world application of clinical trial findings for older adults.
- Further research is needed to ensure equitable trial participation across all age groups.
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