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Clinical Trials – Overview

Clinical Trials – Overview

Clinical trials are used to test new and promising agents in the treatment of cancer. They represent the cutting edge, but the treatments they offer are unproven and may or may not be superior to other available therapies. In order to make the best treatment decision, we need to be fully informed about all our treatment options. Today’s effective standard of care was once an experimental treatment. 

Consult your physician or surgeon to see if there is a clinical trial appropriate for your particular condition.

Patients in clinical trials as a rule receive excellent care, and may be helped personally by the treatment they receive. Study patients receive up-to-date care from cancer experts– either the new treatment being tested or the best available standard treatment for their type of cancer.

There are four different phases of clinical trials. They include:

•·       Safety: A Phase 1 trial is the first step in testing a new cancer agent in humans. In these studies, researchers look for the best way to deliver the new agent. During the trial, the dose is usually increased group by group in order to find the highest dose that does not cause unacceptable harmful side effects, called toxicity. This process determines a safe and appropriate dose to use in a Phase 2 trial. Phase 1 trials usually have 15 to 30 participants.

•·       How Well It Works: Phase 2 trials begin to evaluate how well the new agent works against a specific type of cancer. The new agent is given to groups of people with one type of cancer or related cancers, using the dosage found to be safe in Phase 1 trials. Phase 2 trials usually have fewer than 100 participants. Participants usually all receive the same treatment.

•·       Comparing the new treatment to the standard: Phase 3 trials focus on learning how a new treatment compares to the accepted standard treatment. Researchers want to learn whether the new treatment is better than, the same as, or worse than the standard treatment. In Phase 3 trials, participants are randomly assigned to one of two or more groups (also called “arms”). In a study with two groups, one gets the standard treatment (control group) and the other gets the new treatment being tested (investigational group). Participants in Phase 3 studies range from people newly diagnosed with cancer to those with extensive disease. Phase 3 trials usually have hundreds or thousands of participants.

•·       Continuing Evaluation: Phase 4 trials are used to further evaluate the long-term safety and effectiveness of a treatment. Less common than phase 1, 2, and 3 trials, Phase 4 trials take place after the new treatment has been approved for standard use.

Page last updated on Apr. 22, 2009