What are clinical studies?
Clinical studies are scientific research studies on human volunteers performed to evaluate the effectiveness and safety of new drugs before they are submitted to the FDA for approval. By performing clinical studies with human volunteers, research physicians find new and better ways to prevent and diagnose medical problems.
Typically, volunteers receive the drug under consideration, and biological samples such as blood or urine are collected at carefully prescribed and monitored times. It is very important to control the environment in order to achieve accurate results. Most studies involve periods in which volunteers stay in our facility from a few hours to several days.
Volunteers are compensated for their time while participating in our studies. Compensation depends on the complexity and duration of the study and is subject to state and federal taxes.
Who can volunteer for a clinical study?
If you are healthy male or female age 18 or older, you may qualify to participate in a study. In order to participate, you may be required to go through a series of basic screening procedures to evaluate if you meet the individual study requirements. If you qualify based on the results of these screening procedures, you may be included and compensated for the time that you spend in a study.
You are not eligible for most clinical studies if:
- You use illegal drugs or drink/smoke heavily
- You are on regular medication; a study physician must approve the medication for you to be eligible to participate in a particular study
- You or your partner are trying to become pregnant, are pregnant, have recently given birth or are breast-feeding
How can I enroll in a clinical study?
If you are interested in participating in a study, please contact us at 877.298.9071 or fill out our CLICK HERE for additional information. Our study coordinators will answer any questions you may have and schedule an appointment for you to visit our research facility to determine if you are eligible to enroll in a study.
Is it safe to participate in a clinical study?
There are risks in taking any medication, including those prescribed by your physician, as well as non-prescription or over-the-counter medication. The known risks of the medication being tested in a clinical study will be explained to you in a consent form and by our research physician before you decide if you wish to enroll in the study. We closely monitor for any side effects and minimize risks by carefully screening all volunteers to ensure they meet the study enrollment criteria.
Do volunteers stay overnight at the clinical research facility?
Yes. Many studies involve staying at Frontage’s Clinical Research Centers for one or more nights over one or more visits. For example, a group of volunteers may check into the Clinical Research Center on a Friday evening and go home on Sunday morning on one or more consecutive weekends. Some studies, particularly studies in patients with medical conditions, do not involve overnight stays, but rather involve brief outpatient visits.
Why must volunteers stay overnight?
It is important for study procedures and activities to be as consistent as possible in all research volunteers. This includes the same food, same general level of activity and sleep times, same medication dosing conditions and similar overall study conditions for each clinical study.
What is it like at Frontage’s Clinical Research Center?
The Frontage Clinical Research Center is a clean, modern, and comfortable facility located within 20 miles of New York City in Secaucus, NJ. It is easily accessible by car, train or bus. There are 160 beds that are arranged in different areas of the facility, which can be further divided for additional privacy. There are areas within the research facility for socializing, playing games, watching television, relaxing or reading. The Frontage staff is highly qualified, experienced and friendly and treats all volunteers with respect and compassion.
Are there things to do during a clinical study?
Volunteers may use our recreational areas to play cards and video games, read, work, relax, and watch satellite TV. Volunteers are encouraged to bring things from home that they could play (such as video games) or keep occupied with while they are at the research facility.
Are volunteers allowed visitors?
Because of our need to control the study environment, we cannot allow visitors at the research facility.
Can volunteers make phone calls while at the research facility?
Yes, volunteers may bring cellular phones to make calls as permitted by staff.
What do volunteers eat while at the research facility?
All meals are provided while volunteers are at the research facility during overnight stays and during extended day stays. Research studies usually allow for three meals (breakfast, lunch and dinner) and an evening snack depending upon study requirements. Volunteers are not permitted to bring their own food or to eat any food that we don’t serve.
What if a volunteer has a reaction or side effect to a study medication?
If a volunteer has a reaction or side effect, he/she will be monitored and cared for by qualified medical professionals.
Can a volunteer withdraw from a research study once it starts?
Yes. All volunteers are free to withdraw from a study at any time and for any reason.
When do volunteers receive their compensation?
Volunteers receive their compensation at the conclusion of study after all study procedures are completed within 5 business days of the last study visit.
If a volunteer participated in a previous clinical research study, can he/she participate in future studies?
Yes, however, there is a limit to how often volunteers can participate in clinical research studies, which has been established for safety reasons.