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人类乳头瘤病毒 (HPV) 试验:临床试验注册表的横截面分析

Edison Johannes Mavundza¹, Tshiamo Moshading Mmotsa¹, Duduzile Ndwandwe¹

¹Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa.

Human vaccines & immunotherapeutics

|August 28, 2024

概括

临床试验的未来注册对于伦理研究至关重要. 这项研究发现,许多人乳头瘤病毒 (HPV) 试验被追溯地注册,强调需要改进注册实践.

科学领域:

临床研究临床研究
公共卫生公共卫生
流行病学流行病学

背景情况:

临床试验注册对于研究的完整性和透明度至关重要.
未来的注册可以防止不当行为和研究重复.
人类乳头瘤病毒 (HPV) 研究需要强有力的试验监督.

研究的目的:

分析全球注册的人类乳头瘤病毒 (HPV) 临床试验的情况.
评估在HPV试验中遵守潜在的注册指南.
为了确定HPV试验特征和赞助的趋势.

主要方法:

在国际临床试验注册平台 (ICTR) 上注册的试验的横截面调查.
数据提取包括注册,位置,招聘状态,参与者的性别,试验阶段和赞助商类型.
使用微软Excel进行的描述性分析.

主要成果:

在1999年至2023年期间,确定了1632个HPV试验.
大多数试验都在clinicaltrials.gov和retrospectively.gov上注册.
北美是主要的试验地点;许多试验缺乏阶段信息,并由医院赞助.

结论:

全球范围内存在大量的HPV临床试验.
观察到广泛的追溯注册和不完整的数据字段,违反了道德标准.
临床试验注册表应该促进未来的注册和数据的完整性.

关键词:

人类乳头瘤病毒人类乳头瘤病毒临床试验登记册临床试验登记册临床试验是指临床试验中的临床试验.横截面分析横截面分析国际临床试验注册平台国际临床试验注册平台

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