Early Phase Clinical Trial Units (EPCTU)

Implement Phase 0 to Phase II clinical trials, including proof-of-concept studies in healthy and diseased human populations-domestically and internationally-in an expeditious and efficient manner, aided by bioanalysis when necessary. In the event of urgent public health need, Phase III studies may be conducted. The candidate products to be evaluated under the Early Phase Clinical Trial Units (EPCTU) IDIQ contracts could include new or tested investigational products, such as small molecules; monoclonal antibodies; immunoglobulins; convalescent plasma; passive transfer studies; vaccines; adjuvants; and other immunomodulatory products against infectious diseases, arising within DMID's preclinical and early product development programs, as well as those arising from other research partners outside of DMID.