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General Clinical Trial Information
What is a Clinical Trial?
 Clinical
trials are research studies in which people help doctors, medical
device companies and pharmaceutical companies find ways to improve
health care. Each study tries to answer scientific questions and
to find better ways to prevent, diagnose, or treat certain diseases.
We are providing you this booklet on cancer clinical trials to
review because while focused primarily on cancer clinical trials,
a large part of the information is relevant to all clinical trials
that are drug related and focused on treating a specific therapeutic
area. This booklet is well written and easy to understand. Click
here to download the booklet
in PDF format.
The sections of the booklet are:
- What are clinical trials?
- What happens in a clinical trial?
- Should I take part in a clinical trial?
The first two sections provide background information on the important
role clinical trials play in improving cancer care. They also
explain some of the technical terms you may hear from your doctor
or nurse. Words that appear in as bold links are defined in the
Glossary.
The third section of the booklet is designed to help you answer
question 3 for yourself. It raises issues to think about as you
decide whether a clinical trial is right for you. For example,
what are the pros and cons of being in a clinical trial from the
patient's point of view? This section also lists some questions
to ask the doctor or nurse about any study you are considering.
Why are there clinical trials?A clinical
trial is one of the final stages of a long and careful disease
research process. Studies are done with people with specific therapeutic
conditions to find out whether promising approaches to prevention,
diagnosis, and treatment are safe and effective.
What are the different types of clinical trials? Treatment
trials test new treatments (like a new specific disease drug,
new approaches to surgery or radiation therapy, new combinations
of treatments, or new methods such as gene therapy).
Prevention trials test new approaches, such as medicines,
vitamins, minerals, or other supplements that doctors believe
may lower the risk of a certain type of disease. These trials
look for the best way to prevent certain diseases in people who
have never had a specific disease or condition or to prevent certain
conditions or diseases from coming back or a new disease occurring
in people who have already had certain diseases.
Screening trials test the best way to find certain diseases,
especially in the early stages of a disease or condition. Screening
trials tests new ways of finding cancer in people before they
have any cancer symptoms. These methods of detecting cancer, often
called screening tests, can include:
- Imaging Tests - Tests that produce pictures of areas
inside the body.
- Laboratory Tests - Tests that check blood, urine,
and other body fluids and tissues.
- Genetic Tests - Tests that look for inherited genetic
markers linked to specific diseases or conditions.
Quality of Life trials (also called Supportive Care trials)
explore ways to improve comfort and quality of life for certain
diseases in patients. These studies, often called supportive care
trials, may study drugs to reduce side effects from primary treatments.
For example, problems encountered by cancer patients, such as
fatigue, nausea, pain, weight loss, a risk for second cancers,
and depression are getting more attention from researchers. Other
supportive care studies look for beneficial effects of nutrition,
group therapy, and other approaches.
What are the phases of clinical trials? Most clinical research
that involves the testing of a new drug progresses in an orderly
series of steps, called phases. This allows researchers to ask
and answer questions in a way that results in reliable information
about the drug and protects the patients. Clinical trials are
usually classified into one of three phases:
- Phase I trials: These first studies in people evaluate
how a new drug should be given (by mouth, injected into the
blood, or injected into the muscle), how often, and what dose
is safe. A Phase I trial usually enrolls only a small number
of patients, sometimes as few as a dozen.
- Phase II trials: A phase II trial continues to test
the safety of the drug, and begins to evaluate how well the
new drug works. Phase II studies usually focus on a particular
type of certain diseases.
- Phase III trials: These studies test a new drug,
a new combination of drugs, or a new surgical procedure in
comparison to the current standard. A participant will usually
be assigned to the standard group or the new group at random
(called randomization). Phase III trials often enroll large
numbers of people and may be conducted at many doctors' offices,
clinics, and certain diseases centers nationwide
- Phase IV trials: These are marketing trials or comparison
trials of already approved drugs, devices or procedures.
How are clinical trials conducted? In a clinical trial, patients receive treatment
and doctors carry out research on how the treatment affects the
patients. While clinical trials have risks for the people who
take part, each study also takes steps to protect patients.
What Is It Like To Receive Treatment in a Study?
 When
you take part in a clinical trial, you receive your treatment
in a medical center, hospital, clinic, and/or doctor's office.
Doctors, nurses, social workers, and other health professionals
may be part of your treatment team. They will follow your progress
closely. You may have more tests and doctor visits than you would
if you were not taking part in a study. You will follow a treatment
plan your doctor prescribes, and you may also have other responsibilities
such as keeping a log or filling out forms about your health.
Some studies continue to check on patients even after their treatment
is over.
How Is the Research Carried Out? How Are Patients
Protected?
In clinical trials, both research concerns and patient well-being
are important. To help protect patients and produce sound results,
research with people is carried out according to strict scientific
and ethical principles. These include:
1. Each clinical trial has an action plan (protocol) that explains
how it will work.
The study's investigator,
usually a doctor, prepares an action plan for the study. Known
as a protocol,
this plan explains what will be done in the study and why. It
outlines how many people will take part in the study, what medical
tests they will receive and how often, and the treatment plan.
The same protocol is used by each doctor that takes part in the
study.
For patient safety, each protocol must be approved by the organization
that sponsors the study (such as a pharmaceutical company) and
an Institutional
Review Board (IRB) at each hospital or other study site. This
board, which includes consumers, clergy, and health professionals,
reviews the protocol to try to be sure that the research will
not expose patients to extreme or unethical risks.
2. Each study enrolls people who are alike in key ways.
Each study's protocol
describes the characteristics that all patients in the study must
have. Called eligibility criteria, these guidelines differ from
study to study, depending on the research purpose. They may include
age, gender, the type and stage
of disease, and whether patients who have had prior treatment
for the specific disease or condition or who have other health
problems can take part.
Using eligibility criteria is an important principle of medical
research that helps produce reliable results. During a study,
they help protect patient safety, so that people who are likely
to be harmed by study drugs or other treatments are not exposed
to the risk. After results are in, they also help doctors know
which patient groups will benefit if the new treatment being studied
is proven to work. For instance, a new treatment may work for
one type of a disease but not for another, or it may be more effective
for men than women.
Should I enroll in a clinical trial?
This is a question only you can answer after careful thought and
consultation with a health care professional. Learning you have
a serious disease and deciding what to do about it is often overwhelming.
This section has information you can use in thinking about your
choices and making your decision.
Pros and Cons of Clinical Studies:
While a clinical trial is a good choice for some people, this
treatment option has possible benefits and drawbacks. Here are
some factors to consider. You may want to research them and discuss
them with your doctor.
Possible Benefits
- Clinical trials offer high-quality care. If you are in a
study and do not receive the new treatment being tested, you
will receive the best standard
treatment. This may be as good as, or better than, the
new approach.
- If a new treatment approach is proven to work and you are
taking it, you may be among the first to benefit.
- By looking at the pros and cons of clinical trials and your
other treatment choices, you are taking an active role in
a decision that affects your life.
- You have the chance to help others and improve treatment
of the relevant disease.
- In some cases, your health care costs are paid for by the
sponsor of the study while you are enrolled in the study.
Possible Drawbacks
- New treatments under study are not always better than, or
even as good as, standard care. They may have side
effects that doctors do not expect or that are worse than
those of standard treatment.
- Even if a new treatment has benefits, it may not work for
you. Even standard treatments, proven effective for many people,
do not help everyone.
- If you receive standard
treatment instead of the new treatment being tested, it
may not be as effective as the new approach.
- Health insurance and managed care providers do not always
cover all patient care costs in a study. What they cover varies
by plan and by study. To find out in advance what costs are
likely to be paid in your case, talk to a doctor that is involved
in the study.
Your Rights, Your Protections
Before and during a clinical trial, you have a number of rights.
Knowing these can help protect you from harm.
- Taking part in a clinical trial is up to you. It may be
only one of your treatment choices. Talk with your doctor.
Together, you can make the best choice for you.
- If you do enter a study, doctors and nurses will follow
your response to treatment carefully throughout the research.
- If researchers learn that a treatment harms you, you will
be taken off the study right away. You may then receive other
treatment from your own doctor.
- You have the right to leave a study at any time.
One of your key rights is the right to informed
consent. Informed consent means that you must be given all
the facts about a study before you decide whether to take part.
This includes details about the treatments and tests you may receive
and the possible benefits and risks they may have. The doctor
or nurse will give you an informed consent form that goes over
key facts. If you agree to take part in the study, you will be
asked to sign this informed consent form. The doctor may print
this form from a computer or ask you to do what is called an electronic
signature on the computer stating that you have been informed
and provide your consent.
The informed consent process continues throughout the study. For
instance, you will be told of any new findings regarding your
clinical trial, such as new risks. You may be asked to sign a
new consent form if you want to stay in the study. Companies like
SelecTrials that provide Internet based clinical trial
management solutions store these records in a database and can
provide you with an audit report of any and all information that
has been collected, disseminated or otherwise generated about
you during the course of the clinical trial.
Signing a consent form does not mean you must stay in the study.
In fact, you can leave at any time. If you choose to leave the
study, you will have the chance to discuss other treatments and
care with your own doctor or a doctor from the study.
Questions You Should Ask
Finding answers and making choices may be hard for people with
serious diseases and those who care about them. It is important
to discuss your treatment choices with your doctor, a disease
specialist to whom your doctor may refer you, and the staff of
any clinical trial you consider entering.
Ask questions about the information you receive during the informed
consent process and about any other issues that concern you. Getting
answers can help you work better with the doctor. Ask what communications
platforms exist so that you can communicate information to the
doctor or the doctor’s staff that are running the study if you
need to do so. You may want to take a friend or relative along
when you talk to the doctor. It also may help to write down your
questions and the answers you receive, or bring a tape recorder
to record what is said. No question about your care is foolish.
It is very important to understand your choices.
Here are some questions you may want to ask about:
The Study
- What is the purpose of the study? In what phase is this
study?
- Why do researchers believe the new treatment being tested
may be effective? Has it been tested before? If so, were the
tests on humans and what were the results?
- Who sponsors the study, and who has reviewed and approved
it?
- How are the study data and patient safety being checked?
- When and where will study results and information go?
- Will information about me be retained by the doctor that
I see during the study? If so, will my regular doctor get
a copy?
Possible Risks and Benefits
- What are the possible short- and long-term risks, side
effects, and benefits to me?
- Are there standard treatments for my type of the specific
disease?
- How do the possible risks, side
effects, and benefits in the study compare with standard
treatment?
Your Care
- What kinds of treatments, medical tests, or procedures will
I have during the study? Will they be painful? How do they
compare with what I would receive outside the study?
- How often and for how long will I receive the treatment,
and how long will I need to remain in the study? Will there
be follow-up after the study?
- Where will my treatment take place? Will I have to be in
the hospital? If so, how often and for how long?
- How will I know if the treatment is working?
- Will I be able to see my own doctor? Who will be in charge
of my care?
Personal Issues
- How could the study affect my daily life?
- Can you put me in touch with other people who are in this
study?
- What support is there for me and my family in the community?
Cost Issues
- Will I have to pay for any treatment, tests, or other charges?
- What is my health insurance likely to cover?
- Who can help answer any questions from my insurance company
or managed care plan?
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