Clinical Trial Information
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Research |
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What is a Clinical Trial?
Clinical trials are research studies in which
people help doctors find ways to improve health and cancer care. Each study
tries to answer scientific questions and to find better ways to prevent,
diagnose, or treat cancer.
Why are there clinical trials?
A clinical trial is one of the final stages
of a long and careful cancer research process. Studies are done with cancer
patients to find out whether promising approaches to cancer prevention,
diagnosis, and treatment are safe and effective.
What are the different types of clinical
trials?
Treatment Trials test new treatments (like a new cancer drug, new approaches to surgery
or radiation therapy, new combinations of treatments, or new methods such
as gene therapy).
Prevention Trials test new approaches, such as medicines, vitamins, minerals or other supplements
that doctors believe may lower the risk of a certain type of cancer. These
trials look for the best way to prevent cancer in people who have never
had cancer or to prevent cancer from coming back or a new cancer occurring
in people who have already had cancer.
Screening Trials test the best way to find cancer, especially in its early stages.
Quality of Life Trials (also called Supportive Care trials) explore ways to improve comfort and
quality of life for cancer patients.
What are the phases of clinical trials?
Most clinical research that involves the
testing of a new drug progresses in an orderly series of steps, called phases.
This allows researchers to ask and answer questions in a way that results
in reliable information about the drug and protects the patients. Clinical
trials are usually classified into one of three phases:
Phase I trials: These first studies in people evaluate how a new drug should be given
(by mouth, injected into the blood, or injected into the muscle), how
often, and what dose is safe. A Phase I trial usually enrolls only a small
number of patients, sometimes as few as a dozen.
Phase II trials: A phase II trial continues to test the safety of the drug, and begins
to evaluate how well the new drug works. Phase II studies usually focus
on a particular type of cancer.
Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical
procedure in comparison to the current standard. A participant will usually
be assigned to the standard group or the new group at random (called randomization).
Phase III trials often enroll large number of people and may be conducted
at many doctors' offices, clinics, and cancer centers nationwide.
Who is eligible to participate in a clinical
trial?
Each study has its own guidelines for who
can participate, called eligibility criteria.
Generally, participants in a study are alike in key way, such as the type
and stage of cancer, age, gender, or previous treatments. The eligibility
criteria are included in the study plan. To find out if you are eligible
for a particular study, talk to your doctor or nurse in charge of enrolling
patients in the study.
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