What is a Clinical Trial?
Once a proposed treatment or medicine is found to be helpful and safe in test tubes and in animals, it must also prove safe and effective in humans. This evaluation period is known as a clinical trial. Clinical trials, also called research studies or protocols, help doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses.
Types of Drug Studies
There are four types of studies:
- Phase 1 studies test a potential new drug with a small number of volunteers for best dosage and potential side effects.
- Phase 2 studies test a drug with known dose and side effects with a larger number of volunteers to learn more about side effects, how the body uses the drug and how the drug helps the condition.
- Phase 3 and 4 studies compare the new drug with a commonly used drug.
NIH and FDA guidelines
The researchers and physicians conducting a clinical trial are bound by strict rules. These rules are designed, monitored and enforced by the NIH and FDA. Any breach of these rules could result in serious consequences for the researchers. Needless to say, researchers are careful to follow the approved protocol.
The decision to volunteer in a clinical trial is a very personal one. However, there are guidelines to protect study participants. Testing in humans is permitted only in volunteers who have been briefed about the purpose of the study as well as the potential benefits and hazards of trial participation. This is called informed consent. It is the responsibility of the trial’s medical team to explain the risks to potential study participants.
The informed consent form has detailed information about the study, including the length of the study, the number of visits required, medical procedures, and medications included. It also provides expected outcomes, potential benefits and possible risks.
Volunteers may leave a study at any time.