What are clinical trials?
How do I know if I'm eligible for a clinical trial?
How is the safety of the participant protected?
Can PMC perform research on a patient without their knowledge and/or consent?
What is informed consent?
Can I withdraw from a study?
How can I find clinical trials that may benefit myself or my loved ones?
How do I know if a trial is right for me?
Why does Pikeville Medical Center offer Clinical Trials?
If PMC cannot offer a particular study, are there other means to receive the same treatment?
Are clinical trials a "last resort" for patients?
What are clinical trials?
Clinical trials are health-related research studies in human beings that follow a pre-defined protocol.
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How do I know if I'm eligible for a clinical trial?
Call our research office or talk to one of our physicians about it.
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How is the safety of the participant protected?
Most
clinical research is federally regulated with built in safeguards to
protect the participants. As a participant in offering clinical trials
to our patients, Pikeville Medical Center is required to follow trial
guidelines and may be audited by the organization sponsoring the trial
at any time for conformance to the trial guidelines.
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. 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. All institutions that conduct or support
biomedical research involving people must, by federal regulation, have
an IRB that initially approves and periodically reviews the research.
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Can PMC perform research on a patient without their knowledge and/or consent?
Absolutely not. Including a patient in a clinical trial without informed consent is strictly forbidden.
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What is informed consent?
Informed
consent is the process of learning the key facts about a clinical trial
before deciding whether or not to participate. It is also a continuing
process throughout the study to provide information for participants. To
help someone decide whether or not to participate, the doctors and
nurses involved in the trial explain the details of the study. Then the research team provides an informed consent
document that includes details about the study, such as its purpose,
duration, required procedures, and key contacts. Risks and potential
benefits are explained in the informed consent document. The participant
then decides whether or not to sign the document. Informed consent is
not a contract, and the participant may withdraw from the trial at any
time.
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Can I withdraw from a study?
Yes.
Participants in clinical trials may withdraw at any time, for any
reason. However, when one withdraws, it is extremely helpful if the
participant can communicate why they are conducting the study to their
physician and/or research coordinator.
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How can I find clinical trials that may benefit myself or my loved ones?
1.
Contact our research coordinators at Pikeville Medical Center - Our
research coordinators are experienced medical professionals that are
very knowledgeable in their field of expertise.
2. Visit our current trials page.
Our trials page will give you the basics on what trials are currently
available and more technical information is available for medical
professionals.
How do I know if a trial is right for me?
First
of all, in order to participate in a clinical trial, the participant
must meet the inclusion/exclusion criteria. One quick way start determining eligibility is to contact
the research offices listed on the main clinical trials page.
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Why does Pikeville Medical Center offer Clinical Trials?
By opening clinical trials to our patients and providing
them with easy access to search for available clinical trials, we can
offer our patients opportunities to be treated with promising new
treatments not normally available to people in our region. In addition
to possible immediate benefits, participation benefits future patients
both here, and across the globe, by providing the kinds of information
that leads to safer and more effective drugs and treatments and leads to
longer, healthier lives.
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If PMC cannot offer a particular study, are there other means to receive the same treatment?
Yes
and no. It depends on if the medication and/or treatment has received
full FDA approval. In many cases, your doctor may feel that the
potential benefit of receiving FDA approved medications and/or treatment
methods currently in clinical trials are in your best interest. That is
a decision and an option that you can discuss with your physician.
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Are clinical trials a "last resort" for patients?
Not
at all. In most cases, clinical trials are based on nationally
accepted standards of care, such as those published by organizations
like the National Comprehensive Cancer Network.
Clinical trials are most commonly performed with patients that are
already receiving care based on those standards but may include
additional therapies or medications in addition to those already being
received.
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For a more in-depth understanding of clinical trials, please see: http://clinicaltrials.gov/ct2/info/understand
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