Clinical Trial Phases

01

Above all else, do no harm. Click the plus sign to learn more about Phase 1 Clinical Trials

Phase 1

02

Phase 2

Safety is just the first step. Now, does it work?

Just because a drug is effective, doesn't garuntee that it will be approved. Click to find out why.

03

Phase 3

What now? Check how Phase 4 of a clinical trial works after FDA approval.

04

Phase 4

4 Phases

Clinical Trial

Phase 3 Clinical Trials

Phase 3 clinical trials compare the new therapy to the current standard of care, or what is currently being used in clinics to treat the disease. In this phase, the trial evaluates side effects and effectiveness and tries to define whether one treatment works better than the other. In many cases, people on Phase 3 clinical trials are chosen randomly to either be treated with the new therapy or with the standard of care (most cancer clinical trials do not give people a placebo, or sugar pill). The Food and Drug Administration will typically not approve a drug to be used by the general public unless it passes a Phase 3 clinical trial. Phase 3 clinical trials include more than 100 people.

Does it work better?

Phase 4 Clinical Trials

Thousands of Patients

FDA Approved

The drug is tested further in hundreds or thousand of patients.

During this phase, tested drugs are newly approved by the FDA

Long-Term Side Effects

This phase allows doctors to collect more information about the treatment over time in a large group to watch for longer-term side effects.

Phase 1 Clinical Trials

Safety First!

The goal of Phase 1 clinical trials is to test a treatment’s safety. In this phase, doctors can also learn more about how much to give a patient, what the side effects are, and how the cancer responds to the treatment. Typically, there are anywhere from 10 to 30 people in a Phase 1 clinical trial.

10-30Participants

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Phase 2 Clinical Trials

Does it work?

Phase 2 clinical trials determine whether a treatment is effective or not. Sometimes participants are separated into two or more groups. This is done to see how a new therapy compares to the standard of care or to try different amounts of the treatment. Participants in a Phase 2 clinical trial may be asked to keep logs about how they are feeling. These trials typically have fewer than 100 patients.