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.
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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.
Evaluation Criteria: At each stage, concept proposals are evaluated on a number of factors, including, but not limited to:
Last Updated April 11, 2016