Phase I Clinical Trial Units for Therapeutics

The Phase I Clinical Trial Units for Therapeutics support the design, development, implementation, and conduct of Phase I clinical trials to assess safety, pharmacokinetics, and/or pharmacodynamics of licensed and investigational therapeutic products, including immunomodulatory agents and monoclonal antibodies, against viral (other than HIV), bacterial, parasitic, and fungal pathogens, including NIAID priority bio-defense pathogens and emerging and re-emerging infectious diseases.

Main Areas of Focus

  • Viral (other than HIV), bacterial, and fungal pathogens, including NIAID priority bio-defense pathogens
  • Emerging and re-emerging infectious diseases

Support Services

  • Phase I clinical trail support including design, development, implementation, and conduct of trials
  • Assessment of safety, pharmacokinetics, and/or pharmacodynamics of licensed and investigational therapeutic 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.

Evaluation Criteria

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
    • Requires status of plans/completion of the manufacturing, pre-clinical, and other activities before the proposed trial can start

How To Get Started

Due to the high volume of requests received to conduct clinical trials in the Phase I Clinical Trial Units, 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 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.

Assurance to Requestors

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.

Location

  • Clinical Research Management
  • Duke University
  • DynPort Vaccine Company
Content last reviewed on November 17, 2017