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Phases of a Clinical Trial Surgery

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Clinical Trials in Melanoma

Benefits of Par cipa ng in a

Clinical Trial

Phases of a Clinical Trial

Ques ons to Ask When

Deciding to Enter a Clinical
Trial

Phase 1: Looking at Safety

Once laboratory studies show that a new approach has promise, a Phase 1 trial
can begin. A Phase 1 trial is the first step in tes ng a new cancer agent in
humans. In these studies, researchers look for the best way to give people the
new agent (for example, by pill or by injec on), how o en it should be given,
and what the safest dose is. These studies also include special laboratory tests
such as blood tests and biopsies to evaluate how the new agent is working in
the body. Phase 1 cancer trials involve small groups of people with cancer.

Phase 2: How Well the New Treatment Works

 Phase 2 trials con nue to test the safety of the new agent and begin to evaluate
how well it works against a specific type of cancer. In these trials, the new agent
is given to groups of people with a certain type of cancer or related cancers,
using the dosage found to be safe in Phase 1 trials. Phase 2 cancer trials usually
have less than 100 par cipants.

Phase 3: Comparing a New Treatment to the Standard Treatment

Phase 3 trials focus on learning how a new treatment compares with standard,
or the most widely accepted, treatment. Researchers want to learn whether the
new treatment is be er than, the same as, or worse than the standard
treatment.

In Phase 3 trials, par cipants have an equal chance to be assigned to one of two
or more groups (also called “arms”). The process of assigning par cipants to
groups is called randomiza on.

In a study with two groups:

group 1 gets the standard treatment (control group)

group 2 gets the new treatment being tested (inves ga onal group)

Phase 4: Continuing Evaluation

Phase 4 trials are used to further evaluate the long-term safety and
effec veness of a treatment. Less common than Phase 1, 2, and 3 trials, Phase 4
trials take place a er the new treatment has been approved for standard use.

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Benefits of Par cipa ng in a Clinical Trial
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It is important to use the me with your doctor to learn about clinical trials and
whether there is one right for you. Find ques ons you may want to ask him/her.

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