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What is a clinical trial?Why should I participate in a clinical trial?What are the risks when participating in a clinical trial?How do I find out more about clinical trials that are now enrolling?What questions should I ask before agreeing to participate in a clinical trial?Who can apply to participate in a study?What happens if I don’t qualify for the study?What happens during a clinical trial?What happens if I no longer want to participate in a trial after it has started?Where are the clinical trials conducted?Will I have to stay at the research center?How long do trials usually last?Will I be paid for participating in the trial?What is an investigator?What is the Food and Drug Administration’s Drug Review Process?How does HIPAA apply to drug studies?Where can more clinical trials be found?
What is a clinical trial? Clinical trials are studies in which people help doctors find ways to improve health and medical care. Each study tries to answer specific questions about a disease or health condition. Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population.
Why should I participate in a clinical trial? Choosing to volunteer for a clinical trial is an important personal decision. There are many reasons to participate in a clinical trial, which may include:
It is often helpful to talk to a physician, family member or friend about deciding to join a clinical trial.
What are the risks when participating in a clinical trial? There is always certain level of risk involved with research studies. However, patient safety is our top priority at KCUMB. Our dedicated staff has more than 50 years combined research experience, and is certified by the Society of Research Administrators and the Association of Clinical Research Professionals. For information about side effects on specific studies, please call 1-877-425-0250. View the benefits and risks to learn more about what questions you should ask before participating in a trial.
How do I find out more about clinical trials that are now enrolling?
You can call 1-877-425-0250 or visit Trials Now Enrolling to see a list of current trials.
What questions should I ask before agreeing to participate in a clinical trial? Our staff is here to help! If you have any questions about a specific trial, please call 1-877-425-0250 or email firstname.lastname@example.org. It is also helpful to consult your physician before participating in a trial. Below are some study-specific questions that you should ask before enrolling:
Who can apply to participate in a study? In order to participate in a trial at the Center for Community and Clinical Research, you must be at least 18 years old and legally able to make your own decisions. For your safety, you must also be able to read, understand and speak English in order to fill out the appropriate forms and communicate with the staff. Each study has its own enrollment criteria that you must fulfill prior to participating in a trial.
What happens if I don’t qualify for the study? Prior to enrolling in a study, you will be asked several questions to ensure that you qualify to participate. After completing the Volunteer Form, or after you contact the Clinical Research Center to participate, you will need to answer several questions to determine whether or not you are eligible. If you do not qualify, we will ask for permission to keep your name in our database for future trials. If you do qualify, you may be asked to participate in the next stage of a trial. Many trials have several stages, and you may be disqualified at a later stage of the trial. If the trial provides compensation, you will still be compensated for each stage that you complete.
What happens during a clinical trial? During your first visit, you will receive an information and consent form that will explain more about the study: how long it will last, what will happen during the study, who is sponsoring the study, what the risks are, and what the compensation is for each stage of the trial. If you have any additional questions at that time, you can speak with a member of our staff.
What happens if I no longer want to participate in a trial after it has started? Participating in a trial is your decision. You can decide not to be in the study at any time. If you no longer wish to participate in the trial, tell the study doctor or staff, and return all study materials. You may also be removed from the trial if the study doctor believes it best, if you do not follow directions during the trial or if the sponsor stops the trial.
Where are the clinical trials conducted? Most clinical trials are conducted on the KCUMB campus at the Center for Community and Clinical Research. Our facility offers several amenities for trial participants, such as a spacious patient lounge with wide-screen TV, full kitchen, comfortable accommodations with private bathrooms. Click here for directions or a map of the campus, or take a photo tour to see more of our facility.
Will I have to stay at the research center? Most of our trials do not require overnight stays. Participation requirements vary by study, and you should ask any study-specific questions before enrolling in a trial.
How long do trials usually last? This will vary according to trial. Prior to enrolling in a study, you should ask about the duration of the trial.
Will I be paid for participating in the trial? This will vary according to trial. Prior to enrolling in the study, you should ask if you will be compensated for your time and travel.
What is an investigator? An investigator is responsible for ensuring that an investigation (drug study) is conducted according to applicable regulations; for protecting the rights, safety and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
What is the Food and Drug Administration’s Drug Review Process? Drugs must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug, from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured. To learn more about the FDA‘s Drug Review Process, visit:http:/www.fda.gov/fdac/special/testtubetopatient/drugreview.html
How does HIPAA apply to drug studies? This link provides information about your rights as a research participant as it relates to the privacy of your medical records.http:/privacyruleandresearch.nih.gov/pdf/clin_research.pdf
Where can more clinical trials be found?ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations and phone numbers for more details. The information provided on ClinicalTrials.gov should be used in conjunction with advice from health-care professionals.
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