The National Institute of Allergy and Infectious Diseases has issued a Request for Proposals (RFP) to support a Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases.
Since Phase I studies are often on the critical path for product development, the ability to prepare protocols and execute trials in a timely manner is important. To help meet these goals and move promising candidates into the clinical pipeline in a timely manner, NIAID awarded contracts for the Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases (Phase I Unit) in 2008.
The current RFP is to recompete the Phase I Unit research program requirements to continue to provide DMID with the infrastructure necessary for the design and conduct of Phase I clinical trials for therapeutics.
The scope of activities to be performed by the Contractor will encompass all aspects of the design, development, implementation, and conduct of Phase I clinical trials to assess safety, pharmacokinetics and pharmacodynamics of licensed and investigational therapeutic products. The types of trials conducted, or planned, include first-in-human small molecule and monoclonal antibody trials, corrected QT interval (QTc) trials, and drug-drug interaction trials.
The evaluation of new and improved vaccine and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase I, Phase II, Phase III, and Phase IV clinical trials for preventive and therapeutic measures against infectious diseases.
Further details are available under Solicitation Number: RFP-NIAID-DMID-NIHAI2013178.