Clinical Studies Network Core Service
The BARDA Strategic Plan (2011-2016) set forth a goal to provide enabling core assistance services to aid medical countermeasure (MCM) developers with essential product development tools and services. Part of the strategy was BARDA’s establishment of a Clinical Studies Network (CSN) that can provide comprehensive (Phase 1-4) clinical study services to help evaluate the safety, dosage, pharmacokinetics/pharmacodynamics and efficacy of MCM candidates. In 2014, BARDA created its CSN by partnering with five (5) Contract Research Organizations including TRI, ClinicalRM, Emmes, Rho and PPD.
The CSN became immediately engaged in the Ebola Response in 2015 as part of BARDA’s National MCM Response Infrastructure. The CSN worked with CDC, the Sierra Leone Ministry of Health, and the Sierra Leone College of Medicine and Allied Health Sciences to conduct the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). The STRIVE study began enrolling healthcare workers and other front line workers in April, 2015, and over 8,000 subjects received an investigational vaccine to prevent Ebola. The study will assess the safety and immunogenicity of the vaccine. BARDA’s CSN is providing staff training, clinical site development and monitoring, and data management, biostatistics, safety, cold chain, and logistics support.
In March, 2016, the CSN launched BARDA’s first sponsored trial, the BARDA Ready in Times of Emergency (BRITE) study, evaluating safety and immune responses of H5N1 pre-pandemic influenza vaccines and adjuvants that have been stored in the national stockpile for up to 10 years. The study is being conducted at 6 US sites selected in part because of their proximity to poultry farms or research laboratories in order to target workers at higher risk of exposure to avian influenza. The results of this study are expected to inform future decisions on the length of time pre-pandemic influenza vaccines and adjuvants maintain their activity and are safe to store in the National Pre-Pandemic Influenza Vaccine Stockpile in order to help protect the US population.
The CSN also worked with BARDA’s Chemical MCM Program to compile data for a supplemental FDA New Drug Application for midazolam (an anticonvulsant drug) administered by auto-injector to treat neurotoxin-induced seizures. BARDA-supported FDA approval of intramuscular midazolam for emergency treatment of prolonged seizures in children and adults will ensure that this vital MCM is widely available to first-responders.
The CSN plans in 2016-2018 to conduct additional clinical studies linked to BARDA’s areas of investment, including heterologous prime boost studies of different influenza vaccines in the National Pre-Pandemic Influenza Vaccine Stockpile, studies of an anthrax vaccine for an elderly population, and studies of candidate therapies against MERS-CoV infection in the Middle East. In conjunction with partner programs in the National MCM Response Infrastructure, these activities will increase BARDA’s readiness to respond to biothreats and public health emergencies.
Clinical Studies Network contract awardee map (PDF - 160KB)