How to Propose a Protocol Concept
The Microbicide Trials Network (MTN) was established with the goal of developing safe and effective microbicides for HIV prevention using a drug development paradigm. As such, all MTN studies are designed to collect the kind of data regulatory agencies require for determining whether or not to approve a given product. Because the effectiveness of a product is also dependent on its use, behavioral and social science is an important focus of MTN’s portfolio of studies.
The types of studies that are within the scope of the network’s mission are those that fill gaps in the development of products to licensure. These include classic Phase 1 safety and acceptability studies, Phase 2 expanded safety trials and Phase 2B/3 effectiveness trials; bridging studies to other populations (such as adolescents, pregnant or breastfeeding women or post-menopausal women); and ancillary studies that provide data on adherence, biomarkers of efficacy, or evaluation of alternative formulations.
The MTN accepts concepts for new protocols from all interested parties in the belief that the best clinical research program is one that is both enabling and receptive to new ideas and capable of maintaining a timeline-driven protocol development and implementation process. 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 developers who hold the Investigational New Drug (IND) and are seeking to collect specific safety or efficacy data that has been requested by the U.S. Food and Drug Administration (FDA). Protocol concepts may also be submitted by members of MTN’s Biomedical Science Working Group (BSWG), Behavioral Research Working Group (BRWG) or Community Working Group (CWG); an MTN investigator, including those affiliated with clinical research sites.
Provided that the proposed study fits into the mission of MTN, the concept will be routed to the Executive Committee (EC) for review, and approval will be based on a tally of written ballots.
If you have a concept you would like to submit for consideration by the MTN, or have questions about the process, please contact Principal Investigator Sharon Hillier.
Looking instead to propose an Ancillary Study?