Home: Publications: Forum Archives: MFF Forum, edition 5
Clinical
Trials: Why are They Important?
by Stuart Lessin, M.D., Fox Chase Cancer Center
A clinical trial
is a carefully designed study to test the effectiveness of a new
drug or disease treatment. Clinical trials are designed to answer
three basic questions about a new treatment:
1) is it safe?
2) Does it work?
3) Does it work better than other treatments?
Usually, three separate
clinical trials are designed to answer these basic questions.
A phase I clinical trial tests new agents that are administered
to humans for the first time. The main objective of a phase I
trial is to test for safety,
that is, what types of side effects do patients experience and what is the
safest dose. For new cancer treatments, phase I trials recruit
patients with advanced
stages that have not been successfully treated with other therpies.
Phase
II clinical trials test how well a new treatment works, at doses
determined from the phase I study. Depending on the nature of the
new treatment and
the cancer being studied, phase II trials may include one or more stages
of cancer
patients.
Phase III clinical trials
compare a new treatment with other established treatments, to determine
if the new treatment produces better responses
rates. To gain
Food and Drug Administration approval, a new cancer treatment must complete
all three
phases and clearly demonstrate that it is safe (with tolerable side effects)
and effective in treating a particular cancer.
The design of a clinical
trial, referred to as a protocol, is thoroughly reviewed by one
or more panel of experts. An internal review board (IRB),
a committee
of health care providers, scientists and lay persons carefully review
all human safety and ethical issues and must provide the final approval,
before
a clinical
trial can begin. A clinical trial is continuously monitored and reviewed
annually by the IRB to ensure that it is conducted properly and that
the tested treatments
are safe.
Where to find more
information:
NCI's Cancer Information
Service (CIS): The
CIS provides toll-free access to trained cancer information specialists
at 1-800-4-CANCER.
Additional information is available at http://www.cancer.gov/cancerinfo/.
NCI's Clinical Trials
Website:
This website enables visitors to search for clinical trial results,
developments, ongoing clinical
trials,
general clinical trial information, and more. http://www.cancer.gov/clinicaltrials
ClinicalTrials.gov: The
U.S. National Institutes of Health, through its National Library
of Medicine, has developed ClinicalTrials.gov
to provide patients, family members and members of the public
current information about clinical research studies. This website
contains
information on cancer and other conditions. www.clinicaltrials.gov
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