CLINICAL TRIAL PROCESS

In order to bring a drug to the approval stage and market it to the public, it must first undergo extensive Clinical (Human) Trials. This is to ensure that the drug is safe and effective. The clinical trial process generally takes anywhere from five to 10 years, and sometimes longer.

Preclinical Research
This six-month to three-year phase involves both in vitro (test tube) and in vivo (animal) studies. During this phase the pharmacokinetic effects and safety of the drug over a wide range of doses is tested. This phase must take place before clinical trials can begin.

Phase 1
This phase, which takes approximately six months to one year, tests a small group of usually healthy volunteers in a controlled setting. Phase 1 helps to determine a drug’s side effects, its interaction with other drugs, its metabolism within the body, and the length of its action.

Phase 2
During phase 2, the drug is administered to subjects with the condition for which the drug is intended. This phase, which takes anywhere from one to two years, helps to establish the dosage recommendations and efficacy of the drug. There is often a placebo trial during this phase as well.

Phase 3
This is a longer phase, lasting approximately two to three years, in which the drug is tested on hundreds or thousands of patients in clinics and hospitals. This is also an efficacy and safety phase.

New Drug Application
After phase 3, data from the trials is compiled into a large (100,000 or more pages) document for submission to the FDA.

FDA Review and Approval
This is a one to two year process, which involves extensive review by the FDA to ensure that the drug meets the necessary standards for safety and effectiveness.

TIND (Treatment Investigational New Drug)
In cases of serious conditions, and when treatment options are minimally effective or limited, the FDA may allow a drug that has shown promise in phases 2 and 3 to be administered to larger groups of patients. During this phase, additional safety data may be collected.

Post-Marketing Surveillance and Phase 4 Studies
Also called periapproval, the sponsor must collect and report additional safety and efficacy data to the FDA during this phase. Phase 4 studies, which take place after initial approval, may be conducted to determine new uses for a drug, as well as new dosage formulations.