What
are cancer clinical trials all about?
A cancer clinical trial is designed to answer a specific question.
For example: Can selenium supplements help prevent prostate
cancer in healthy men? Does annual screening mammography for women
ages 40 to 50 reduce breast cancer mortality? Will teaching coping
skills to cancer patients improve their quality of life?
But most cancer clinical trials are set up to study new treatments,
new combinations of treatments or new treatment regimens. Can a
promising new compound offer new hope for cancer patients? Is a
recently approved chemotherapy drug more effective if given in combination
with an older drug? Which is more effective: chemotherapy followed
by surgery, or surgery followed by chemotherapy?
How are clinical trials planned and
carried out?
Cancer clinical trials are carried out in phases:
- A phase I trial evaluates how a new drug should be given, how
often and at what dose. A phase I trial usually enrolls a small
number of patients.
- A phase II trial tests how effective a new drug or procedure
is against a particular cancer.
- A phase III trial compares a promising new drug, new combination
of drugs or new procedure with the best standard treatment. Phase
III trials typically involve large numbers of patients, usually
hundreds or thousands. A patient in a phase III trial is randomly
assigned to receive either the new treatment or the best existing
treatment.
continued on next column
|
- Phase IV trials ask new questions about standard treatments.
A phase IV trial might test how a newly approved drug works together
with other effective drugs, or with surgery and/or radiation therapy.
In a cancer clinical trial, no patient goes without treatment if
there is any known treatment that could benefit that patient. If
it becomes clear during a clinical trial that one treatment is better
than another, the trial is stopped and all patients in the trial
are offered the more effective treatment. A trial will also be stopped
early if an experimental treatment is found to be ineffective or
harmful.
How is patient safety protected?
The doctors and nurses who are in charge of a clinical trial follow
a carefully designed treatment plan known as a protocol. The protocol
spells out exactly what will be done and why, and how patients will
be protected.
At UC Davis Cancer Center, every protocol must be approved by an
Institutional Review Board made up of scientists, doctors, clergy
and other members of our community.
The IRB reviews each study for patient safeguards and scientific
merit. The IRB carefully considers whether the potential risks of
a trial are reasonable in relation to the potential benefits.
In addition, our cancer clinical trials are reviewed and monitored
by the National Cancer Institute, the Southwest Oncology Group and
other sponsoring organizations and government agencies.
Additional Resources
|
