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Clinical trials are research studies conducted
with the hopes of determining safer and more effective means to treat
serious illnesses. They are designed with specific objectives in mind,
ranging from finding better ways to prevent disease to discovering
new means to diagnose and treat disease. There are four main types
of clinical trials:
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Treatment Trials:
Study the safety and efficacy of a new
treatment. |
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Prevention
Trials: Study new approaches in preventing
diseases. |
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Screening Trials:
Study approaches to detecting diseases |
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Quality of
Life Trials: Study ways to improve the quality of life
and comfort for patients.
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Trial Phases
Before the U.S. Food and Drug Administration
(FDA) can approve a new treatment for human use, it must undergo
extensive testing to determine its safety and efficacy in treating
a specific disease. Drug development involves three stages of
human clinical testing: Phase 1, Phase 2, and Phase 3. Human
clinical trials typically follow years of preclinical development
in laboratories and animal studies. |
Preclinical Study: Initial
study conducted to determine potential new treatments for specific
disease indications. Animal models are frequently used to help determine
a treatment's safety prior to introducing it to humans.
Phase 1 Trial: Clinical
trial conducted to evaluate the safety of a drug or therapy. How a
drug should be administered (e.g. oral, injection) and dose levels
are also evaluated. Phase 1 trials typically involve a small group
ranging from 5 to 50 patients, depending on the disease indication.
Phase 2 Trial: Clinical trial
conducted to further evaluate the safety of a drug or therapy and
to evaluate its efficacy. In addition, researchers focus on determining
optimal dose levels. Phase 2 trials typically involve a larger group
than Phase 1 trials, approximately 15 to 200 patients, depending on
the disease indication.
Phase 3 Trial: Clinical
trial conducted to confirm the efficacy of a new drug or therapy.
Trial participants are usually included in one of two study groups:
one which will receive the new drug being evaluated, and one that
receives the already approved, current standard of treatment. Phase
3 trials can enroll anywhere from 50 to 5,000 patients.
During Phase 3 trials, study sponsors will begin to assemble an application
[either a Biologics License Application (BLA) or a New Drug Application
(NDA)] for submission to the FDA demonstrating the investigational
drug or therapy's safety and efficacy based on the data gathered from
the clinical trials. The FDA will evaluate the submission and make
a determination as to the approvability of the application. Drugs
and therapies that are approved by the FDA can then be commercially
marketed throughout the United States.
Note: While patient numbers in clinical trials may vary greatly
depending upon trial design or disease indication, these numbers provide
average ranges of trial sizes for the abovementioned trial phases
How to Become Involved in a Clinical Trial
There are numerous resources on the Internet that list clinical trials
being conducted in multiple disease indications. The following is
a list of some of the websites that focus primarily on cancer clinical
trials:
www.Cancer411.org
www.Centerwatch.com
www.clinicaltrials.gov
www.cancer.gov
Note: Cell Genesys does not endorse
the information included in the above websites.
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