Clinical Studies Support

The Clinical Studies (DCS) group at BARDA was formed to provide clinical expertise to support BARDA's goals as outlined in BARDA's Strategic Plan 2011-2016. The primary task of DCS is to provide guidance involving safety, tolerability, efficacy and effectiveness of medical countermeasures for a broad array of populations.

DCS is the core group within BARDA that provides program support and oversight of the clinical trials of medical countermeasures. The core service is responsible for assisting programs holding BARDA contracts that include clinical studies. This assistance involves preparation for the study by helping with the development of study designs, hypotheses to be tested, objectives, endpoints, population demographics, and statistical analysis plans for protocols of studies supported by BARDA. DCS also follows the execution of the study and participates in the analyses of results.

DCS provides the following services to BARDA staff and program managers:

  • Clinical input on BARDA solicitations
  • Critical review and evaluation of technical and business proposals for BARDA solicitations
  • Guidance on clinical program development
  • Input on clinical study costs and budgets
  • Clinical support for project teams
    • Review of clinical and nonclinical protocols, investigational brochures, informed consent forms
  • Review of safety data
    • Safety monitoring procedures
    • Serious Adverse Event (SAE) reports
    • Data Safety Monitoring Board (DSMB) minutes
    • Potential safety signals (also arising outside BARDA projects)
  • Review of efficacy data
    • Early and interim data reports
    • Annual reports
    • Clinical study reports
  • Providing a clinical perspective on regulatory documents and attendance at meetings with FDA

In addition, DCS support for specific topical areas in medical countermeasure development including special populations (i.e. immunocompromised individuals), dosing strategies, pediatric populations, pre-event versus post-event administration, and influenza risk management.

Clinical Studies Network

On March 11, 2014 HHS/ASPR/BARDA established the Clinical Studies Network (CSN), a network of five clinical research organizations, to design and conduct clinical studies needed to develop medical countermeasures that help protect the American population against bioterrorism, pandemic influenza, and other public health emergencies. Establishing the CSN achieves a core recommendation cited in the 2010 Public Health Emergency Medical Countermeasure Enterprise Review (PDF-337KB).

The new Clinical Studies Network will provide a full range of clinical services required to develop, plan, conduct, monitor, and interpret data from clinical trials that test a range of interventions from small molecules and biologics to diagnostics and devices. The CSN services include conducting clinical trials in all phases (phases 1-4) of drug development from first-in-man to pivotal and post-marketing studies required by the U.S. Food and Drug Administration for the approval of a product for human use; comparing the properties of multiple products, or evaluating the potency of products stored in U.S. government stockpiles. The CSN could also be used to support BARDA-funded medical countermeasure developers in conducting clinical studies.

The CRO-based clinical network of the CSN complements the research-focused network of academic clinical sites established by NIAID, thus increasing the capacity available to the HHS. The activities of BARDA’s CSN will be coordinated with those of HHS interagency and industry partners, including the National Institute of Allergy and Infectious Diseases (NIAID), thus preventing duplication and maximizing the use of available resources. If needed, the network will supplement National Institute of Health capabilities by conducting clinical studies during public health emergencies such as a pandemic. This capability will enhance the nation’s preparedness to meet public health emergencies and terrorist threats by ensuring that clinical studies that address critical questions for emergency response and recovery can be performed in a timely manner.

BARDA awarded contracts to five U.S. companies that will make up the network. The contractors are:

Clinical Studies Network contract awardee map (PDF - 160KB)