Westat’s Isabel Trejos on Supporting Clinical Research of Emerging Infectious Diseases

Isabel Trejos, Pharm.D., M.Sc., is a Westat Senior Study Director with extensive experience providing pharmacy and monitoring support, as well as project management for clinical research in the U.S., Africa, Asia, and Latin America. As project manager for the Mexican Emerging Infectious Disease Clinical Research 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. Trejos’ 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, Chiapas in Mexico. 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. Trejos, you manage a considerable number of clinical research trials (CRTs) involving several countries and at least 2 different languages. Your work has involved regulatory support, site preparation, 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 COVID-19?

A: The pandemic itself modifies the conduction of clinical trials, and it is a rapidly evolving situation affecting the availability of staff and supplies, limitations for participants to access health facilities, changes in priorities, changes in guidance from the regulatory agencies, etc. The responsibilities are magnified in a global pandemic such as COVID-19 because the number of countries involved are so much greater, and building capacity and sustaining a CRT entails understanding the culture, language, politics, funding mechanisms, and regulations of each country. 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, we had only 1 other language and 1 other culture to support. A COVID-19 CRT will involve many more languages and cultures.

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. What are the goals of these studies?

A: For LaRed in Mexico, we’ll be examining the long-term neurological complications in individuals exposed to Zika in Mexico. In one of the NICHD-funded international studies, 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. In the other study, 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 3.5 years over a 2-year period.

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 COVID-19?

A: As discussed before, the pandemic itself is an evolving challenge. Additionally, there are language barriers, cultural challenges, logistics for funding, 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 language and managed, analyzed, and reported in multiple languages. But these hurdles are not insurmountable, and we’ve been very successful in managing and completing these kinds of dual-language clinical research trials.