In an effort to improve preparedness, the U.S. federal government is seeking to bolster Clinical Studies Network service capabilities for advanced clinical development of medical countermeasures to treat the adverse health effects resulting from exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemic influenza and emerging infectious diseases.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary of Preparedness and Response (ASPR), Department of Health and Human Services (HHS), oversees the national effort to develop such countermeasures.
BARDA’s Clinical Studies Network (CSN) conducts Phase I, II, III, and IV trials and provides other services for the development of vaccines and therapeutics. The results of these trials form part of the basis for advancing investigational products through development with the ultimate goal of submission to the FDA.
Lessons Learned
The Clinical Studies Network (CSN) was established as a Core Service in 2012 when BARDA awarded Indefinite Delivery/ Indefinite Quantity (IDIQ) contracts to five full service Contract Research Organizations (CROs) in 2013 to form the CSN infrastructure.
During the five years of the CSN’s existence, several important capability gaps were identified:
- Lack of long-term storage capacity for records, investigational products, and biological specimens
- Need for a data coordination center
- Need to engage different CROs to provide services on a routine basis without urgent timelines
- Need for services during a public health emergency (PHE) when rapid timelines are crucial
Anticipated Requirements
BARDA will seek to address these issues should any future CSN solicitation be released, by including the following enhancements:
- Diversification of the pool of contractors to include CROs in the CSN that can provide routine services or response services as primary contractors for the planning and execution of clinical studies. Services would include project management, study start up, site training and support, site feasibility and selection, site monitoring and management, specimen and IP management, laboratory services, regulatory services, Institutional Review Board services and quality assurance, as well as other services.
- Engaging a statistical service & data coordination center to standardize data collection, management, and analysis across CSN studies. Services would include study design, an interactive web response system, data management, safety monitoring (Safety Monitoring Committee or Data and Safety Monitoring Board), medical monitoring and other data analysis and reporting services. This CRO would also provide a centralized clinical study records (i.e., Trial Master File) archive for indefinite long-term storage that meets regulatory requirements. The capability of providing innovative trial design and rapid trial start-up would be of critical significance to meet the challenges of developing MCM for emerging public health threats. Additionally, access to data mining capabilities via health care utilization databases would be advantageous.
- Employing a single facility for long-term storage of clinical study specimens (possibly non-clinical specimens) and investigational products across BARDA-supported studies. Services may extend to managing transport of clinical study specimen and IP on studies, laboratory services, end-of-study archiving, and managing future use of specimens (retrieving, aliquoting, labelling, shipping, tracking, etc.).
Current Status
BARDA is currently compiling market research and industry input on pros and cons of the proposed structure and possibilities for contract configuration. One proposed contracting strategy is to award a Single Award IDIQ contract for storage of specimens and IP, and a Single Award IDIQ Contract for statistical services and data coordination. There would be several Multiple Award IDIQ Contracts for clinical trial planning and execution for regular services. Multiple Award Contracts would be awarded to a small number of sources demonstrating capabilities for rapid response to public health emergencies. The main contracting mechanism for each of the three CSN parts will likely be an IDIQ fee-for-service-model.
BARDA has not made a commitment to procure any items or services at this time. Any future announcements for this effort will be made on FedBizOpps.com.
