What Services Does this Resource Provide?
The VTEUs, supported by the Division of Microbiology and Infectious Diseases (DMID) since the 1960s, comprise a consortium of contracts with academic centers and organizations that provides a ready resource for the conduct of clinical trials to evaluate promising vaccines, treatments, and diagnostics for infectious diseases.
VTEUs conduct a broad range of studies including Phase I, Phase II, and Phase IV clinical trials of bacterial, viral, and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. VTEUs can also undertake a variety of other studies, including epidemiology studies and studies in international settings.
Who Provides the Services?
There are currently nine VTEU contract award sites.
The nine current VTEU contract award sites are:
- Baylor College of Medicine, Houston, Texas
Principal Investigator: Hana El Sahly, M.D.
- Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
Principal Investigator: David Bernstein, M.D., M.A.
- Duke University, Durham, North Carolina
Principal Investigator: Emmanuel Walter, M.D., M.P.H.
- Emory University, Atlanta, Georgia
Principal Investigator: Mark Mulligan, M.D.
- Group Health Cooperative, Seattle, Washington
Principal Investigator: Lisa Jackson, M.D., M.P.H.
- Saint Louis University, St. Louis, Missouri
Principal Investigator: Daniel Hoft, M.D., Ph.D.
- University of Iowa, Iowa City, Iowa
Principal Investigator: Patricia Winokur, M.D.
- University of Maryland, Baltimore, Maryland
Principal Investigator: Karen Kotloff, M.D.
- Vanderbilt University, Nashville, Tennessee
Principal Investigator: C. Buddy Creech, M.D., M.P.H.
Application and Review Process
Due to the high volume of requests received to conduct clinical trials in the VTEUs, DMID has developed criteria and a two-stage selection process for reviewing and determining whether to support proposed studies.
First Stage: The first stage is the preparation and submission of a study concept to DMID. Concepts may be proposed by VTEU investigators, DMID staff members, or members of the scientific community after consultation with relevant DMID staff; the early steps of this stage often involve extensive discussions between the potential collaborator and DMID. During this stage, relevant DMID staff will focus their review of the proposed concept on multiple aspects, including the evaluation factors described below. Please contact NIAIDOCRRPM@mail.nih.gov if you need assistance identifying the appropriate DMID staff contact.
Second Stage: After discussing and refining the concept with the submitter, relevant DMID staff will evaluate the proposal and determine if it meets the criteria to move forward to the second stage of the selection process. If so, the concept is then presented to the DMID concept review committee.
Evaluation Criteria: At each stage, concept proposals are evaluated on a number of factors, including, but not limited to:
- Potential public health impact:
- Provides data to support policy decisions
- Impacts development of a product/potential of the product for licensure
- Addresses a question that will advance public health
- Programmatic relevance:
- Fills gaps in the current portfolio
- Has a feasible overall product development plan
- Tests new technologies or approaches
- Is a hypothesis-generating and hypothesis-testing trial
- Leverages collaboration with external (non-DMID) resources
- Feasibility and readiness:
- Accesses readily available populations
- Utilizes a scientifically and statistically appropriate study design
- Uses available scientific data to support the planned indication/path forward
- Requires status of plans/completion of the manufacturing, pre-clinical, and other activities before the proposed trial can start
Standard User Requirements/Implementation
Users are required to enter into a Clinical Trials Agreement, as appropriate, which outlines roles, responsibilities, and expectations, including:
- DMID will sponsor the investigational new drug (IND) application for the study.
- In addition to clinical research sites, DMID will provide safety oversight, clinical monitoring, data management, and regulatory management.
- Study product will be shipped to and stored in DMID’s central repository prior to shipping to the clinical site.
- Users will complete non-clinical efforts and supply study product.
- The protocol must be approved by DMID prior to study initiation.
- All Clinical Site Principal Investigators and collaborators will retain publication rights.
- Both DMID and the User will maintain confidentiality.
For more information on the Vaccine and Treatment Evaluation Units, contact the DMID Office of Clinical Research Resources.