What are clinical trials?
Clinical trials are health-related research studies in human beings that follow a pre-defined protocol.
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.
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.
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.
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.
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.
How can I find clinical trials that may benefit myself or my loved ones?
Contact our research coordinators at Pikeville Medical Center – Our research coordinators are experienced medical professionals that are very knowledgeable in their field of expertise.
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.
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.
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.
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.
For a more in-depth understanding of clinical trials, please see: http://clinicaltrials.gov/
