Participation In Clinical Trials: What You Should Know.
Yes. The treatments used in clinical trials can cause side effects and risks
depending on the type of treatment and the individual. Side effects vary from
person to person.
Because clinical trials are research into new areas of treatment, the risks
involved are not always known ahead of time, though efforts have been made to
find out what they might be. For this reason, trials can carry unknown dangers
and side effects as well as hoped for benefits. Subjects need to know what is
involved in a study, what side effects may be expected and, as much as possible,
what "unknowns" or uncertainties they may be facing.
You will be told about the treatments being tested and will be given a form
to read that discusses the risks and hoped for benefits. If you agree to take
part, you will be asked to sign a form, called the informed consent form. Before
you sign, be sure you understand what risks you face. Ask the staff of The Center
for Health Behavior Research to explain any parts of the form or the trial that
are not clear. If you do not want to be in the trial, you may refuse. Even if
you sign the form, you are free to leave the trial at any time. However, you
are requested to complete the necessary procedures for discontinuation.
If You're Thinking of Entering A Clinical Trial, Are You Eligible?
Every clinical trial is designed to answer a set of research questions. If
you fit the guidelines for a trial, you may be eligible to take part.
What Is Best For You?
This is a big question. Finding answers and making decisions are often hard
for subjects. Deciding what treatment to use can be overwhelming. It is important
to discuss your options with experts. Ask questions about the problems you are
facing. If you understand what is going on, you can work more effectively toward
Take time to ask questions and to discuss what you want to know. It may help
if you write questions down ahead of time. No question is foolish. Learn what
is available to you. Discover your choices, each individual is different. You
are an individual with individual needs, and your health is important.
As you decide about treatment, whether it is in a clinical trial, remember
that you are not alone. There are many people to help you: counselors, your
family, physician, and friends. Although it is YOUR decision, they can help
you think about it and decided what is best for you.
What Are Important Questions To Ask About A Clinical Trial?
If you are thinking about taking part in a clinical trial, here are some important
questions to ask:
- What is the purpose of the study?
- What does the study involve? What kind of treatments? (Find out what procedures
will be performed.)
- What other choices are available to me, and what are their advantages and
disadvantages? (Are there standard treatments and how does the study compare
- How could the study affect my daily life?
- What side effects could I expect from the study? (Side effects can also
occur from standard treatments.)
- How long will the study last? Will it require an extra time commitment
on my part?
- How much will the study cost me?
- What type of long term follow-up care is part of the study?
What Is Informed Consent?
Informed consent, a key part of a good clinical trial, is required in studies
that are federally regulated or funded as well as by many state laws. Informed
consent means that as a subject, you are given information so you can understand
what is involved in a trial, including its potential benefits and risks, and
then decide freely to take part in it or not. The staff of The Center for Health
Behavior Research explains the nature of the treatment. You are given an Informed
Consent form to read and consider carefully. Ask any questions you may have;
then if you agree to take part, sign the form. You may also refuse; however,
you will be unable to participate in the clinical trial.
Informed consent is an ongoing process. You will continue to receive any new
information about your treatment that may affect your willingness to stay in
the trial. Signing a consent form does not bind you to the study. You can still
leave at any time; however you are requested to complete the necessary procedures
What Is It Like To Be A Patient In A Clinical Trial?
For some people, myths and fears of "experimentation" or of being
a "Guinea pig" come with the idea of clinical trials. And, surely,
there are fears of the unknown. Understanding what is involved can ease some
of your anxieties. Subjects in a clinical trial, for example, receive their
care in the same places that standard treatments are given-at cancer centers,
clinics, or research centers.
If you join a research study, you will be watched closely and data on your case
will be carefully recorded. You may be required to complete daily diaries and
attend weekly appointments. You may also be asked to complete questionnaires
and provide information at these visits. (This allows the investigator to follow
your progress as well as to collect study data.) Although this can be inconvenient,
the information will assure an extra ounce of observation along the way. During
the course of a study, if it is clear that a treatment is not in your best interest,
you will be removed from the study and you can discuss other options.
Can You Leave A Trial At Any Time?
Yes. Just as you can refuse to join a study, you may leave a study at any time.
Your rights as an individual do not change because you are a subject in a clinical
trial. You may choose to take part or not, and you can always change your mind
later, even after you enter a trial. However, you are requested to complete
the necessary discontinuation procedures.
You may also refuse to take part in any aspect of the research. If you have
questions at any time about any part of the study, be sure to ask the staff
at The Center for Health Behavior Research. If you are not satisfied with the
answers, you may consider leaving the study. If you decide to leave, it will
not be held against you.
What Protection Do You Have As A Patient In A Clinical Trial?
The ethical and legal codes that govern medical practice apply to clinical
trials. In addition, most clinical research has built in safeguards to protect
subjects. These safeguards include regular review of the protocol (the study
plans) and the progress of each study by researchers at other places.
For example, an Institutional Review Board (IRB) must first approve clinical
trials. The IRB is designed to protect subjects, and is comprised of scientists,
physicians, clergy and other people from your local community. An IRB reviews
a study to see that it is well designed with safeguards for subjects, and that
the risks are reasonable in relation to the potential benefits.
A well-run clinical trial is carefully reviewed for medical ethics, subject
safety, and scientific merit by the research institution. Every study should
provide for monitoring the data and the safety of subjects on an ongoing basis.
As discussed earlier, informed consent is also an important process that helps
After subjects join a clinical trial and it progresses, the investigator reports
the results of the trial to scientific meetings, to medical journals whose articles
are approved by experts, and to various government agencies.
What Can Help You Learn If A Trial Is Sound And Well Run?
Things that make a sound, well-run trial to safeguard subjects include the
items discussed in the previous section. Keeping these items in mind, here are
some important questions for you to ask to find out if a study is well-run:
- What is its purpose?
- Who has reviewed and approved the study?
- Who is sponsoring the study?
- How are the study data and subject safety being checked?
- Where will information from the study go? (For example, reports might go
to the Food and Drug Administration.)
For your own protection, be sure to get satisfactory answers to these questions
before you agree to take part.
Do You Want To Participate In A Clinical Trial?
If you are interested in participating in an upcoming clinical trial, please
call 301-405-0128 and leave
a message. Someone from our office will contact you for further information.