What are clinical
trials?
Clinical trials are research studies that involve people.
These studies test new ways to prevent, detect, diagnose, or treat diseases.
People who take part in cancer clinical trials have an opportunity to
contribute to scientists’ knowledge about cancer and to help in the development
of improved cancer treatments. They also receive state-of-the-art care from
cancer experts.
What are the types of
cancer clinical trials?
Cancer clinical trials differ according to their primary
purpose. They include the following types:
Treatment
These trials test the effectiveness of new treatments or new
ways of using current treatments in people who have cancer. The treatments
tested may include new drugs or new combinations of currently used drugs, new
surgery or radiation therapy techniques, and vaccines or other treatments that
stimulate a person’s immune system to fight cancer. Combinations of different
treatment types may also be tested in these trials.
Prevention
These trials test new interventions that may lower the risk
of developing certain types of cancer. Most cancer prevention trials involve
healthy people who have not had cancer; however, they often only include people
who have a higher than average risk of developing a specific type of cancer.
Some cancer prevention trials involve people who have had cancer in the past;
these trials test interventions that may help prevent the return (recurrence) of
the original cancer or reduce the chance of developing a new type of cancer
Screening
These trials test new ways of finding cancer early. When
cancer is found early, it may be easier to treat and there may be a better
chance of long-term survival. Cancer screening trials usually involve people
who do not have any signs or symptoms of cancer. However, participation in
these trials is often limited to people who have a higher than average risk of
developing a certain type of cancer because they have a family history of that
type of cancer or they have a history of exposure to cancer-causing substances
(e.g., cigarette smoke).
Diagnostic
These trials study new tests or procedures that may help
identify, or diagnose, cancer more accurately. Diagnostic trials usually
involve people who have some signs or symptoms of cancer.
Quality of life or
supportive care
These trials focus on the comfort and quality of life of
cancer patients and cancer survivors. New ways to decrease the number or
severity of side effects of cancer or its treatment are often studied in these
trials. How a specific type of cancer or its treatment affects a person’s
everyday life may also be studied.
What are eligibility criteria?
Every clinical trial has a protocol, or action plan, that
describes what will be done in the trial, how the trial will be conducted, and
why each part of the trial is necessary. The protocol also includes guidelines
for who can and cannot participate in the trial. These guidelines, called
eligibility criteria, describe the characteristics that all interested people
must have before they can take part in the trial. Eligibility criteria can
include age, sex, medical history, and current health status. Eligibility
criteria for cancer treatment trials often include the type and stage of
cancer, as well as the type(s) of cancer treatment already received.
Enrolling people who have similar characteristics helps
ensure that the outcome of a trial is due to the intervention being tested and
not to other factors. In this way, eligibility criteria help researchers obtain
the most accurate and meaningful results possible.
Clinical trials for
pancreatic cancer
Pancreatic cancer clinical trials are offered in many parts
of the word. These studies seek to establish the validity of new and possibly
improved treatment options.
Clinical trials are, ideally, a part of a system in which a
series of scientifically-controlled experiments shepherd a plausible medical
agent, combination of agents or procedure through a process whereby the
efficacy of the medical agent or procedure is established or not. In the U.S.
this process is overseen by the Food and Drug Administration (“FDA”).
Until more recently, when fast-tracking has become more
possible, the process of taking a potential agent from the biochemical stage
through clinical trials to final FDA approval could take as long as 15 years.
This process begins long before human testing. Generally, moving the process
into human testing is predicated on successful animal results. It is then that
the three primary phases of human testing begins. A phase I clinical trial with
human subjects seeks to answer questions about whether a drug-agent is
reasonably safe for use by humans. It also may seek to learn something of the
biokinetics of the drug. And finally tries to establish what the maximum
tolerated dose of the drug is. These are the only real aims of a phase I
clinical trial, although researchers will, of course, be looking for subtle
indications that the drug may show future promise.
Some fraction of phase I clinical trials will move on to the
phase II, which seeks to answer the question as to whether the drug has, in
fact, an apparent effect against the cancer in question (in our case pancreatic
cancer). Many potential drug therapies go no further than phase II – as they
show no real effect against pancreatic cancer. Successful phase II candidates
move on to phase III clinical trials which seek to determine how the new
therapy compares to existing standard therapies. Phase III clinical trials are
the core measure of a potential new drug. Phase III clinical trials are
controlled experiments whereby patients with similar characteristics are
assigned to receive either the existing therapy or to receive the new therapy.
After a time, the results of the arms of test are then compared. If the new
agent shows similar or improved results as compared to existing therapy, (after
another step or two) it is often approved for release by the FDA. There is even
a phase IV to this process which has to do with after-approval monitoring of
the new drug for side-effects, etc. as it makes its way into wider use.
The decision to participate in a clinical trial for
pancreatic cancer is a big one and should not be taken lightly. At its very
heart a clinical trial is an experiment. Consequently, clinical trials contain
inherent risk-both active risks and passive risks. An example of an active risk
might be encountering an unexpected side-effect of the drug. An example of a
passive risk might include the clinical trial protocol which may call for being
off all standard medical treatment for 28 days (which is not uncommon) before
beginning the clinical trial. More many diseases, this may not patter much. But
with pancreatic cancer, this kind of a rule may matter a great deal.
On the other hand, the prognosis of certain stages of
pancreatic cancer may not be great. Some of the emerging treatments may appear
to hold more promise than existing ones. Approaching the possibility of
participating in a clinical trial in a carefully reasoned, intelligent manner,
depending on circumstance, may be a smart personal decision.
There are many issues to consider. Am I a good candidate for
a clinical trial? What emerging drug or combination of drugs looks to be
promising? Is the clinical trial really (realistically) more promising than
existing therapy? Which phase of clinical trial am I comfortable participating
in? Which institution is hosting the clinical trial? What is their reputation?
What is their location relative to mine? Which physicians will be involved?
What support do I have?
And there are other issues – many of them. Probably more
than you can come up with on your own. This is when a strong bond with your
personal physician can be of great service to you. Be sure to ask for aid and
guidance from your physician (and other health professionals) in helping sort
through these kinds of complicated decisions regarding pancreatic cancer
clinical trials.
Where to find
clinical trials for pancreatic cancer?
The following sites are excellent resources for locating
clinical trials. These sites are free. Please discuss the ramifications of
participating in any clinical trial with your care provider.
Information about cancer clinical trials is available from
NCI's Cancer Information Service (CIS). CIS information specialists use
NCI’s website to identify and provide detailed information about clinical
trials that are currently accepting patients. NCI’s website contains updated
information about NCI-sponsored clinical trials and many other clinical trials
conducted by independent investigators at hospitals and medical centers in the
United States and around the world, as well as trials sponsored by
pharmaceutical companies.
2. Clinical Trials National Institutes of Health
2. Clinical Trials National Institutes of Health
A service of the U.S. National Institutes of Health provides patients, family members, health care professionals, and members of the public an easy access to information on clinical trials for a wide range of diseases and conditions, including pancreatic cancer research.
3. Center Watch
CenterWatch is one of the leading sources on the clinical
trials information for both clinical research professionals and patients:
offering news, analysis, study grants, career opportunities, and trial listings.
4. PanCan
The Pancreatic Cancer Action Network recommends that all
patients consider clinical trials when exploring treatment options. The
Pancreatic Cancer Action Network’s PALS program offers free, personalized,
confidential clinical trial searches. This service helps patients and their
families find clinical trials relevant to the patient’s diagnosis, treatment
history and geographic location.
Sources and Additional
Information:
