Al Khatib Abdulrahman Nasir, Al Masri Rama, Al Hayek Sa'ed, Yaser Sameer, Jaber Omar, Saleh Yacob
Faculty of Medicine, University of Jordan, Amman, Jordan.
Department of Internal Medicine, University of Michigan Health Sparrow Hospital, Lansing, Michigan, USA.
Proc (Bayl Univ Med Cent). 2024 Dec 18;38(2):179-182. doi: 10.1080/08998280.2024.2439771. eCollection 2025.
Melanoma is a common cancer worldwide. Introduction of new treatments through clinical trials is essential to reduce the global burden from melanoma; however, it is estimated that 22% of oncological clinical trials are terminated early. We conducted the first cross-sectional study to assess melanoma clinical trial termination and nonpublication with an aim to guide scientists conducting such trials.
We identified all phase III/IV clinical trials evaluating melanoma therapies in the ClinicalTrials.gov database between 2010 and 2024. For each trial, we extracted data on the trial's status, melanoma stage, melanoma subtype, included age, funding sources, trial locations, publication status, and reasons for termination. A descriptive and frequency analysis was performed in JASP 0.19 software.
A total of 108 trials were analyzed; the majority of trials included stage III/IV melanoma (n = 95), and cutaneous melanoma was the most common subtype. Only 15 trials included pediatric patients. Industrial funding accounted for 74% (n = 80) of trials' financing. Most of the trials were conducted internationally in North America, Europe, Australia, and New Zealand, with a few trials conducted in South Africa (n = 1), South America (n = 1), or China (n = 5). Early termination was observed in 21% (n = 23) of trials, with no association between early termination and melanoma stage, subtype, age, funding source, or trial locations. Notably, the most common reason for early termination was publication of interim efficacy and safety results (n = 14/23).
Our study confirms that early termination of phase III and IV melanoma trials doesn't raise a significant concern; however, diversified funding and broader geographic representation are needed to create more equitable and inclusive trials. We also suggest conducting further cross-sectional studies on phase I/II melanoma trials.
黑色素瘤是全球常见的癌症。通过临床试验引入新疗法对于减轻全球黑色素瘤负担至关重要；然而，据估计22%的肿瘤学临床试验会提前终止。我们开展了第一项横断面研究，以评估黑色素瘤临床试验的终止和未发表情况，旨在指导开展此类试验的科学家。
我们在ClinicalTrials.gov数据库中识别出2010年至2024年间所有评估黑色素瘤疗法的III/IV期临床试验。对于每项试验，我们提取了试验状态、黑色素瘤分期、黑色素瘤亚型、纳入年龄、资金来源、试验地点、发表状态以及终止原因等数据。在JASP 0.19软件中进行描述性和频率分析。
共分析了108项试验；大多数试验纳入III/IV期黑色素瘤（n = 95），皮肤黑色素瘤是最常见的亚型。只有15项试验纳入了儿科患者。行业资金占试验资金的74%（n = 80）。大多数试验在北美、欧洲、澳大利亚和新西兰等国际范围内开展，少数试验在南非（n = 1）、南美（n = 1）或中国（n = 5）进行。21%（n = 23）的试验出现提前终止，提前终止与黑色素瘤分期、亚型、年龄、资金来源或试验地点之间无关联。值得注意的是，提前终止最常见的原因是中期疗效和安全性结果的发表（n = 14/23）。
我们的研究证实，III期和IV期黑色素瘤试验的提前终止并未引起重大担忧；然而，需要多元化的资金和更广泛的地域代表性来开展更公平和包容的试验。我们还建议对I/II期黑色素瘤试验进行进一步的横断面研究。
