MTN was established to identify promising candidate microbicides and provide the necessary safety and efficacy testing in an efficient and cost effective manner to support the progression of safe, effective products to licensure. With the belief that the best clinical research program involves an open submission process for study concepts and a timeline-driven protocol development and implementation process, the MTN accepts concepts for new protocols from all interested parties.
Because the network focuses on development of new drug entities for prevention, the types of studies which are within the scope of the MTN are those that fill gaps in the development product pathway toward licensure (classic Phase 1 safety and acceptability studies, Phase 2 expanded safety studies and Phase 2B/3 effectiveness studies), bridging studies to other populations (adolescents, pregnant or lactating women, post-menopausal women), and ancillary studies which provide data on adherence, biomarkers of efficacy, or evaluation of alternative formulations. Concepts arise from a variety of sources and MTN reviews all study concepts that are submitted for consideration. Importantly, many study concepts are submitted by researchers or organizations outside of the network, most frequently by product Investigational New Drug (IND) holders based upon FDA request for safety or efficacy data. Other protocol concepts are submitted from members of the Biomedical Science Working Group (BSWG), Behavioral Research Working Group (BRWG) or Community Working Group (CWG), from site investigators, or by members of the Network Laboratory. (Click here to see our MTN Ancillary Study Form located at http://www.mtnstopshiv.org/node/4905.) Provided that the proposed study fits into the mission of MTN, the concept is routed to the Executive Committee (EC) for review, and approval is based on a tally of written ballots.
Figure 1: Source of MTN protocol concepts