Learn About Cancer Clinical Trials
What Is a Cancer Clinical Trial?
A cancer clinical trial is a medical research study in which people
participate as volunteers to test new methods of prevention, screening,
diagnosis, or treatment of a disease. A cancer clinical trial can also be referred to
as a cancer clinical study.
Some cancer patients may fear that enrolling in a cancer trial means
they chance receiving no cancer treatment at all, but the reality is that patients in
clinical trials receive either the best cancer treatment currently known for their
cancer, or a new, and possibly more effective, therapy.
To learn more about cancer clinical trials and to get your questions answered,
click on the links below.
Where do cancer clinical trials take place?
Cancer clinical trials are
conducted in doctors’ offices, cancer centers, other medical centers, community
hospitals and clinics, and veterans’ and military hospitals in cities and towns
across the United States and around the world. Cancer clinical trials may include
participants at one or two highly specialized centers or they may involve
hundreds of locations at the same time.
What are the phases of a cancer clinical trial?
Cancer clinical trials
are usually conducted in a series of steps, called “phases.” Each clinical trial phase is
designed to answer a separate research question. Phase I trials evaluate
safety, Phase II trials measure effectiveness, and Phase III trials test
against best existing cancer treatment. Phase IV trials are conducted to further
evaluate new uses or long-term effects of the treatment.
What is a randomized cancer clinical trial?
A randomized cancer clinical
trial is a study in which the participants are assigned by chance to separate
groups to compare different cancer treatments; neither the researchers nor the
participants choose which group the patient is entered into. People are
assigned by chance to either a standard treatment group (control group) or
investigational treatment arm. In cancer clinical trials the control group
invariably receives the standard treatment currently available.
Why are “randomized trials” important in developing new treatments for
Randomization in a
cancer clinical trial gives each cancer patient an equal chance of being assigned to
any of the groups. It is one method used to prevent bias in cancer research.
What is standard therapy?
In medicine, standard
therapy is a cancer treatment that experts agree is appropriate, accepted, and widely
used. Healthcare providers are obligated to provide patients with standard
therapy. The terms standard of care or best practice are also used.
What is an investigational drug?
A drug is considered to
be investigational if it is being tested in people, but has not yet been
approved for marketing by the US Food and Drug Administration (FDA) by proving
to be both safe and effective for the diagnosis, prevention, or treatment of a
defined disease or condition. A drug may be approved by the FDA for use in one
disease or condition, but be considered investigational in other uses.
What is the difference between "standard therapy" and "experimental therapy"
in a cancer clinical trial?
In medicine, standard
therapy is the treatment that experts agree is appropriate, accepted, and
widely used. Healthcare providers are obligated to provide patients with
standard therapy. Standard therapy is also called standard of care or best
practice. In cancer clinical trials, experimental therapy refers to a drug (including
a new drug, new dose, combination with other drugs, or route of administration)
or procedure that has undergone basic laboratory testing and received approval
from the FDA to be tested in human subjects. A drug or procedure may be
approved by the FDA for use in one disease or condition, but may be considered
experimental in other diseases or conditions. Experimental therapy is also
called investigational therapy.
A placebo is an inactive
substance or treatment that looks the same as, and is given the same way as, an
active drug or treatment being tested. The effects of the active drug or
treatment are compared to the effects of the placebo. The use of placebos in
cancer treatment studies is very uncommon and only with patient consent.
Generally, in cancer trials “standard therapy” is given in place of a placebo.
If I enter a cancer clinical trial is there a chance I will receive a
“placebo” (eg, sugar pill) instead of a therapy that could treat my cancer?
This misunderstanding is
why some cancer patients are reluctant to enter cancer clinical trials. Placebos (also called sugar
pills) are rarely used in cancer clinical trials and are never used in place of
treatment. Patients who join cancer clinical trials are either given the
standard of care, (best treatment available for their specific cancer) or
receive a new treatment being investigated. Remember that although you are the
only one who can decide whether to take part in a cancer clinical trial, your doctor
and the rest of the healthcare team are important and valuable sources of
balanced information about the risks and benefits of participation.
How would my cancer clinical trial “experience” compare with my “standard of care”
An important benefit to
participating in a cancer clinical trial is the high level of patient care, as
patients in cancer clinical trials are followed more closely by their doctors
and nurses. This monitoring is an integral part of the cancer clinical trial process,
and undoubtedly provides cancer patients with a high quality experience, whether they
are in the treatment or control group.
Are cancer survivors satisfied with their cancer clinical trial experience?
Yes, very. Survivors who participated
in a study conducted by the Coalition reported they were very satisfied with
the cancer clinical trial experience, with 91% indicating they would recommend
participating in a trial to a friend. Additional study results showed:
97% felt they were fully informed on risks and benefits
96% felt they were treated with dignity and respect
92% had a positive experience
The majority of cancer patients
(more than 90%) rejected the idea that participants felt like a guinea pig or
that they were subjected to more tests and procedures than were necessary.
Are cancer clinical trials just for advanced cancer?
No, although this is a
common misconception. Cancer clinical trials exist for all types and stages of
cancer, as well as for cancer prevention.
Are there cancer clinical trials for people who do not have cancer, but who are at
a higher risk of the disease due to their family history?
Yes, there are cancer clinical
trials for those at higher risk of the disease due to their family history.
These are called cancer prevention trials. Prevention trials study ways to
reduce the risk, or chance, of developing cancer. Most prevention trials are
conducted with healthy people who have not had cancer. Some trials are
conducted with people who have had cancer and want to prevent the return of
cancer or reduce the chance of developing a new type of cancer.