趣赢平台’s Isabel 国民 on Supporting 临床研究 of Emerging Infectious Diseases

伊莎贝尔·特雷霍斯，药剂师.D., M.Sc., is a 趣赢平台 Senior Study Director with extensive experience providing pharmacy and monitoring support, as well as project management for clinical research in the U.S.非洲、亚洲和拉丁美洲. As project manager for the Mexican Emerging Infectious Disease 临床研究 Network (LaRed)—established with the National Institute of Allergy and Infectious Diseases (NIAID) in 2009 in response to the global outbreak of H1N1—she has provided critical support to their joint clinical research on emerging infectious diseases. Dr. 国民’ work for LaRed has included management support of 3 influenza/influenza-like illness studies and a study examining the natural history of the Zika infection in Tapachula, 墨西哥的恰帕斯. She is also managing a study for the National Institute of Child Health and Human Development (NICHD) on the outcome of maternal exposure of the Zika virus on offspring.

Q: Dr. 国民, you manage a considerable number of clinical research trials (CRTs) involving several countries and at least 2 different 语言s. 你的工作涉及监管支持, 现场准备, and operational assistance; data management; training; and administrative and programmatic support. How would these activities differ in the face of a clinical trial conducted during a crisis such as 新型冠状病毒肺炎?

A: The pandemic itself modifies the conduction of clinical trials, and it is a rapidly evolving situation affecting the availability of staff and supplies, 参与者使用卫生设施的限制, 优先级的变化, 监管机构指导方针的变化, 等. The responsibilities are magnified in a global pandemic such as 新型冠状病毒肺炎 because the number of countries involved are so much greater, and building capacity and sustaining a CRT entails understanding the culture, 语言, 政治, 资助机制, 以及每个国家的法规. When I managed the collaborative clinical program for the Mexico Ministry of Health and NIAID in response to the global outbreak of H1N1 in 2009, 我们只有一种语言和一种文化需要支持. 新型冠状病毒肺炎 CRT将涉及更多语言和文化.

Q: You are heading a Zika study for LaRed in Mexico and 2 Zika projects for NICHD: a cohort study of Zika in infants and pregnancy, and an international cohort study of children born to women infected with Zika during pregnancy. 这些研究的目的是什么?

A: 在墨西哥的拉里德, we’ll be examining the long-term neurological complications in individuals exposed to Zika in Mexico. 在一项由联合国儿童健康与发展中心资助的国际研究中, we’re assessing the strength of the association with the Zika infection during pregnancy with adverse maternal/fetal outcomes and the risk of vertical transmission. 在另一项研究中, we are looking at the developmental outcomes of children exposed to Zika in the womb. This involves evaluating 400 children ranging in age from 18 months to 3.2年期间5年.

Q: What challenges will you confront in these studies taking place in Latin America and the U.S. that would differ from the challenges of such studies of 新型冠状病毒肺炎?

A: As discussed before, the pandemic itself is an evolving challenge. 另外, 有语言障碍, 文化的挑战, 融资物流, and regulatory differences regarding Zika just as there would be to study the coronavirus. Databases will have to be provided in the country’s native 语言 and managed, 分析了, 并以多种语言报道. 但这些障碍并非不可逾越, and we’ve been very successful in managing and completing these kinds of dual-语言 clinical research trials.