The plan is submitted to FDA with information on animal testing data, the composition of the drug, manufacturing data, qualifications of its study investigators, and assurances for the protection of the rights and safety of the people who will participate in the trial. The entire drug development process is lengthy and expensive. On average it takes about 10 years to complete. But it is an effective system that generally protects the public from dangerous and ineffective drugs. The studies help determine appropriate doses for further investigations.
Trials usually involve a small number of volunteers.
This phase continues to evaluate the safety profile of the drug and identifies the most common side effects. This phase usually involves a few hundred people. According to FDA, almost 80 percent of all drugs tested are abandoned by their sponsors after either the first or second phase because of drug toxicity or ineffectiveness. This stage compares standard treatments with new ones. The trials, which primarily aim to obtain the necessary effectiveness data, may examine additional uses for a drug and consider additional population subsets.