A clinical trial is a research study used to evaluate the
safety and effectiveness of new treatments.
When cancer patients have exhausted all established therapies, they
often try to find a relevant clinical trial.
Clinical trials are divided into four phases, Phase I, Phase II, Phase III and Phase IV.
Usually one starts hearing about a new "wonder drug" toward the end of its phase II trials. However, one should not reach conclusions based on phase II trials, as promising results have a tendency to evaporate once the therapy is submitted to the rigor of a phase III trial.
In essence, a phase II trial demonstrates whether a new drug shows promise and identifies the appropriate treatment level, and a phase III trial confirms whether or not that promise is real. Until the phase III trial is complete, the new drug should be considered experimental.
One should not pursue the therapy being tested in a clinical trial unless one is participating in the trial and fully understands the risks. There is a great tendency to want to try a therapy that fared well in a phase II trial. But until that therapy has completed phase III trials, it is unproven.
Copyright © 2005-2009 by Mark Kantrowitz. All rights reserved.
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