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What are Clinical Trials?
Clinical trials are research studies in which people help doctors and scientists find ways to improve health and diseases care, and find new treatments and cures for illnesses and diseases. Each clinical trial tries to answer scientific questions and to find better ways to prevent, diagnose, or treat a disease.
A clinical trial is one of the final stages of a long and careful pharmaceutical research process. Studies are done with patients to find out whether promising approaches to disease prevention, diagnosis, and treatment are safe as well as effective at doing what the treatment is intended to do.
Clinical research involves the testing of a new drug progresses in an orderly series of steps, called phases. Each phase corresponds to a step in the development of the drug or treatment to being available to the marketplace and people that need it. The ordering of these phases depends on what is the studies outcome and how many patients are involved in the trial.
Different Phases
- Phase 1: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrols only a small number persons and most often only healthy volunteers.
- Phase 2: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works on the targeted disease.
- Phase 3: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard and often also a dummy pill (placebo). A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enrol large numbers of people and may be conducted at many doctors' offices, clinics, and hospitals in several countries.
- Phase 4: After the drug reach the market, phase 4 studies aim at evaluating the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are usually involved in a phase IV trial.
