What is a clinical trial?
A clinical trial is a type of research study that tests how well new medical approaches work in
people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease.
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Who can participate in a clinical trial?
To qualify for a particular study, patients must meet a carefully defined set of criteria. Those
criteria usually relate to patients' age and gender, the type and severity of their condition, and
the types of treatments they have already received.
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Why should a patient consider participating in a clinical trial?
Over the last few years a lot of new and very effective drugs, that have less toxic side effects, have
been developed and approved. Voluntary participation in clinical trials may help to extend and improve
the quality of life of cancer patients. If you are considering a clinical trial, you should discuss the
pros and cons of participating in the trial with your physician.
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What information do patients receive about clinical trials?
Patients interested in participating in a clinical trial are informed in advance about the possible
risks and benefits of the modality being studied, and their written consent is obtained before the
experimental therapy begins. As the trial progresses, participants are given new information that may
affect their willingness to stay in the trial. Participants may withdraw from the trial at any time.
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What steps does a patient need to take to participate in a clinical trial?
First, the participant has an initial consultation where they meet with their physician or with the
research nurse. The physician informs them about the different options available, including standard
therapies and research trials when appropriate. In discussing the trial, the participant is provided with
a general overview of the protocol (the action plan for the clinical trial), potential side effects, the
time commitment involved, and the procedures that need to be done.
The participant is then provided with a copy of the informed consent to review at home. If, after careful
consideration, they are interested in participating in the trial, he or she comes in for a follow-up
appointment. During that visit, we answer any additional questions about the informed consent and the study.
At any time, the participant may opt for standard therapy or no therapy at all.
Once the consent form is signed, the participant will undergo a full physical examination. We will record
their medical history and schedule him or her for all of the required screening tests. The results of the
tests will be reviewed by the clinical team, and if it is determined that the participant meets the eligibility
criteria for the trial, we will register him or her in the study.
How are patients protected?
Every healthcare facility has an Institutional Review Board (IRB) which reviews and approves all proposed
studies. The IRB is designed to protect the people who take part in a clinical trial. They check to see
that the trial is well designed, legal, ethical, does not involve unnecessary risks, and includes safeguards
for participants.
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Do clinical trials require a time commitment?
Yes. When you are in a clinical trial there are stringent guidelines that need to be followed. It's not that
easy to deviate from the set plan. That's why we let participants know during the consent process that it does
require a serious commitment.
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What are the different phases of a clinical trial?
Clinical trials test new approaches to the diagnosis, treatment, or prevention of cancer in people. Clinical
trials are carried out in steps called phases. Each phase is designed to find different information.
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Phase I
The purpose of Phase I studies is to find the best way to administer an experimental therapy and how much of
it can be given safely. In a Phase I study, an experimental therapy is given to a small number of people.
Although the experimental therapy has been well tested in laboratory and animal studies and has shown preliminary
activity, the side effects in people cannot be completely known ahead of time. For this reason, the effects of
Phase I clinical trials may involve significant risks to some participants. They are offered only to people whose
cancer cannot be helped by other known treatments.
Phase II
Phase II studies are designed to find out if the experimental therapy actually controls cancer cells in people.
Usually groups of 20 to 50 participants with one type of cancer receive a Phase II modality. Participants are
closely observed to see if the tumor has shrunk since the beginning of the trial. If an experimental therapy has
shown activity against cancer in a Phase II trial, it becomes part of a Phase III trial.
Phase III
Phase III studies usually compare standard treatments (the treatment most accepted) with experimental therapies
that appeared to be promising in Phase II studies. Phase III trials require large numbers of participants.
Participants are usually randomized, which means they are assigned by chance to one of the modalities being
studied. Phase III studies look for longer life, better quality of life, fewer side effects, and fewer cases
of the cancer returning.
