The study of pharmaceutical research means clinical trials that study medication that is not yet on the market or is being studied for new uses.

Clinical Research Studies, also referred to as Clinical Trials, are studies of investigational medicines and treatment options. These studies evaluate both the effectiveness and safety of the treatment.

Since both medical conditions and treatments are always evolving, there is a need for clinical research. Before a drug can be placed on the market, a certain amount of research and acceptable amount of effectiveness must be achieved. As a volunteer in a clinical trial, you may be participating in the development of therapy new medication that may eventually offer better treatment for specific illnesses. There are many reasons people volunteer for clinical trials including:

• To help others in the future
• To try newer and possibly better treatments for their condition
• To obtain high quality, individualized care at no cost
• To help the advancement of science

There are a number of reasons why people participate in research studies. Some do because the research can provide them access to promising drugs long before these compounds are approved for the marketplace.

It is also attractive to individuals who may not have health insurance and/or those who do not have the financial means to obtain professional care or treatment. And, finally, many patients derive satisfaction from knowing that they are part of an effort to potentially help other people who may be suffering from the same condition.

Florida Clinical Research Center, LLC was founded as CORE Research, Inc in May 1998 by Dr. Andrew J. Cutler, M.D. FLCRC is dedicated to the highest quality pharmaceutical research. Dr. Cutler is Board Certified in both Psychiatry and Internal Medicine and has been performing clinical research since 1993. The physicians at FLCRC are Board Certified in their specialty area with extensive clinical research experience.  Dr. Cutler and his skilled team of physicians, nurses, research coordinators, research assistants, and recruitment specialists, treat every patient as a significant individual.

 

Before entering into a clinical trial, it is important for you to have as much information as possible about the study, procedures and medications in order for you to make an informed decision about whether or not to participate. To assist you in this process, the study physician and research staff will review an Informed Consent Form (ICF) with you. The ICF describes all of the potential risks and benefits of the study as well as your right to voluntarily discontinue participation at any time for any reason. Click here to learn more about your experience as a participant in a clinical trial.

No, you do not need health insurance to participate in a clinical trial. Often that very fact is what attracts patients to clinical trials—studies offer a viable alternative when quite often one isn’t available due to finances or advancements in medical science.

Yes, depending on the study, it is common to receive monetary compensation for time taken to travel to the facility and for participation in the study.

 

Prescreening is done for all patients interested in enrolling in a clinical trial. Once the consent is signed a qualified physician or psychologist will perform required diagnostic assessments to verify the diagnoses before medication is administered.

 

Usually 30 minutes to one hour. However, if you are likely to be enrolled in a trial, we spend a lot of time upfront to ensure you understand every aspect of the study, and your role as a participant.

 

Length of recruitment varies for each study. A study may be enrolling for a few months to a couple of years.

 

The number varies for each study per site as well as for each study in its entirety. Some studies are conducted in the US an in other countries concurrently.

 

Lengths vary, but most last anywhere from three to eighteen months. However, some studies last only a few weeks, while other could involve several phases or arms and last for several years.

 

Sometimes an overnight stay is required as part of the study. However, 80% of the studies are done on an outpatient basis.

 

Participation is completely voluntary.

 

With administering any drug, there are risks that the study physician and research staff will review with you. Each study has an informed consent form that describes all of the potential risks and benefits of the study as well as your right to voluntarily discontinue participation at any time for any reason.

 

Once enrolled in the study, you will begin to take the study medication being evaluated. In certain studies, the medication being studied may be compared to a placebo. A placebo is an inactive substance. All of the known possible side effects of the drug are explained prior to beginning any medications. Some patients may experience side effects with the investigational drug. It is important to notify a member of the study team as soon as possible if you experience any new symptoms or worsening of your condition. The physician overseeing your care will take all necessary steps to monitor your safety. Many of our studies allow for extensive follow-up care upon completion.

 

In many studies, you and your physician may be “blinded” in that neither the physician nor the patients knows which individuals participating are receiving the drug versus the placebo. However, should your symptoms worsen during the trial; steps will be taken to monitor your safety discontinue participation if indicated.

 

A placebo is an inactive substance having no pharmacological effect but administered as a control in testing.

 

As most of our studies are placebo controlled, there is always a chance that you could be administered the placebo. The actual percentage of a possibility totally depends on the number of patients in the study (usually 10 to 25) and can be discussed further upon being enrolled in a trial.