What is clinical research?
It is “a branch of healthcare science that determines the safety and effectiveness of medications, products and treatment regimens intended for human use”.
We currently are conducting trials to evaluate new modalities in Rheumatoid Arthritis, Sjogren’s Syndrome, Psoriatic Arthritis and Gout. We do this because our providers are committed to learning of new and superior modalities for patients, providing excellent patient care and being up to date on many new innovations in Rheumatology.
We have found that clinical trials are a safe and effective option for many patients. They allow additional treatment opportunities for patients who have tried multiple medications that are on the market but have found them to be ineffective.
Trials also allow treatment opportunities for patients who are uninsured or who have difficulty obtaining available medications, due to cost or other barriers.
What to expect?
All of our trial visits are conducted at our office, where patients are normally seen. Our study visits are typically longer than a routine office visit, but they involve multiple procedures to ensure patient safety, such as patient reported questionnaires, joint counts, lab draws, ECG’s and a visit with the provider. Each study is unique in its design, but all are handled with the utmost care for our patients.
We start every trial with an informed consent process, which informs each patient of the study specific procedures, medication information, possible side effects, and overall expectations of participation.
We then follow the study specific schedule of events, which outlines when each visit occurs and what procedures take place at each visit. During these visits, every patient works very closely with the clinical research coordinators, who assist the providers in maintaining patient safety and overall compliance with the trial.
When a trial is complete or a patient withdraws, we then evaluate what the best next steps are for each individual patient.
Why clinical research is important
The FDA requires that a medication be tested before it is approved for the public to use. Therefore, clinical research is essential to the development of new and effective treatments.
In order for clinical trials to occur, willing participants are vital. Without patients in these trials, there would be no knowledge of how a medication effects the human body or specific disease criteria. That is why your participation matters!
By being a part of clinical research, you can assist in the approval of a new medications, all while receiving closely supervised medical care at no cost to you.
Remember: your safety is always our largest concern! We only want to see your health benefit. Clinical trials are not designed to harm patients. There are many laws and regulations surrounding this, which assists in your care.
In addition, our providers constantly have your safety in mind, and will not make treatment decisions that disregard this.