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the ethical treatment of trial participants in 1947, following revelations of the Nazis' horrific experiments during World War II. In the United States, a series of laws and court rulings over the course of the twentieth century slowly built up the testing and quality assurance regime that exists today. It's this regime that our hypothetical treatment for a new pathogen will have to go through. Let's track how it typically works, phase by phase. Phase 1 trials. With permission from your government's regulator--in the U.S., it's the Food and Drug Administration--to run clinical trials in humans, you'll start with a small trial involving a few dozen healthy adult volunteers. You're looking to see whether the drug causes any adverse effects and to zero in on a dosage that's high enough to have the effect you want but not so high that it makes the patient sick. (Some cancer drugs are tested only on volunteers who already have the disease because they're too toxic to be given to healthy people.) Phase 2 trials. If everything goes well and you know your drug is safe, you're allowed to move on to larger trials. Here you'll give it to several hundred volunteers in the target population--people who are sick and otherwise fit the profile--and you'll look for proof that the drug does what you hope it will. Ideally, at the end of Phase 2, you know whether the drug works and perhaps the right dosage as well, because the next phase is so expensive that you only want to move ahead if you've got a good chance of success. Phase 3 trials. If all goes well up to this point, you'll run even larger trials involving hundreds of sick volunteers--half of whom get your drug candidate, the other half of whom get either the standard treatment for their condition or, if there isn't a treatment yet, a placebo. This is a lot smaller than Phase 3 trials for vaccines, which I'll explain in the next chapter. Everyone is already sick with the disease you're trying to treat, so you can see whether the drug is working