COVID-19 Clinical Trials: Planning, Execution, Ethics, and Participant Testimonies from Brazil

Date: 

Thursday, April 21, 2022, 2:30pm to 4:00pm

Location: 

677 Huntington Ave, Kresge Building, 1st floor, room 110 (next to Sebastian’s Café/HSPH cafeteria) - Boston, MA

A limited number of Harvard affiliates can register to participate in this multidisciplinary, in-person panel aimed at discussing the complexities of the COVID-19 clinical trials from the perspectives of those planning the trials to the volunteers on the receiving end of the vaccines. Besides being able to participate in the discussion, registrants will also have access to view the Brazilian documentary "Volunteer ***1864," which portrays the experiences of ordinary Brazilians who volunteered to participate in COVID-19 clinical trials, directed by panelist Sandra Kogut.

Speakers: Caroline Buckee, Associate Director and Professor, Center for Communicable Disease Dynamics, Department of Epidemiology, HSPH; Richard Cash, Senior Lecturer on Global Health, HSPH; Ai-ris Yonekura Collier, Co-Director, Clinical Trials Unit, Center for Virology and Vaccine Research- Beth Israel Deaconess Medical Center; Sandra Kogut, Filmmaker and Radcliffe-Film Study Center Fellow, Harvard Radcliffe Institute
Moderated by: Marcia Castro, Andelot Professor of Demography; Chair of the Department of Global Health and Population, Harvard T.H. Chan School of Public Health

Dr. Caroline Buckee is a Professor of Epidemiology and Associate Director of the Center for Communicable Disease Dynamics at Harvard T.H. Chan School of Public Health. Her work is focused on understanding the mechanisms driving the spread of infectious diseases that impact the most vulnerable populations worldwide, particularly malaria. Before coming to Harvard, Dr. Buckee completed a D.Phil. at the University of Oxford, and Omidyar and Wellcome Trust fellowships at the Santa Fe Institute and the Kenya Medical Research Institute, respectively, where she analyzed malaria parasite evolution and epidemiology. Dr. Buckee’s group uses a range of mathematical models, experimental and genomic data, and “Big Data” from mobile phones and satellites to understand how human pathogens spread and may be controlled. Her work has appeared in high profile scientific journals such as Science and PNAS, as well as being featured in the popular press, including CNN, The New Scientist, Voice of America, NPR, and ABC. Dr. Buckee was featured as one of MIT Tech Review’s 35 Innovators Under 35, a CNN Top 10: Thinker, and Foreign Policy Magazine’s 100 Global Thinkers.

Dr. Cash and his colleagues conducted the first clinical trials of Oral Rehydration Therapy (ORT) in adult and pediatric cholera patients and patients with other infectious causes of diarrhea at the Cholera Research Laboratory (now ICDDR,B) in Bangladesh. Other in-country studies included the first field trials and community-based trials of ORT and the use of amino acids (glycine) as an additional substrate. He was the Principal Investigator of the Applied Diarrheal Disease Research (ADDR) Project, a program that assisted developing country scientists to hone their research skills by conducting their own research projects. Over 150 studies, involving more than 350 investigators were funded in twelve countries in Africa, Asia, and Latin America, leading to over 275 publications. Research priorities included: behavioral studies of care takers and providers; foods and fluids; prevention of diarrhea; persistent diarrhea; and acute respiratory infection and nutrition. Dr. Cash also directed a program in research ethics that focused on training for fellows from Asia, and research ethics workshops at HSPH and in 12 countries. He is the senior editor of “Casebook on Ethical Issues in International Health Research”, a WHO publication.

Dr. Ai-ris Yonekura Collier is a physician-scientist specializing in high-risk pregnancy care in the Department of Obstetrics and Gynecology at BIDMC. The goal of her translational research is to characterize the maternal cellular immune phenotype in pregnancy disorders like preeclampsia and fetal growth restriction and in the setting of infectious disease like Zika virus or SARS-CoV-2. During the COVID-19 pandemic, she was Principal Investigator leading the hospital-wide COVID-19 Biorepository and a co-investigator for the Ad26.COV2.S COVID-19 vaccine booster trial. This work builds upon prior work performing longitudinal observational studies in pregnant individuals exposed or infected with Zika virus and creating large clinical biospecimen repositories for translational immunologic studies in pregnancy. In addition to the work in the CTU, she is an enthusiastic educator and advocate for inclusion of pregnant and lactating individuals in observational and interventional clinical trials.

Sandra Kogut is a filmmaker most recently known for Campo Grande (2015) and Three Summers (2019). At Radcliffe, she is creating a large-scale archive of the digital present by exploring how ordinary people effectively create a representation of themselves through their online activities; the archive will then serve as the basis of a documentary film.

Marcia Castro is Andelot Professor of Demography, Chair of the Department of Global Health and Population at the Harvard TH Chan School of Public Health, and Chair of the Brazil Studies Program of the David Rockefeller Center for Latin American Studies (DRCLAS). Her research focuses on the development and use of multidisciplinary approaches to identify the determinants of infectious disease transmission in different ecological settings to inform control policies. She has more than 15 years of collaboration with Brazilian researchers, Health Secretariats, and the Ministry of Health particularly related to infectious diseases. She made important contributions during recent public health emergencies (the Zika virus epidemic and the COVD-19 pandemic). Castro has projects on malaria, COVID-19, arboviruses, infant/child mortality and development, and climate change in the Brazilian Amazon. Specifically, on COVID-19 she has been assessing the spatiotemporal pattern of COVID-19 spread in Brazil, mortality, and fertility changes due to the pandemic, risk factors for mortality, and vaccine effectiveness. She serves on several advisory boards in Brazil, including the Institute for the Studies of Health Policies (IEPS), the Science Center for Early Childhood (NCPI), and Instituto Todos Pela Saúde (ITpS). She earned a PhD in Demography from Princeton University.

Presented in collaboration with the Department of Global Health and Population, Harvard T.H. Chan School of Public HealthBrazilian Student Association at Harvard T.H. Chan School of Public Health, and Center for Virology and Vaccine Research (CVVR), Beth Israel Deaconess Medical Center