Clinical Trials

Clinical research is designed to help learn more about diseases and holistically improve present and future healthcare, with clinical trials at the heart of it. 

Learn why Southwest Florida Rheumatology is a proud research center and site for numerous clinical trials, and why actively participate in research.

What are clinical research trials?

The American College of Rheumatology also explains how clinical research trials serve as ways to test promising new treatments or even existing therapies, especially in the field of rheumatology.

As ACR described in the general process of these clinical trials, patients with a condition, such as rheumatoid arthritis (RA) or other related diseases, are given new medicine and then monitored very closely for side effects and any improvements on the symptoms during each follow-up.

Generally, a study could either be “controlled”, where a group of patients taking the ‘study medication’ is compared to a contrast group taking a placebo, often an inactive agent, like a sugar pill. 

It could also be “double-blind”, where neither the researchers nor the patients know which treatment is being given.

Who may participate in clinical research trials?

Participating in these trials is an exciting way of moving the field forward. It's a really good option, both for patients and science, and a great opportunity to gain more information about disease states, as well as therapies.

Although voluntary, these trials may not be for everyone. 

For patients who are looking to participate in clinical trials on new medications, or other types of trials, they may have to enter their data to answer clinical questions, or come in for extra office visits to get examined more frequently. 

If you are interested in participating in clinical research, let us know! We are actively recruiting for multiple different clinical trials across different clinical disease states in rheumatology.

Another way to get into these trials is when a patient has tried multiple different therapies, without success. 

In these cases, unless they are in a clinic site that participates in research, they may not be eligible to participate in a trial for a new drug.

This gives patients additional options to participate in a trial to see if a newer therapy would work, while still following very strict research protocols and compliance. 

At Southwest Florida Rheumatology, we are very excited to be furthering research in rheumatology this way. All of our investigators are compliant with research training and good clinical practice, thus what we have are only valid, approved trials.

How may I participate?

One way to directly participate is at an appointment in one of our offices, where we may identify a patient as an appropriate candidate for a clinical trial. When speaking with one of our expert rheumatologists, we will:

1. Let the patient know if they have the opportunity to participate in a clinical trial
2. Ask their interest in joining the trial and elaborate the objectives and details of the trial
3. Obtain the patient’s consent and finally;
4. Talk to the patient about the detailed process of enrolling them in the clinical trial

Another way of participating is simply mentioning your interest to one of our doctors or physician assistants, in case volunteers are needed for a new trial. A patient can express their interest, and we will be doing the same process in looking into whether the patient qualifies for one of our ongoing trials.

Another option is to call us to see if there may be a trial for which you are eligible. 

There could be a lot of determining factors in getting qualified, and it varies from trial to trial. 

One trial could be for rheumatoid arthritis, another trial could be for psoriatic arthritis, another trial could be related to the type of treatment a patient is taking, and another trial could be completed just based on their demographic information. 

Overall, trials are set for many different conditions and instances, but most of these are usually disease or treatment specific.

What are the benefits and risks?

The biggest motivator for patients is they are the first persons, first RA patients for example, as part of the trial to first try a new treatment. Another thing is if a patient has tried all the treatments, they can be on the list for the next best treatment, and it gives them an opportunity to enroll in a trial.

On the other hand, the American College of Rheumatology described two possible risks of participation in these clinical trials, wherein:

1. Some patients may receive placebos which may cause no change or a worsening condition
2. Participants may experience side effects from the medicines still under investigation, which doctors generally know much less about

The ACR also highlighted the final point which could either be an advantage or disadvantage depending on the patient –clinical trials need more monitoring than standard clinical care, which could mean longer and more frequent visits to the doctor compared to regular clinic visits.

What’s the process when taking part in clinical trials?

Clinical trials where patients are involved have a very strict and controlled environment. This means that there are certain things they will absolutely have to know, such as the ‘study medication’ side effects, and what to do in case the medication needs to be stopped.

There are also factors participants are not allowed to know, for example in a blind trial, whether they will be receiving Drug A or Drug B as this affects the trials.

Since clinical trials are only for trained and compliant clinics and personnel and follow strict protocols requiring prior approval before enrolling patients. 

Overall, at the end of the trial, everything is disclosed to the participants. However, only after the medication is approved by the Food and Drug Administration (FDA) can a drug be prescribed.

Are there different phases of trials?

The different phases and duration of the trials vary and are dependent on the type of trial being done. Some trials can be two years long, some trials are just data registry, some are becoming part of a registry which means one or two visits can already collect data and it’s done.  

Generally, the National Institute of Health describes these series of steps as “phases”, each having a different purpose and answering different questions. 

• Phase I trials: Tested in a small group of people (20–80) for the first time to study the drug or treatment, learn about safety, and identify side effects
• Phase II trials: Tested in a larger group of people (100–300) to determine its effectiveness and to further study its safety
• Phase III trials: Tested in large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely
• Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use

What completes a clinical trial and what’s next?

Even after the medication is approved by the FDA and made available to the public, the results of the trial are published in peer-reviewed scientific journals where experts evaluate the reports and make sure that the analysis and conclusions are solid and reliable.

As the NIH concludes, once this new approach has been proven safe and effective in a clinical trial, it may become a new standard of medical practice.

As long as new clinical trials arise, new conclusions are possible, and new treatments will always be anticipated in the future. Southwest Florida Rheumatology is proud to be one of the clinics that make these happen.