青少年参与性传播感染临床试验情况：现有注册研究综述
Inclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections: A Review of Existing Registered Studies.
作者信息
Hoffman Lily F, Francis Neferterneken K, Catallozzi Marina, Francis Jenny K R, Stanberry Lawrence R, Rosenthal Susan L
机构信息
Department of Pediatrics, College of Physicians and Surgeons, Columbia University Medical Center, New York, New York.
Department of Pediatrics, College of Physicians and Surgeons, Columbia University Medical Center, New York, New York; NewYork-Presbyterian Hospital/Morgan Stanley Children's Hospital, New York, New York; Heilbrunn Department of Population and Family Health, Mailman School of Public Health, Columbia University Medical Center, New York, New York.
出版信息
J Adolesc Health. 2016 May;58(5):576-8. doi: 10.1016/j.jadohealth.2016.01.007. Epub 2016 Mar 12.
PURPOSE
Despite their heightened risk of sexually transmitted infections, minor adolescents (<18 years old) are often excluded from clinical trials. The results of trials of adults should not be assumed to generalize to minors.
METHODS
Two public clinical trial registries were first searched using microbicide or PrEP with STD, STI, HIV, or HSV and with gel, ring, or film, and then searched using prevention/sexually transmitted diseases with gel. Studies were classified based on the information provided in the registry.
RESULTS
The searches yielded 111 unique studies. Only 9.0% (n = 10) included minors. They were under-represented in Phase 0-II studies and over-represented in studies of individuals infected with human immunodeficiency virus.
CONCLUSIONS
Minor adolescents should be included during all stages of development and before they have acquired an infection. Future studies should examine the challenges of including minor adolescents in trials and how to overcome these barriers.
目的
尽管未成年青少年（<18岁）感染性传播感染的风险更高，但他们通常被排除在临床试验之外。不应假定成人试验的结果适用于未成年人。
方法
首先在两个公共临床试验注册库中进行检索，检索词为杀微生物剂或暴露前预防（PrEP），并搭配性传播疾病、性传播感染、艾滋病毒或单纯疱疹病毒，以及凝胶、阴道环或薄膜，然后使用预防/性传播疾病与凝胶进行检索。根据注册库中提供的信息对研究进行分类。
结果
检索共得到111项独特的研究。只有9.0%（n = 10）纳入了未成年人。他们在0-II期研究中的代表性不足，而在感染人类免疫缺陷病毒个体的研究中代表性过高。
结论
未成年青少年应在发育的各个阶段以及感染之前被纳入研究。未来的研究应探讨将未成年青少年纳入试验的挑战以及如何克服这些障碍。
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