Many questions remain about Zika and its current impact on the Haitian population. Until more answers surface, BWH and Partners In Health(PIH) staff strive to find the best solutions for women, men, and children who may be adversely affected by the virus.
Louise Ivers, MD, MPH, of the BWH Division of Global Health Equity and senior health and policy advisor for PIH, answers questions about the mosquito’s resiliency, efforts to control it in Haiti and how PIH is working to prevent Zika infections and treat those who might be suffering from complications.
When Indian regulators implemented a series of new clinical trial regulations in 2013, clinical trials in India ground to a halt. Under the new regulations, clinical trial sponsors would be responsible for compensating participants who were injured or died during the trial, even if the death or injury was unrelated to the trial itself. Virtually all clinical trials sponsors, including the National Institutes of Health, stopped initiating any new trials. Less than two percent of the world’s clinical trials were unfolding in a country that is home to one-seventh of the world’s population. Barbara Bierer, MD, co-director of the Multi-Regional Clinical Trials (MRCT) Center, had been following the dilemma in India closely.
Bierer and Mark Barnes, then at Harvard University, had launched the MRCT Center in 2011 to define and address emerging issues in global clinical trials. By bringing together a variety of stakeholders, the center aims to find solutions to improve the integrity, safety and rigor of trials around the world.
After the new regulations were announced, Bierer and her colleagues reached out to government officials and industry and academic stakeholders in India, organized roundtable discussions and, over the course of more than 14 visits to the country, worked closely with Indian leaders to help to develop fair amendments to the earlier legislation and address the issues resulting from regulatory reform. The MRCT Center has been involved in training, and in developing scalable tools that will assist the appropriate application of the regulations such as a tool to assess causality to determine whether a death or injury is directly linked to a clinical trial. Their efforts continue today.