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Discontinuation and nonpublication of nasopharyngeal carcinoma clinical trials

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机构: [1]Department of Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou 510060, PR China. [2]Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital and Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, Guangdong, PR China. [3]Department of Dermatology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, PR China. [4]Department of Oncology, Senior Ward and Phase I Clinical Trial Ward, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan 610000, PR China.
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关键词: Nasopharyngeal carcinoma Discontinuation Nonpublication Clinical trial

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To determine the extent of research waste in the field of nasopharyngeal carcinoma (NPC).In this cross-sectional study, we explored the rates, causes and predictors of discontinuation and nonpublication of NPC clinical trials. The sample was derived using the ClinicalTrials.gov advanced search function. Adjusted logistic regression was used to ascertain the effect of trial characteristics on completion and publication status. If a trial discontinuation explanation or publication status could not be determined through the systematic search, the corresponding author was emailed.Ultimately, 311 NPC clinical trials were included (255 [82.0 %] completed and 56 [18.0 %] discontinued trials). The most common reason for trial discontinuation was poor accrual (50 %, 23/46). Industry funding (adjusted OR, 3.12; P = 0.003) and recurrent/metastatic setting (adjusted OR, 11.95; P = 0.003) were significantly associated with increased likelihood of trial discontinuation. Of the 207 completed trials included in the publication query, 141 (68.1 %) were published in peer-reviewed journals, 10 (4.8 %) had results only available on ClinicalTrials.gov, and 56 (27.1 %) remained unpublished 3 or more years after trial completion. Radiation with or without pharmacologic interventions significantly increased the potential of publication (adjusted OR, 3.20; P = 0.048). Among published trials, the median time to publication was 28.47 months (interquartile range, 15.27-44.98 months).We identified the difficulties inherent in NPC clinical trials from completion to publication. This represents considerable research waste in NPC, thus raising ethical concerns about the concealment of clinical data and futile patient participation and attendant risks.Copyright © 2023 Elsevier Ltd. All rights reserved.

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出版当年[2023]版:
大类 | 2 区 医学
小类 | 2 区 牙科与口腔外科 3 区 肿瘤学
最新[2023]版:
大类 | 2 区 医学
小类 | 2 区 牙科与口腔外科 3 区 肿瘤学
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出版当年[2023]版:
Q1 DENTISTRY, ORAL SURGERY & MEDICINE Q2 ONCOLOGY
最新[2023]版:
Q1 DENTISTRY, ORAL SURGERY & MEDICINE Q2 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2023版]

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第一作者机构: [1]Department of Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou 510060, PR China.
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通讯机构: [1]Department of Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou 510060, PR China. [4]Department of Oncology, Senior Ward and Phase I Clinical Trial Ward, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan 610000, PR China.
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