Research Studies

Clinical Trials and Drug Development

General outline of our involvement

When a pharmaceutical company is ready to test a new drug, it searches internationally for sites best suited for the trial. The company looks for sites with experienced and qualified staff and appropriate medical facilities. After the sites are chosen, their local or regional institutional review board will review the project to safeguard the interests of the trial subjects.
The pharmaceutical company launches the study by educating the research staff who work on the clinical research project.
Representatives of the pharmaceutical company visit the Arthritis Center to initiate the site and ensure that all regulatory documentation has been completed and processed. Sponsor personnel also review the project with the study coordinator and appropriate research staff.
When all this has been completed, recruitment for “human subjects” begins. Recruitment can happen in many ways.

Early in a study some subjects may receive placebo (an inactive therapy). This is done in comparison with the investigational treatment to see whether or not the investigational treatment is effective.
Later, the new therapy is compared with the best treatment dose available.
Finally, there are long-term extensions of the study following patients a few years to ensure the safety and effectiveness of the new medication.
The information gathered from these trials is then submitted to the FDA for approval in the United States.

Having a diverse representation of genders, races, ethnicities, ages and other factors makes the results from the clinical trials better applicable to real life. 

You will have the opportunity to have access to new groundbreaking treatments before they are available to others.

If you are interested in making a difference in arthritis care please contact our office today.

Frequently Asked Questions

Here are some frequently asked questions for the research center.

A clinical trial is a scientific investigation to see how a potential new medication or treatment will work for people who have certain types of diseases or conditions.

You may gain access to new drugs and other treatments, sometimes years before they are widely available.
You will be monitored closely for any side effects.
You will have the chance to take an active role in your own healthcare.
You will be making a valuable contribution to arthritis research.
It can provide significant cost savings to patients that may be uninsured, underinsured, or who have exacerbated other treatment options.

The treatment might not work.
The treatment might cause serious side effects.
Even if a new approach helps some patients, it might not help you.

A placebo is a pill or other substance that has no therapeutic effect. A placebo is most used when a standard treatment is available to patients, and we want to compare that standard treatment to a new treatment. If a placebo is part of the trial you are considering, you will be fully informed of that info ahead of time.

Nothing! Everything including the study drug, study visits, procedures or tests that are needs as part of the trial are free of charge.

In the past patients were never paid to participate in a trial. It is at the discretion of the Sponsor and site if patients will be reimbursed for travel. Please discuss that with the Research staff.

All clinical trials have a guideline called an eligibility criterion that will detail exactly what is required for the trial entry. Some of the criteria will include age, specific disease, treatment history, and other medical conditions.

The informed consent is how you will learn everything you need to know about the clinical trial. It will explain the purpose of the trial, description of the trial, what will happen at each visit, all potential risks and benefits, and information about the privacy of medical records.
If you decide to participate, you will sign a consent form that details all the information that was discussed with the Research team. You will get a copy of the informed consent to take with you so that you can refer to it at any time.
As the study continues, the inform consent will be updated. These updates will include any side effects or other risks that have been identified, as well as updating you on the progress of the trial.

Your full identity will not be on any of the study documents or samples taken. All personal data that directly identifies you will be removed from your study data before it is given to the Sponsor.

Taking part in a clinical trial is voluntary. You may decide not to participate, or you may leave the trial at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled to.

Contact Us! Sarasota Research Center

If you're interested in participating in a drug study, please contact us using this form. If you have any questions, please call the Sarasota Research Center at (941) 365-0770 ext 1222. If it is an emergency, please dial 911. For questions or assistance outside of our normal office hours, please call our main office in Sarasota, Florida at (941) 365-0770. For information regarding appointments or any other information, visit the locations page for location-specific numbers.

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Our Providers

Our providers, including Board Certified Rheumatologists and Advanced Practice Providers, have completed residencies and fellowships in Rheumatology and Internal Medicine. If you want to join our team, click the button below to view current job opportunities.

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