The Early Phase Clinical Trial Units (EPCTUs) support the design, development, implementation, and conduct of Phase 0 to Phase 2 clinical trials, including proof-of-concept studies in healthy, special, and disease-specific populations, carried out in an expeditious and efficient manner, aided by bioanalysis when necessary, against viral, bacterial, parasitic, and fungal pathogens and emerging and re-emerging infectious diseases. The candidate products assessed through the EPCTUs may include licensed or investigational products such as small molecules, monoclonal antibodies, immunoglobulins, convalescent plasma, passive transfer studies, vaccines, adjuvants, diagnostics, and novel immunomodulatory products against infectious diseases. The EPCTUs evaluate candidate products from the preclinical and early product development programs of NIAID’s Division of Microbiology and Infectious Diseases (DMID), as well as from external research partners.
Main Areas of Focus
- Viral, bacterial, parasitic and fungal pathogens
- Emerging and re-emerging infectious diseases
- Clinical trial support including design, development, implementation, and conduct of Phase 0-Phase 1 studies in healthy subjects; Phase 1 studies in special populations (e.g., children, pregnant women, or older adults); and Phase 2 condition-specific studies (e.g., renal, hepatic, or cardiac impairment). In the event of an urgent public health need, Phase 3 studies may be considered.
- Bioanalysis of specimens
- Assessment of safety, immunogenicity, therapeutic dose-finding, pharmacokinetics, and/or pharmacodynamics of licensed and investigational products
Who Can Use This Resource
Concepts may be proposed by DMID staff members, or members of the scientific community after consultation with relevant DMID staff.
Each proposal is judged against 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
- Meets requirement of the completion of all pre-clinical, manufacturing, and other activities before the proposed trial can start
Assurance to Requestors
Collaborators 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(s).
- Collaborators will complete non-clinical efforts and supply study product.
- The protocol must be approved by DMID prior to study initiation.
- DMID will retain ownership of clinical trial biospecimens and will transfer biospecimens to collaborators as needed for per protocol testing
- All clinical site Principal Investigators and collaborators will retain publication rights.
- Both DMID and the collaborator will maintain confidentiality.
- ICON Government and Public Health Solutions, Inc
- Duke University
- DynPort Vaccine Company (DVC)
- PPD Government and Public Health Services