Early termination and nonpublication of phase III/IV melanoma clinical trials: a cross-sectional study.

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Tác giả: Sa'ed Al Hayek, Abdulrahman Nasir Al Khatib, Rama Al Masri, Omar Jaber, Yacob Saleh, Sameer Yaser

Ngôn ngữ: eng

Ký hiệu phân loại: 359.98583 Specialized combat forces; engineering and related services

Thông tin xuất bản: United States : Proceedings (Baylor University. Medical Center) , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 670465

 INTRODUCTION: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
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