Salvage Trials: What the Clinician Wants
Reasonable expectation of efficacy (new agents, or comparison of regimens with existing regimens)
Salvage trials for new agents available before target population experienced (expanded access)
Entry criteria for the populations at need
Flexible criteria for “success”, but bail out for lack of effect
Placebo controls acceptable if efficacy of agent truly unknown
Inclusion of non-drug interventions (STI’s, immune stimulants, etc.)