At any given time, there are dozens of clinical trials in progress to
determine how safe and how effective new treatments may be. Clinical trials
can last anywhere from a few weeks to many years, and they are conducted
by physicians. Participating in a clinical
trial is completely voluntary, but it isn't for everyone. We encourage
you to talk with your rheumatologist about any specific clinical trials,
what to expect, and how to find out about clinical trials that might be
right for you.
Fast Facts
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Clinical trials test new and promising treatments.
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Before participating in a clinical trial, understand
its risks and benefits.
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The best way to find out about a clinical trial is to ask your rheumatologist
What is a clinical trial?
Doctors use a variety of different medications to treat patients who
have arthritis and other rheumatic diseases and many new treatments are
in development. Before any medicine can be prescribed or used,
the federal Food and Drug Administration (FDA) requires that the drug
undergoes strict testing to be sure that it will be safe for people to
take and effective at treating a particular disease. This process of testing
and evaluation is conducted mainly through clinical trials.
A clinical trial is a research study performed by physicians and other
health professionals in which new treatments are tested in volunteers.
These studies take place only after laboratory investigations indicate
that the new treatment has potential. Any institution sponsoring the study
(be it a university, hospital, or other healthcare facility) must also
have in place an institutional review board (IRB) that determines whether
a proposed study can be conducted safely, and then oversees the study
to ensure that all federal regulations that protect human volunteers are
being followed.
While participating in such a study, patients with a particular condition
(such as rheumatoid arthritis)
are given a new medicine and then followed very closely. During follow-up,
the study personnel assess the safety of the new medicine and evaluate
how well it helps control symptoms. In order to accurately determine how
safe and effective a new medicine is, the study medication is compared
to another medication or to a placebo (an inactive agent, like a sugar
pill). Many studies are ‘blinded,' meaning
that neither the study personnel nor the patients know for sure which
treatment is being given.
What information will be provided?
Participating in a clinical trial differs in several respects from receiving
treatment through regular office visits. First, before patients participate
in a trial, they must provide “informed consent.” This is required by
the federal government to make sure that patients are given detailed information
about the new medicine under investigation, such as possible risks associated
with the study medicine, possible improvements in symptoms, and alternative
types of treatments available if the patient decides not to enroll in
the trial. Patients are provided with an opportunity to read information
about the study and discuss any questions with the study staff. If willing
to participate, the patient signs the informed consent document.
Second, although doctors provide information about possible risks and benefits
of treatments when they see patients during regular office visits, the information
provided as part of a clinical trial is much more detailed. In particular,
the list of possible side effects for a medicine being tested in a clinical
trial will often be much longer than for a medicine that is already FDA
approved, or all the risks of the new medication may not yet be known. This
does not mean that the medication under investigation is necessarily more
dangerous. Instead, this type of detailed disclosure of all possible risks
is meant to ensure that patients are fully informed before they decide to
participate.
Is participation voluntary?
Participation in any research study is entirely voluntary. Only patients
who have read all of the information and decide to participate on their
own are enrolled in clinical trials. Even after enrolling, patients can
leave the clinical trial at any time
and for any reason.
Leaving the study will not affect their normal medical care in any way
What are the benefits and risks of participation?
Benefits of participating in a clinical trial include:
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Access to new and potentially more effective medicines
before they become available to the general public.
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In many clinical trials, the medicine being evaluated,
doctor visits, physical examinations, laboratory tests, and other
tests are provided free of charge.
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Participating in a clinical trial advances medical knowledge
and helps future patients by enabling doctors to know the best treatments
for particular conditions, including arthritis.
Possible risks of participation include:
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Because some patients may receive placebos (inactive agents
sometimes referred to as “sugar pills”) during the study, participants
may not receive active medication and their condition could get
worse.
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Participants may experience side effects from the study
medication. While any medicine can cause side effects, doctors generally
know much less about medicines still under investigation.
It is important to remember that patients can leave a study at any time,
for any reason, including intolerable side effects or if their condition
gets worse or is not improving. Moreover, many studies in rheumatology
now include some provision for providing treatment to patients if their
condition does not improve, even before the study ends.
A final point to consider—which may be a risk or benefit, depending on your
perspective—is that because clinical trials are much more rigorous than
standard clinical practice, visits to the doctor tend to be longer and more
frequent than regular clinic visits.
How do I know if a clinical trial is right for me?
Clinical trials are limited not only to a particular condition, such
as rheumatoid arthritis (RA),
but also to people who meet carefully defined criteria. For example, some
trials are for RA patients who are taking the medication methotrexate (Rheumatrex),
whereas other trials may exclude patients taking this medication. In order
to accurately assess whether a new medication is effective in helping
arthritis, many studies enroll only patients who have a certain level
of disease activity (e.g., counting the number of joints affected, looking
at lab test results, and asking you specific questions). Clinical trials
may also exclude some patients who have co-occurring illnesses that might
adversely affect health and interfere with an objective assessment of
the study medicine's safety.
How can I find out about clinical trials?
The best way to find out about clinical trials in rheumatology is to ask your rheumatologist, who can answer your questions and refer you to appropriate trials.
Points to Remember
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The safety and efficacy of new treatments are determined by clinical
trials.
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Participation in a clinical trial is entirely voluntary and depends
on an understanding of the possible benefits and risks associated with
participating in a particular trial.
To find a rheumatologist
For more information about rheumatologists, click
here.
For a listing of rheumatologists in your area, click
here.
For more information
The American College of Rheumatology has compiled a
list of clinical trial sites to give you a starting point for your own additional research.
The ACR does not endorse or maintain these Web sites, and is not responsible
for any information or claims provided on them. It is always best to talk
with your rheumatologist for more information and before making any decisions
about your care.
Updated May 2004
Written by Arthur Kavanaugh and reviewed by the American
College of Rheumatology Communications and Marketing Committee.
