About clinical trials
What is a clinical trial?
What are the types of clinical trials?
What are the phases of clinical trials?
Learn more about clinical trials
Key questions to ask your doctor
Find a clinical trial
a cancer patient, you may take part in a clinical trial. The more you know
about clinical trials, the better informed you will be when deciding whether or
not to participate. In this
section, you will find general information about clinical trials that is meant
to supplement what your doctors communicate to you. In addition, we also provide a link to the listing
of studies being conducted at the Chao Family Comprehensive Cancer Center.
What is a
cancer clinical trial is a medical research study in which people participate
as volunteers to test a new medical approach to determine whether it is safe
and effective. Some clinical trials study a drug, a medical device, or a new
way of doing surgery. Others test new ways to prevent disease, diagnose cancer,
improve quality of life, or help people with cancer manage difficult
psychological and social issues.
a therapeutic clinical trial, patients receive either the standard of care – treatment
that doctors agree is appropriate, accepted and widely used - or a new drug,
procedure, or device which is being studied.
By participating in a clinical trial, patients have access to
leading-edge treatments and therapies long before they are available to the general
a trial, more and more information is gained about a new treatment, its risks,
and how well it may or may not work. In
addition, patients who take part in cancer clinical trials have an opportunity
to help scientists learn more about cancer – how it grows, how it acts, and
what influences its growth and spread. Many
of the approaches that doctors use to treat cancer today would never have
become available without clinical trials.
What are the types of Clinical Trials?
Cancer clinical trials differ according to their
primary purpose. They include the following types:
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.
These trials test new interventions (medicines, vitamins, minerals, or other supplements)
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
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
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 cance
- 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
In addition to answering questions about the effectiveness of
new interventions, clinical trials provide the opportunity for additional studies. These additional research studies, called
correlative or ancillary studies,
may use blood, tumor, or other tissue specimens (also known as “biospecimens”)
obtained from trial participants before, during, or after treatment. For
example, the molecular characteristics of tumor specimens collected during a
trial might be analyzed to see if there is a relationship between the presence
of a certain gene mutation or the amount of a specific protein and how trial
participants responded to the treatment they received. Information obtained
from these types of studies could lead to more accurate predictions about how
individual patients will respond to certain cancer treatments, improved ways of
finding cancer earlier, new methods of identifying people who have an increased
risk of cancer, and new approaches to try to prevent cancer.
trial participants must give their permission before biospecimens obtained from
them can be used for research purposes.
What Are the
Phases of Clinical Trials?
interventions are often studied in a stepwise fashion, with each step
representing a different “phase” in the clinical research process. These are
highly regulated activities that allow researchers to pose questions that
result in reliable information about the drug and protect patients. The
following phases are used for cancer treatment trials:
0 Clinical Trials
trials represent the earliest step in testing new treatments in humans. In a
phase 0 trial, a very small dose of a chemical or biologic agent is given to a
small number of people (approximately 10-15) to gather preliminary information
about how the agent is processed by the body (pharmacokinetics) and how the
agent affects the body (pharmacodynamics). Because the agents are given in such
small amounts, no information is obtained about their safety or effectiveness
in treating cancer. Phase 0 trials are also called micro-dosing studies,
exploratory Investigational New Drug (IND) trials, or early phase I trials. The
people who take part in these trials usually have advanced disease, and no
known, effective treatment options are available to them.
I Clinical Trials
trials are conducted mainly to evaluate the safety of chemical or biologic
agents or other types of interventions (e.g., a new radiation therapy technique).
They help determine the maximum dose that can be given safely (also known as
the maximum tolerated dose) and whether an intervention causes harmful side
effects. Phase I trials enroll small numbers of people (20 or more) who have
advanced cancer that cannot be treated effectively with standard (usual)
treatments or for which no standard treatment exists. Although evaluating the
effectiveness of interventions is not a primary goal of these trials, doctors
do look for evidence that the interventions might be useful as treatments.
II Clinical Trials
trials test the effectiveness of interventions in people who have a specific
type of cancer or related cancers. They also continue to look at the safety of
interventions. Phase II trials usually enroll fewer than 100 people but may
include as many as 300. The people who participate in phase II trials may or
may not have been treated previously with standard therapy for their type of
cancer. If a person has been treated previously, their eligibility to
participate in a specific trial may depend on the type and amount of prior
treatment they received. Although phase II trials can give some indication of
whether or not an intervention works, they are almost never designed to show
whether an intervention is better than standard therapy.
III Clinical Trials
trials compare the effectiveness of a new intervention, or new use of an
existing intervention, with the current standard of care (usual treatment) for
a particular type of cancer. Phase III trials also examine how the side effects
of the new intervention compare with those of the usual treatment. If the new
intervention is more effective than the usual treatment and/or is easier to
tolerate, it may become the new standard of care.
III trials usually involve large groups of people (100 to several thousand),
who are randomly assigned to one of two treatment groups, or “trial arms”: 1) a
control group, in which everyone in the group receives usual treatment for
their type of cancer, or 2) an investigational or experimental group, in which
everyone in the group receives the new intervention or new use of an existing
intervention. The trial participants are assigned to their individual groups by
random assignment, or randomization. Randomization helps ensure that the groups
have similar characteristics. This balance is necessary so the researchers can
have confidence that any differences they observe in how the two groups respond
to the treatments they receive are due to the treatments and not to other
differences between the groups.
is usually done by a computer program to ensure that human choices do not
influence the assignment to groups. The trial participants cannot request to be
in a particular group, and the researchers cannot influence how people are
assigned to the groups. Usually, neither the participants nor their doctors
know what treatment the participants are receiving.
who participate in phase III trials may or may not have been treated
previously. If they have been treated previously, their eligibility to
participate in a specific trial may depend on the type and the amount of prior
treatment they received.
most cases, an intervention will move into phase III testing only after it has
shown promise in phase I and phase II trials.
IV Clinical Trials
trials study a treatment after the FDA has approved it. Phase IV trials evaluate the side effects,
risks, and benefits of a drug or other therapy over a long period of time and
in a larger number of people than in phase III trials. Thousands of people are involved in a phase
IV trial, and randomization is generally not used.
Learn More about
hope this guide will help you understand some of the basics of clinical trials.
you have any questions about clinical trials or trials offered at the Chao
Family Comprehensive Cancer Center, please contact our Clinical Research Office
Toll free: 877.UC.STUDY
the National Cancer Institute (NCI) has an expansive website of information. NCI - Clinical Trials
Key Questions to
Ask Your Doctor
considering a clinical trial should feel free to ask any questions or bring up
any issues concerning the trial at any time. NCI has some suggestions of
questions to ask your doctor that may give you various ideas as you think about
your own questions.
NCI Questions to Ask Your
Find a Clinical
our database of clinical trials at the Chao Family Comprehensive Cancer Center
that are currently enrolling new participants.
note that our clinical trials information is updated periodically, so there is
the potential that a trial listed as open on this site may not be open any
longer. Similarly, there may be trials available in addition to
those listed here. We recommend contacting the Clinical Trials toll
free number at 877.UC.STUDY (877.827.8839) or email firstname.lastname@example.org to confirm clinical trial
availability and/or to get further information about specific trials.
Search for open clinical trials
|National Cancer Institute (NCI)
Authoritative, detailed information and search mechanism for cancer clinical trials nationwide
|"Introduction to Clinical Trials"
The basics on clinical trials, also from the NCI
Helpful resources, including a podcast, from the American Society of Clinical Oncology
Registry of all clinical trials — for cancer and other medical conditions — from the National Institutes of Health (NIH)