Clinical trials are part of clinical studies that involve using human volunteers to test specific interventions, such as drugs, devices, vaccines, or changes in diet. The participants receive these interventions according to the protocol that is developed by the investigators. The protocol provides the research coordinators with information about what is being tested, who is eligible to participate, and the schedule for how to proceed during the full length of the trials.
Clinical trials can include comparing the interventions being tested to something that is already available, to a placebo with no active ingredient, or to no intervention at all. The most important aspects being measured in these trials are the safety and efficacy of what is being tested. The new interventions need to be safe for the participants to use and need to work well enough in their favor, with the benefits outweighing the risks. Once the participants are enrolled in a trial, their progress is monitored regularly to ensure that the drug is safe and effective.
In order for the drug or any other intervention to be approved by the FDA, there are five phases that the clinical trials must go through:
Phase 0: Preliminary
Drug is given to a limited number of subjects to assess how it interacts with the human body.
Phase 1: Safety
Drug is given to a small number of healthy volunteers, with safety being the emphasis. The goal of this phase is to find any side effects and adverse events that the drug might cause.
Phase 2: Efficacy and safety
Drug is given to a larger group of people to gather preliminary data on the effectiveness of the drug in people with a certain disease or condition. Participants receiving the drug are compared to participants receiving a placebo or a different drug. Safety continues to be evaluated.
Phase 3: Final confirmation of efficacy and safety
Drug is given to an even larger group of people to confirm its effectiveness and safety before it can be approved by the FDA. The studies may include studying the drug in different populations, different dosages, or in combination with other drugs.
Phase 4: Post FDA Approval
The effectiveness and safety of the drug is evaluated after the drug is made available on the market.
Clinical trials can include comparing the interventions being tested to something that is already available, to a placebo with no active ingredient, or to no intervention at all. The most important aspects being measured in these trials are the safety and efficacy of what is being tested. The new interventions need to be safe for the participants to use and need to work well enough in their favor, with the benefits outweighing the risks. Once the participants are enrolled in a trial, their progress is monitored regularly to ensure that the drug is safe and effective.
In order for the drug or any other intervention to be approved by the FDA, there are five phases that the clinical trials must go through:
Phase 0: Preliminary
Drug is given to a limited number of subjects to assess how it interacts with the human body.
Phase 1: Safety
Drug is given to a small number of healthy volunteers, with safety being the emphasis. The goal of this phase is to find any side effects and adverse events that the drug might cause.
Phase 2: Efficacy and safety
Drug is given to a larger group of people to gather preliminary data on the effectiveness of the drug in people with a certain disease or condition. Participants receiving the drug are compared to participants receiving a placebo or a different drug. Safety continues to be evaluated.
Phase 3: Final confirmation of efficacy and safety
Drug is given to an even larger group of people to confirm its effectiveness and safety before it can be approved by the FDA. The studies may include studying the drug in different populations, different dosages, or in combination with other drugs.
Phase 4: Post FDA Approval
The effectiveness and safety of the drug is evaluated after the drug is made available on the market.
