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Search for Clinical
Trials
What are clinical
trials?
What are the phases of
trials?
How do I and should I participate in a
clinical trial?
What is informed
consent?
What questions should I
ask?
Where do I find trials that might be
available to me?
What are clinical
trials?
Clinical trials are medical research
trials involving patients that are carried out to try and find new
and better treatments. They are carried out in all areas of
medicine, not just in cancer, and not just to test treatment. For
example, a clinical trial might be used to compare different ways of
diagnosing an illness. Or it might test techniques for preventing a
particular cancer. Some trials also include a study of the
psychological and financial effects of the treatment, both on
patients and their caretakers (for example, whether someone has to take
time off work to look after you).
At the present time about 1 in 25 cancer patients
take part in clinical trials. If more patients were involved in
clinical trials, cancer research would be able to move forward more
quickly. Trials are more commonly used with some cancers than with
others. Clinical trials are most commonly used to try out new forms
of treatment such as surgery, radiotherapy or chemotherapy, to
control symptoms such as pain and sickness, or to test the
effectiveness of psychological therapy. The treatment being tested
may be aimed at improving survival, relieving symptoms of the cancer
or side effects of treatment, or improving the quality of life or
sense of well-being for people with cancer.
Many drugs which have been tested in clinical trials
are now in common use, such as tamoxifen in breast cancer and
cisplatin for testicular cancer.
What types
of trials are available?
Phase 1
Phase 1
trials of new cancer treatments use drugs which have been tested on
cancer cells in the laboratory and have had an effect. Phase 1 is
the first stage in which the drugs are used to treat patients. These
studies have small numbers of patients. Phase 1 drugs are offered to
people whose cancer has come back or spread, and there is no other
standard treatment that may help them. It is not expected that the
treatment will cure the cancer; rather, the trial aims to find out:
- How much of the treatment can be given without
causing serious side effects.
- Which side effects the drug causes.
- Whether the drug has any effect on the cancer.
In a phase 1 trial the first group of between 3 to 6
patients are given a small dose that is expected to be safe. If none
of the patients have any side effects the next group of patients
will be given a higher dose. In this way the dose of the drug is
increased until some people do have side effects. When side effects
are seen that make it unsafe to increase the dose further it is
known as the Maximum Tolerated Dose and the dose is not increased
any more.
it is impossible to predict whether a new treatment
will cause harmful side effects in people, and it is important that
patients in this type of trial are monitored carefully. Phase 1
trials are usually carried out in clinical research units at
specialist hospitals, rather than in local hospitals, and this may
involve a lot of travelling to and from the centre.
If the drug has an effect on the cancer, and a safe
dose has been found, the drug will then be tested in phase 2 trials.
Phase 2
By the
time a treatment reaches phase 2, researchers will know quite a lot
about it. The phase 1 trials will have shown what the major side
effects are and whether the drug actually has some effect on
particular types of cancer. The aim of phase 2 trials is to look at
how many people the treatment is effective for and which types of
cancer it might be used to treat. Researchers will know which side
effects may occur so they can deal with these straight away if
necessary.
Phase 2 studies have more patients, perhaps a few
dozen. These patients will be closely monitored to see whether their
cancer is getting smaller. If the cancer does shrink this is known
as a response to treatment. The trial will also
look at any side effects caused by the treatment. Sometimes phase 2
studies include different ways of giving the new treatment; for
example, patients may be given the same drug by injection, or as
tablets. These trials may be randomized.
Phase 3
These
studies follow phase 2 and the main aim is to compare the
effectiveness and safety of the treatment being tested with current
treatments. Hopefully, one will be found to be more effective,
although it may be just as useful to find that they are all equally
effective but one has fewer side effects. Phase 3 trials are large
and usually include hundreds, or sometimes thousands, of patients
from many different hospitals, often from several countries.
Researchers measure various aspects, such as whether the growth of
the cancer slows, and, in the longer term, how long patients remain
free of cancer. Researchers may also measure how the treatment
affects patients' quality of life. Phase 3 trials always involve
randomization.
How do I and should I participate in a
clinical trial?
Each study has its own guidelines for who can
participate, called eligibility criteria. Generally,
participants in a study are alike in key way, such as the type and
stage of cancer, age, gender, or previous treatments. The
eligibility criteria are included in the study plan. To find out if
you are eligible for a particular study, talk to your medical
oncologist or current physician to investigate any options available
to you.
You will almost always need a physician to
refer you to be enrolled into a trial that is
being run locally or from a larger hospital. It is important to
remember that some hospitals do not have the facilities or expertise
to take part in some trials, so it may mean that, if you are able to
take part in a research study, you will have to travel to a
different hospital. If you have been invited to take part in a
clinical trial you may be introduced to a research nurse who can
tell you all about the trial and will be able to answer your
questions.
Only you can make the decision about whether or not
to participate in a clinical trial. Before you make your decision,
you should:
- learn as much as possible about your disease and
the trials that are available to you. Research trial databases
for general cancer information, as well as for
guidance on how to find current clinical trials that might be
appropriate for you.
- Then, talk about this information and how you
feel about it with your doctor and/or nurse, family members and
friends to help you determine what is right for you.
Clinical trials are carefully designed to minimize
the risks, and maximize the benefits, to all the people who take
part, regardless of which treatment they get.
When you take part in a trial you will be monitored
carefully during and after the study. You will have regular tests
and you may be asked some extra questions about how you are feeling.
This will likely mean you will be on a strict visit schedule
and seeing your medical oncologist often weekly for varying periods
of time, so bear this in mind before you agree to take part.
Potential benefits
include:
- Health care provided by
leading physicians in the field of cancer research.
- Access to new drugs and
interventions before they are widely available.
- Close monitoring of
your health care and any side effects.
- A more active role in
your own health care.
- If the approach being
studied is found to be helpful, you may be among the first to
benefit.
- An opportunity to make
a valuable contribution to cancer research.
The potential
risks include:
- New drugs and
procedures may have side effects or risks unknown to the doctors.
- New drugs and
procedures may be ineffective, or less effective, than current
approaches.
- Even if a new approach
has benefits, it may not work for you.
What is informed
consent?
Informed consent is the
process of learning the key facts about a clinical trial before
deciding whether or not to participate. It is also a continuing
process throughout the study to provide information for
participants. To help someone decide whether or not to participate,
the doctors and nurses involved in the trial explain the details of
the study. If the participant's native language is not English,
translation assistance can be provided. Then the research team
provides an informed consent document that includes details about
the study, such as its purpose, duration, required procedures, and
key contacts. Risks and potential benefits are explained in the
informed consent document. The participant then decides whether or
not to sign the document. Informed consent is not a contract, and
the participant may withdraw from the trial at any time.
What questions should
I ask?
1. What is the point of the trial and how will
it help people?
2. What is the trial
called?
3. Who will be in charge of my care?
4. Where will I have my medical care?
5. How long will the study
last?
6. Can I withdraw from the trial? The
answer is always `yes'.
7. How much of my time
will be needed?
8. What are my possible
short-term benefits?
9. What are my possible
long-term benefits?
10. Will I need extra help from
family and friends?
11. Will I have to pay for any part of
the trial such as tests or the study drug?
If so, what will the
charges likely be?
12. What is my health insurance
likely to cover?
13. Who can help answer any questions
from my insurance company or health plan?
14. Will there
be any travel or child care costs that I need to consider while I am
in the trial?
15. Will I have extra tests? If so,
what will they be?
16. What are the possible side effects
of my treatment?
17. How may the treatment affect me
physically and emotionally?
18. Who can I contact if I have
a problem? Will someone be available 24 hours a day?
19.
Can I talk to other people in the study?
20. What other options do
people with my risk of cancer or type of cancer have?
Where do I find
trials that might be available to me?
For trials being
conducted in the U.S.:
Centerwatch Clinical Trials Listing Service
Childrens Oncology Group
National Cancer
Institute - Cancer.gov - Clinical Trials
Cancer411.org - Comprehensive Cancer Clinical Trials Information
ClinicalTrials.gov - Linking
Patients to Medical Research
Patient-Centered Guides Cancer Clinical Trials Center
SWOG - Southwest Oncology
Group
For
trials being conducted abroad:
Clinical Trials.gov
Cancer Research UK
EORTC - European
Organisation for Research and Treatment
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