Alzheimer's Disease Clinical Trial
Participating in a Clinical Trial
Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions will provide you with detailed information about clinical trials. In addition, it is often helpful to talk to your healthcare provider, family members, or friends about deciding to join a trial. After you have identified some trial options, the next step is to contact the study research staff and ask questions about specific trials.
To search the National Library of Medicine's clinical trials database and locate clinical trials investigating Alzheimer's disease, click here.
What is a clinical trial?
A clinical trial is a research study involving human subjects to
answer specific questions about vaccines or new therapies, or new
ways of using known treatments. Clinical trials (also called medical
research and research studies) are used to determine whether new
drugs or treatments are both safe and effective. Carefully conducted
clinical trials are the fastest and safest way to find treatments
that work.
Ideas for clinical trials usually come from researchers.
Pre-clinical trials typically study the actions of potential
treatments in laboratory culture dishes or test tubes - called in
vitro studies - or in laboratory animals such as mice, rats or
monkeys. Once researchers test new therapies or procedures in the
laboratory and get promising results, they begin planning Phase I
clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.
To find current clinical trials, please click on the link provided: Alzheimer's Disease Clinical Trials
What is a protocol?
All clinical trials are based on a set of rules called a
protocol. A protocol describes what types of people may participate
in the trial; the schedule of tests, procedures, medications, and
dosages; and the length of the study. While in a clinical trial,
participants are seen regularly by the research staff to monitor
their health and to determine the safety and effectiveness of their
treatment.
^
Back to Top
What are clinical trial phases?
Clinical trials of experimental drugs proceed through four
phases:
- In Phase I clinical trials, researchers test a new drug or
treatment in a small group of people (20 to 80) for the first time
to evaluate its safety, determine a safe dosage range and identify
side effects.
- In Phase II clinical trials, the study drug or treatment is
given to a larger group of people (100 to 300) to see if it is
effective and to further evaluate its safety.
- In Phase III studies, the study drug or treatment is given to
large groups of people (1,000 to 3,000) to confirm its
effectiveness, monitor side effects, compare it to commonly used
treatments and collect information that will allow the drug or
treatment to be used safely.
- Phase IV studies are done after the drug or treatment has been
marketed. These studies continue testing the study drug or
treatment to collect information about their effect in various
populations and any side effects associated with long-term use.
^
Back to Top
What protections are there for
people who participate in clinical trials?
The government has strict guidelines and safeguards to protect
people who choose to participate in clinical trials. Every clinical
trial in the U.S. must be approved and monitored by an Institutional
Review Board (IRB) to make sure the risks are as low as possible and
are worth any potential benefits. The "institution" in IRB is
usually a university or a hospital.
An IRB is an independent committee of physicians, statisticians,
community advocates and others that ensures that a clinical trial is
ethical and the rights of study participants are protected. By
federal regulation, all institutions that conduct or support
biomedical research involving people must have an IRB that initially
approves and periodically reviews the research.
^
Back to Top
What is informed consent?
Informed consent is the process of learning the key facts about a
clinical trial before you decide whether or not to participate.
These facts include:
- Why the research is being done.
- What the researchers want to accomplish.
- What will be done during the trial and for how long.
- What risks are involved in the trial.
- What benefits can be expected from the trial.
- What other treatments are available.
- The fact that you have the right to leave the trial at any
time.
If you are considering joining a clinical trial, the research
staff will give you informed consent documents that include the
details about the study. If English is not your native language, you
can ask for the consent documents in languages other than English.
Since joining a clinical trial is an important decision, you should
ask the research team any questions you may have about the study and
the consent forms before you make a decision.
It is also a good idea to take the consent documents home and
discuss them with family members or friends. Talking about your
options can help you to feel comfortable with your decision. If you
decide to join the clinical trial, be sure to ask for a copy of the
informed consent documents so you can review them at any time.
Remember, informed consent is more than signing a form. It is a
process that continues throughout the study. You should feel free to
ask the research team questions before, during and after the study.
Informed consent continues as long as you are in the study.
People suffering from Alzheimer's disease may not be mentally
capable of giving consent, in which case the consent process must be
conducted by next-of-kin or a person granted power of attorney.
^
Back to Top
Who can participate in a
clinical trial?
All clinical trials have guidelines about who can get into the
program. Guidelines are based on such factors as age, type of
disease, medical history and current medical condition. Before you
join a clinical trial, you must qualify for the study. Some research
studies seek volunteers with illnesses or conditions to be studied
in the clinical trial, while others need healthy volunteers. Healthy
volunteers participate in Phase I trials, vaccine studies, and
trials on research on preventive care for children or adults.
The factors that allow you to participate in a clinical trial are
called inclusion criteria and the factors that keep you from
participating are called exclusion criteria. It is important
to note that inclusion and exclusion criteria are not used to reject
people personally. Instead, the criteria are used to identify
appropriate participants and keep them safe. The criteria help
ensure that researchers will be able to answer the questions they
plan to study.
^
Back to Top
Who sponsors clinical
trials?
Clinical trials are sponsored by government agencies: such as the
National Institutes of Health (NIH); pharmaceutical companies;
individual physician- investigators; health care institutions such
as health maintenance organizations (HMOs); and organizations that
develop medical devices or equipment. Trials can take place in a
variety of locations, such as hospitals, universities, doctors'
offices, or community clinics.
^
Back to Top
What happens during a clinical
trial?
The clinical trial process depends on the kind of trial you
participate in. The team will include doctors and nurses as well as
social workers and other health care professionals. They will check
your health at the beginning of the trial, give you specific
instructions for participating in the trial, monitor you carefully
during the trial, and stay in touch with you after the study. It is
important to realize that in some cases, depending on the trial,
there may be NO feedback or NO individual feedback directly to the
participant.
Some clinical trials involve more tests and doctor visits than
you would normally have for your illness or condition. For all types
of trials, you will work with a research team. Your participation
will be most successful if you follow the protocol carefully
and stay in contact with the research staff. Some terms that will
help you understand what happens in a trial are defined below.
^
Back to Top
A placebo (sometimes called a "sugar
pill") is an inactive pill, liquid, or powder that has no treatment
value. In clinical trials, experimental treatments are often
compared with placebos to assess the treatment's effectiveness. In
some studies, the participants in the control group will receive a placebo instead of an
active drug or treatment.
^
Back to Top
A control is the standard by which experimental observations are
evaluated. In many clinical trials, one group of patients will be
given an experimental drug or treatment, while the control group is
given either a standard treatment for the illness or a placebo.
^
Back to Top
A blinded or masked
study is one in which participants do not
know whether they are in the experimental or control group in a
research study. Those in the experimental group get the medications
or treatments being tested, while those in the control group get a
standard treatment or no treatment.
^
Back to Top
A double-blind or double-masked study is one in which neither the
participants nor the study staff know which participants are
receiving the experimental treatment and which ones are getting
either a standard treatment or a placebo. These studies are
performed so neither the patients' nor the doctors' expectations
about the experimental drug can influence the outcome.
^
Back to Top
What are side effects and
adverse reactions?
Side effects are any undesired actions or effects of drug or
treatment. Negative or adverse effects may include headache, nausea,
hair loss, skin irritation or other physical problems. Experimental
treatments must be evaluated for both immediate and long-term side
effects.
In many Alzheimer's trials, the person with the disease is
essentially a passive bystander. The processing of information about
the trial and decision-making are the responsibility of the
caregiver, spouse, next-of-kin or person designated with
power-of-attorney.
^
Back to Top
What are the benefits and risks
associated with clinical trials?
There are both benefits and risks associated with clinical
trials. By participating in a clinical trial, you can:
- Take an active role in your own health care.
- Gain access to new treatments that are not available to the
public.
- Obtain expert medical care at leading health care facilities
during the trial.
- Help others by contributing to medical research.
Clinical trials have risks:
- There may be side effects or adverse reactions to medications
or treatments.
- The treatment may not be effective for you.
- The protocol may require a lot of your time for trips
to the study site, treatments, hospital stays, or complex dosage
requirements.
^
Back to Top
What should I know before I
join a clinical trial?
You should know as much as possible about the research study. It
is important for you to feel very comfortable asking questions and
the staff should answer them in a way you can understand. A list of sample questions appears below.
^
Back to Top
How should I prepare for the
meeting with the research coordinator or doctor?
- Plan ahead and write down the questions you want to ask.
- Ask a friend or relative to come with you for support and to
hear the responses to your questions.
- Bring a tape recorder so you can replay the discussion after
you get home.
^
Back to Top
What questions should I ask?
Some questions you might ask about the research include:
- Why is this research being done?
- What is the purpose of the study?
- Who is sponsoring the study?
- Who has reviewed and approved this study?
- Why does the research team think the treatment, drug or
medical device will work?
Some questions about your participation in the study include:
- Where is the study site?
- What kinds of therapies, procedures, and/or tests will I have
during the trial?
- Will they hurt? If so, for how long?
- How will the tests in the study compare to tests I would have
outside the study?
- How long will the study last?
- How often will I have to go to the study site?
- Who will provide my medical care after the study ends?
- Will I be able to take my regular medications during the
trial?
- What medications, procedures or treatments must I avoid while
in the study?
- What are my responsibilities during the study?
- Will I have to be in the hospital during the study?
- Will the study researchers work with my doctor while I am in
the study?
- Can anyone find out that I am participating in a study?
- Can I talk to other people in the study?
- Will I be able to find out the results of the trial?
Questions about risks and benefits include:
- How do the possible risks and benefits of the study compare
with approved treatments for me?
- What are the possible immediate and long-term side effects?
- Can my DNA test results be used to deny me insurance benefits
or employment?
Other questions include:
- What other treatment options do I have?
- Will I have to pay anything to participate in the study?
- What are the charges likely to be?
- Is my insurance likely to cover those expenses?
^
Back to Top
Should I continue working with
my primary health care provider if I participate in a trial?
Yes. Most clinical trials provide short-term treatments related
to a designated illness or condition, but not extended or complete
primary health care. In addition, by having your health care
provider work with the research team, you can ensure that your other
medications or treatments will not conflict with the clinical trial
protocol.
^
Back to Top
Can I leave a clinical trial
after it has begun?
Yes. You can leave a clinical trial at any time. If you plan to
stop participating, let the research team know why you are leaving
the study.
^
Back to Top
Will I be paid for
participating in a clinical trial?
Some clinical trials will pay you for joining the trial, while
others will not. In some programs, researchers will reimburse you
for expenses associated with participating in the research. Such
expenses may include transportation costs, child care, meals and
accommodations.
Courtesy of: National Institute for Allergy and Infectious
Diseases
^
Back to Top
|
