What is a clinical trial?

A clinical trial is a carefully designed study consisting of volunteer patients who receive treatment under the intense supervision of physicians and research professionals. Respected Pharmaceutical and Biotechnology companies select these highly qualified and efficient physicians and investigators. Clinical trials must take place before the medication is given out for prescription or over-the-counter use to the public.

What can I expect?

If one participates in a clinical trial, he/she is usually assigned to a specific study group. At times, a volunteer in a group may be given a placebo (inactive product used as a basis of comparison for the real drug tested) or readily available treatment. The patients and staff are purposely made unaware of this in order to keep investigations fair and accurate. Regardless of whether the volunteer receives placebo or available treatment, they are provided with the same medical care as everyone in a group.

What happens after?

After a trial is finished, the pharmaceutical company that sponsored the study will submit their findings to the Food and Drug Administration (FDA). Based on the research, the FDA will decide if the study medication can move to the next phase of testing. If approved, another trial phase will proceed consisting of different volunteer patients. This testing and re-testing of new medication will continue until all four phases of the clinical trial process are complete. After the third phase of testing is finished, the pharmaceutical companies that sponsored the clinical trials must again submit their completed findings to the FDA. At this point, the FDA makes the final decision on whether the product is safe for the public, in need of further testing, or should be totally disregarded. If the product is deemed safe and effective, the study medication moves into the fourth and final phase of clinical trials, where it is available to the public, but still monitored for safety.

Is medical insurance required?

Participation in our studies will be free of all charges. This includes all study-related procedures such as a physical exams, diagnostic laboratory tests, and the administration of the study medication.

What are the risks of a clinical trial study?

There are risks to participation in a clinical study that vary from person to person. Every effort will be made to determine any foreseeable risks before the study is conducted, but side effects and health risks may not be entirely known. A physician will carefully go over any known risks and side effects using the informed consent form during the first visit.

What are the benefits of a clinical trial study?

By conducting these trials, we are able to discover how beneficial a potential medication would be to society. The advancement of medical science through these trials is extremely beneficial to current and future generations. Additionally, all of the clinical trials sponsored at The Clinical Trial Center provide study-related care and efficient medical services. Finally, depending on the clinical study, there may also be monetary compensation for time and travel expenses.

What are the study participant's responsibilities?

Study participants are asked to fully disclose to the physician past and current medical conditions, illnesses, and medications. The study coordinator asks that all study participants follow the prescribed treatment plan and attend all scheduled visits. This is all in the interest of safety for the study volunteer.