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Information for Patients about Clinical
Trials
Before making a decision to participate in a clinical trial, it is important
to have a basic understanding about clinical trials. The information provided
here is to help you in making an educated decision.
Frequently asked questions:
- What is a clinical trial?
- Why are clinical trials important?
- Who can participate in a clinical trial?
- Why should I participate in a clinical trial?
- What are the benefits?
- What are the risks?
- Who sponsors clinical trials?
- What is a protocol?
- What does it mean if the study is blinded?
- What is a placebo?
- Who is responsible for protecting the rights of research
participants?
- What is informed consent?
- What are the phases of clinical trials?
- What is randomization?
- Once I sign the consent, can I change my mind?
- Where can I go to find more information on clinical trials?
- What is a clinical trial?
A clinical trial is a carefully planned research study designed to evaluate
the safety and/or effectiveness of a treatment on an illness or condition
in humans. The treatment can be a medication, a device, treatment, or preventive
measures.
- Why are clinical trials important?
Clinical trials provide the information necessary to develop new treatments
and medications. In the United States, the Food and Drug Administration (FDA)
requires that new drugs or devices be tested and shown to be safe and effective
before they can be approved. Clinical trials also help to answer questions
on whether medications have side effects or are more or less effective in
certain types of patients.
- Who can participate in a clinical trial?
All clinical trials have questions the researchers are trying to answer. There
may be questions on treatment for diabetes, cancer, or questions about what
age group is most successfully treated with a certain medication. In order
to choose the appropriate people to study, each clinical trial has inclusion
and exclusion criteria that are important to answering the questions posed.
These criteria may require that participants be of a certain age, gender or
race and that they have certain medical conditions, treatment history, or
laboratory test results. By following these inclusion and exclusion criteria,
researchers are able to assure that they will be able to answer their research
questions and keep the participants safe.
- Why should I participate in a clinical trial?
The choice to participate in a clinical trial is a personal one that can only
be made by the individual and his/her family. There are many reasons that
individuals choose to take part in a clinical trial. For some, there may be
personal reasons, such as having access to medical care or a new treatment
that is not yet approved for use in the general population. Some may participate
to learn more about a disease or condition. There may be broader reasons,
such as contributing to the body of scientific knowledge to help others in
the future, or helping to gain approval for new medications or devices.
- What are the benefits?
There may be varying benefits to specific clinical trials. In general, clinical
trials provide access to new treatments before they are available. They may
provide the opportunity to obtain care from experts in the field of study.
One may learn more about a condition, as well as contributing to the body
of scientific information.
- What are the risks?
There are risks associated with taking even the most common medications. The
risks of participating in a clinical trial may be minor or life-threatening.
It is important to obtain complete information about the trial and ask questions
of the researchers to enable you as a participant to evaluate the risks and
benefits.
- What is a sponsor?
The sponsor of a clinical trial is the group which provides the funding for
the research. Sponsors can include federal agencies such as the National Institutes
of Health (NIH), Department of Veterans Affairs (VA), etc. Other sponsors
can include pharmaceutical companies, foundations, disease specific organizations,
etc.
- What is a protocol?
A protocol is the detailed plan to be followed by all conducting the clinical
trial. It specifically defines who can participate and outlines the procedures
to be done within a specified timeframe. It includes medications to be used,
length of the study, protections in place for participants, and all details
of the study. If the research questions are to be answered, it is important
that the protocol is carefully followed.
- What does it mean if the study is blinded?
Some clinical trials are designed so that the participant and/or the researchers
are not aware of the treatment assigned to each participant. This is done
when the outcome of the study can be influenced by the expectations of those
involved.
- What is a placebo?
A placebo is an inactive substance that can be one of the treatment options
in some, but not all, clinical trials. When the results of using an active
medication are compared with those of a placebo, researchers can learn more
information about the effectiveness, as well as side effects of the medication.
- Who is responsible for protecting the rights of research
participants?
The Institutional Review Board (IRB) must approve and monitor each clinical
trial and its informed consent. It is the job of this body to make sure that
the risks are minimized, that benefits are worth the risks, that the confidentiality
and rights of the participants are protected, and that the trial is ethically
conducted. This board is comprised of physicians, statisticians, community
representatives, and others who make sure that the study is conducted in an
ethical manner. After initial approval by the IRB, a clinical trial is monitored
by the IRB at regular intervals.
- What is informed consent?
Informed consent is a detailed, written document, which describes the study,
including the reason for doing the study, the procedures, the number of visits,
the treatments, risks and benefits, costs, and other options. It is required
for all clinical trials involving humans. The informed consent must be reviewed
and approved by the IRB prior to the start of the study. Prior to enrollment
in a clinical trial, each participant and/or a parent or guardian must sign
the informed consent following detailed discussion with the researchers.
- What are the phases of clinical trials?
There are 4 phases of clinical trials, each with a different purpose, different
participants, and to answer different questions. Each phase provides important
information.
- Phase I trials test a new drug or treatment for the first time
in humans in 20-100 healthy volunteers, usually in a closely supervised
environment. This phase provides information on the safety in humans,
dose range, and side effects. Phase I studies may involve significant
risk since the treatment is being studied in humans for the first time.
- Phase II trials study the treatment in larger groups (100-300)
evaluating safety and effectiveness in individuals with the disorder of
interest. Phase II studies are usually randomized and controlled.
- Phase III trials study the treatment in even larger groups (1000-3000)
to define effectiveness, side effects, safety, and comparison to other
treatments. During this phase, the treatment may be compared to a placebo
or standard treatment. Phase III studies can last for many years and enroll
thousands of patients. After data collection in Phase III trials is complete,
the sponsor may request FDA approval to license the drug or device as
a treatment for the disease under study.
- Phase IV trials are conducted after the treatment has obtained
approval by the FDA. These trials study even larger numbers of patients
to further identify risks and benefits.
- What is randomization?
Randomization is a process where study participants are assigned to one of
two or more treatment options by chance. It is thought that study results
are more valid if this process occurs to divide the differences in individuals
between all choices.
- Once I sign the consent, can I change my mind?
Your participation in a clinical trial is always voluntary. You are free to
withdraw at any time.
- Where can I go to find more information on clinical
trials?
The following web sites provide additional information and contacts on clinical
trials.
For general information:
http://www.clinicaltrials.gov
http://www.cc.nih.gov/
http://www.fda.gov/
http://www.centerwatch.com/
http://ohrp.osophs.dhhs.gov/
For specific clinical trials at Emory University
http://www.emoryhealthcare.org/clinicaltrials/clinical_trials.html
For cancer trials:
http://www.nci.nih.gov/
http://www.cancer.gov/clinical_trials/
http://oesi.nci.nih.gov/series/cted/
http://www.va.gov/cancer/
http://www.fda.gov/oashi/cancer/cancer.html
http://www.cancer.org/
http://cancernet.nci.nih.gov/
http://www.cancerguide.org/
For vision trials:
http://www.nei.nih.gov/resources/
For mental health trials:
http://www.nimh.nih.gov/studies/clinres.cfm
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