The changing landscape of phase II/III metastatic sarcoma clinical trialsanalysis of ClinicalTrials.gov
The changing landscape of phase II/III metastatic sarcoma clinical trialsanalysis of ClinicalTrials.gov
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II/III 期转移性肉瘤临床试验的变化情况ClinicalTrials.gov 分析
DOI：
10.1186/s12885-018-5163-2
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发表时间：
2018-12-13
期刊：
影响因子：
3.8
通讯作者：
Zhang, X.
中科院分区：
文献类型：
--
作者：
Que, Y.;Xiao, W.;Zhang, X.
背景设计良好的临床试验对于验证新的治疗方法和确保肉瘤的循证治疗具有重要意义。本研究的目的是提供一个全面的景观转移性或晚期肉瘤临床试验的特点，使用大量的资源ClincialTrials.gov database.MethodsWe确定了260,755试验注册与ClinicalTrials.gov在过去的20年，其中277人有资格列入。确定每项试验的基线特征。对这些试验进行了系统的回顾，以验证其分类为2008年之前注册的96项试验和2008年至2017年注册的181项试验。结果我们发现，在过去的十年中，转移性和晚期肉瘤试验主要是II-III期研究（p=0.048），更可能为2组（分别为17.7%和35.3%; p=0.007），更有可能使用随机（13.5% vs 30.4%; p=0.002）和双盲（2.1% vs 9.4%; p=0.024）分配。此外，在过去10年期间，转移性肉瘤试验更有可能在亚洲进行。靶向治疗和免疫治疗更常见（71.8%比37.5%; P
BackgroundWell-designed clinical trials are of great importance in validating novel treatments and ensuring an evidence-based approach for sarcoma. This study aimed to provide a comprehensive landscape of the characteristics of metastatic or advanced sarcoma clinical trials using the substantial resource of the ClincialTrials.gov database.MethodsWe identified 260,755 trials registered with ClinicalTrials.gov in the last 20years, and 277 of them were eligible for inclusion. The baseline characteristics were ascertained for each trial. The trials were systematically reviewed to validate their classification into 96 trials registered before 2008 and 181 trials registered between 2008 and 2017.ResultsWe found that in the last decade, metastatic and advanced sarcoma trials were predominantly phase II-III studies (p=0.048), were more likely to be 2 arms (17.7% vs 35.3%, respectively; p=0.007), and were more likely to use randomized (13.5% vs 30.4%; p=0.002) and double-blinded (2.1% vs 9.4%; p=0.024) assignment than trials registered before 2008. Furthermore, in the last 10-year period, metastatic sarcoma trials were more likely to be conducted in Asia. Treatment involving target therapy and immunotherapy were more common (71.8% vs 37.5%; p