Clinical Trials-What to expect
If you are a little unsure of what participating in a clinical trial is or who can participate, check out this short general video.
What is a clinical study?
Researchers conduct clinical studies to test the effect of a particular medicine. The most commonly performed clinical studies at WVU CPRC evaluate investigational drugs made by generic companies and compare them to other similar products on the market and approved by the U.S. Food and Drug Administration (FDA). Investigational simply means that the drug needs to be tested and is not an FDA approved drug.
What is the result of a study?
These studies in healthy volunteers will help determine how the body breaks down the drug, to measure the amount of drug in the blood, and to see how long the body retains the drug with or without food (typically breakfast) consumption.
Why participate?
Participation in research studies not only benefits the community, it also benefits you. Participating in a study allows you to receive a physical examination and laboratory tests. Another benefit in participating is the chance to contribute to a scientific investigation that may help others. Your participation helps our community through medical research contribution.
What is screening?
The screening procedure is our way of finding out if you are eligible to participate in the research study. The screening procedure could take approximately one and a half hours, so please allow yourself extra time in case it is needed. Depending on the results, you may be required to have a follow up visit with the doctor. The screening procedures most often include blood/urine collection, vital signs (blood pressure, heart rate, breathing rate, and temperature), and ECG (painless recording of electrical activity of your heart). Medical history is completed to help the doctor determine if you are eligible to participate.
What is meant by healthy participants?
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Healthy males and females age 18 or older
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Normal physical exam and laboratory findings
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No other investigational drug study participation within the past 30 days
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No diseases of body system, for example: diabetes, heart disease and high blood pressure
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Not currently taking any prescription or over the-counter medications
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Someone who can avoid vigorous exercise during the study
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Someone who will not change their diet or exercise habits during the study
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No history of difficulty swallowing tablets or capsules
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No history of drug or alcohol abuse with negative urine drug screen
- Someone who falls within specific BMI ranges. Calculate your BMI here: BMI Calculator
How do I know if my BMI is within the specific range?
Each study could require a specific BMI range which will be explained to you upon speaking to our recruiting staff. Although they are unable to calculate BMI for you over the phone, we recommend calculating your own BMI using the following BMI Calculator. Should you not fall within these designated weight and Body Mass Index (BMI) ranges, it is possible that you will not pass the screening process to enter the study.
How long do the studies typically last?
On average, our studies have approximately two 39-51 hour in-house stays or as required by protocol. Some studies may be conducted on an outpatient basis.
What happens when I stay at the facility overnight?
You will be continually monitored by qualified medical staff for a variety of study parameters. You are permitted to bring personal items such as books, tablets, laptop and games to help you pass the time. Outlets for DVD players are provided and flat screen TVs are also available for viewing. Wireless internet is available. All meals are provided.
Can I make telephone calls during the study?
Yes, you may use your cell phone except during study procedures (blood collections, vital signs, etc.) or while in the bunkrooms.
What if I want to leave the study before completion?
The participant has the right to leave the study at any point. If you decide to withdraw, proper clinical and medical exams will be applied to assure your safe exit from the study.
Will I be compensated for participating?
WVU CPRC does pay participants who successfully complete a study. The amount per study does vary and will be outlined in the study-specific informed consent. Compensation amounts are dependent on the number of visits, blood draws and overnight stays. Once the study is complete and you have finished all required paperwork/tests, payment will be processed. Read more about payment information by clicking here.
What about confidentiality?
Records of the study and participant information are only available to the WVU CPRC staff unless law ordered. WVU CPRC staff members that will have access to your study records include: the study doctor, the WVU CPRC staff, the sponsor company and the FDA. Your personal information will not be released should any results of our research be presented in scientific meetings or printed in medical journals.
