PO.CL02.01 · 临床研究

未完的故事：黑色素瘤临床试验中止与未发表的后果

Unfinished stories: Consequences of melanoma clinical trial discontinuation and non-publication

编号 6438 展板 5 时间 4/21 02:00–05:00 区域 Section 40 主讲 Hadeer Hafez

分会场 Biostatistics in Clinical Trials / Surgical Oncology

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作者与单位 Authors & Affiliations

Hadeer Hafez¹, Abdelrahman Hagag¹, Mohamed Ashraf Mohamed², Mohamed Saad Rakab³, Ismail Zakaria Ismail⁴, Aya Jamal Elkenani⁵, Nada Elmetwally Ahmed¹, Abdelrahman M. Hafez⁶, Doaa Mashaly¹, Ali Tarek Lasheen², Mohamed Abdelsalam¹

¹October 6 University, Faculty of Medicine, Giza, Egypt,²Misr University for Science and Technology, Faculty of Medicine, Giza, Egypt,³Faculty of Medicine, Mansoura University, Giza, Egypt,⁴Faculty of medicine, Misr University for Science and Technology, Giza, Egypt,⁵Faculty of Medicine, Mansoura University, Mansoura, Egypt,⁶Faculty of Medecine, Damietta University, Damietta, Egypt, Damietta, Egypt

摘要 Abstract

中文摘要

背景：黑色素瘤是皮肤癌相关死亡的主要原因之一，临床试验对于推进黑色素瘤治疗选择至关重要。然而，许多试验要么过早终止，要么从未发表，导致关键数据未被报告。这些“未完的故事”阻碍了科学进步，浪费了资源，并限制了知情的临床决策。因此，了解有多少以及哪些因素能够预测未发表或中止的黑色素瘤试验，是提高研究透明度和推进患者最佳治疗的关键。目的：识别黑色素瘤临床研究中止和未发表的程度、特征及相关变量。方法：我们系统检索了ClinicalTrials.gov上截至2025年3月1日的黑色素瘤研究。为考虑同行评审过程中可能的延迟，排除了在过去24个月内完成的研究。使用NCT编号确定发表状态。收集并分析了关于参与者性别、年龄、研究设计、资助来源、干预类型、样本量和试验地点的数据。采用多因素logistic回归识别与试验中止或未发表相关的因素。所有统计分析均使用Jamovi 2.6.24版进行。结果：共有2,144项试验，其中712项（33.2%）已发表，1,215项（56.7%）未发表，217项（10.1%）状态未知。在中止的试验（516项，24.1%）中，仅有59项（11.4%）已发表。在基因干预试验（OR = 0.104，95% CI：0.027-0.401，p=0.001）、操作性干预试验（OR = 0.262，95% CI：0.121-0.567，p<0.001）以及多中心试验（OR = 0.185，95% CI：0.123-0.278，p<0.001）中，未发表状态被发现具有显著性。此外，规模较小（≤500名参与者，p<0.001）或分期较早（1/2期，p<0.001）的研究被中止的可能性显著更高。结论：中止和未发表试验的高发生率凸显了努力完成和/或全面发表黑色素瘤临床研究的重要性，尤其是针对基因和/或操作性治疗和/或小型试验的研究。

查看英文原文 English abstract

Background: Melanoma is a major cause of skin cancer-related death, and clinical trials are essential for advancing melanoma treatment options. However, many trials either are terminated prematurely or are never published, eaving critical data unreported. These “unfinished stories”, hinder scientific progress, waste resources, and limit informed clinical decision-making. Therefore, understanding how many and what factors predict unpublished or discontinued melanoma trials is key to improving the transparency of research and advancing best care for patients. Objective: To identify the extent, characteristics, and variables related to Discontinuation and Non-Publication melanoma clinical investigations. Methods: We systematically searched ClinicalTrials.gov for Melanoma studies up to March 1, 2025. Studies completed within the past 24 months were excluded to account for potential delays in the peer review process. Publication status was identified using NCT numbers. Data on participant gender, age, study design, funding source, type of intervention, sample size, and trial location were collected and analyzed. Multiple logistic regression was used to identify factors associated with trial discontinuation or non-publication. All statistical analyses were conducted using Jamovi version 2.6.24. Results: In total, there were 2,144 trials, with 712 (33.2%) published, 1,215 (56.7%) non-published, and 217 (10.1%) unknown. Of the discontinued trials (516, 24.1%), just 59 (11.4%) were published. Non-publication status was noted to be significant among trials of genetic interventions (OR = 0.104, 95% CI: 0.027-0.401, p=0.001), procedural interventions (OR = 0.262, 95% CI: 0.121-0.567, p<0.001), and in a multicenter trial (OR = 0.185, 95% CI: 0.123-0.278, p<0.001). Also, a study was considerably more probable to be discontinuation if smaller-sized (≤500 participants, p<0.001) or earlier (Phase 1/2, p<0.001). Conclusions: The high frequency of Discontinuation and Non-Publication trials record highlights the importance of efforts toward completing and/or fully publication melanoma clinical investigations, particularly those for genetic and/or procedural treatments and/or smaller trials.

利益披露 Disclosure

H. Hafez, None.. A. Hagag, None.. M. A. Mohamed, None.. M. S. Rakab, None.. I. Z. Ismail, None.. A. J. Elkenani, None.. N. E. Ahmed, None.. A. M. Hafez, None.. D. Mashaly, None.. A. T. Lasheen, None.. M. Abdelsalam, None.

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