title: The role of "go no-go" decisions in TB vaccine development.
abstract: "Go no-go" decisions play a critical role in the product development plan of any TB vaccine at several points. Go no-go decisions are designed to serve the fundamental maxim in vaccine development that killing a bad vaccine project as early as possible is the hallmark of a successful overall program; in development, unlike in basic research, costs and skilled manpower requirements rise exponentially as the program proceeds. The opportunity costs in resources, manpower and equipment utilized on bad vaccine projects are unavailable to other vaccine programs. The go no-go decision is a fundamental piece of the process that balances risk, time and resources. An example of a go no-go decision development program is presented.
authors.affiliation: Aeras Global TB Vaccine Foundation, 7500 Old Georgetown Road, Bethesda, MD 20814, USA. jsadoff@aeras.org
authors.forename: Jerald C
authors.initials: JC
authors.lastname: Sadoff
authors.forename: David
authors.initials: D
authors.lastname: Hone
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics; D003659:Decision Making, Organizational; D004345:Drug Industry / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D012106:Research / Q000191:economics / Q000458:organization & administration*; D032581:Tuberculosis Vaccines
chemical_list: D032581:Tuberculosis Vaccines