If you’ve experienced limited success with treatment for rheumatoid arthritis or systemic lupus erythematosus (also known as SLE or lupus), you may be interested in enrolling in one of Valerius Medical Group & Research Center’s clinical trials to gain access to new treatments.
While participation in a clinical trial is usually beneficial for both you and us, it’s important that you fully understand the process before starting a trial. Below are the basics you need to know.
Clinical research is one of the final steps in getting approval from the U.S. Food and Drug Administration for a particular use of a drug. Trials may be for completely new drugs that haven’t been used before or for an older drug that already is used to treat a different symptom or disorder.
Clinical research allows doctors to carefully measure any side effects a drug may have on patients with a specific condition as well as to understand how effective it is before it’s released for general use. Some clinical research is conducted to further understand the effects of a drug that’s already FDA approved — to help decide which of multiple treatments is most effective for particular presentations of diseases.
In general, clinical research allows doctors to thoroughly test and better understand a particular drug, which can lead to better treatment for you and future patients.
To participate in a clinical trial, you must apply and pass some qualifying exams. The application process usually involves listening to a description of the study and filling out forms that indicate your interest in and your understanding of the study.
The qualification process is often more involved. Because each study focuses on specific aspects of a treatment, it’s important to find participants who meet research criteria. For instance, some trials seek patients in a certain age range or of a certain gender. Applicants also undergo a full physical to determine if they’re healthy enough to participate in the trial.
All drugs go through intensive development and are rigorously tested for safety before they reach the clinical trial stage, and the trial itself must be approved by a review board before it can be offered to patients. However, every drug has potential side effects. Before you begin your trial, you’re informed of the specific risks the research entails.
You’re asked to sign an informed consent form; however, this is not a contract binding you to participate in the study. If you believe the study is negatively affecting you, you have the right to withdraw.
Additionally, the ongoing results of clinical research projects are frequently evaluated to help ensure your safety. If a trial shows a treatment is ineffective or is harming patients, researchers can end the study early.
Clinical trials are often sought out by patients who have tried most of the current treatments available on the market for their condition and have not found relief. One of the benefits to you as a participant is access to currently unavailable and often cutting-edge treatment methods.
Another common benefit is receiving treatment for a reduced cost, as many clinical trials receive public or private funding. Your cost in a clinical trial varies because you may still need or want to maintain standard treatment for your disorder while you are taking part in the trial.
Before you begin a trial, you should thoroughly understand what costs are covered by the trial, what your insurance covers, and what costs, if any, you pay out of pocket. Most people find that participation in a clinical trial is significantly less expensive than treatment with an already approved medication.
If you are interested in joining one of our current projects — we are offering clinical trials on lupus and rheumatoid arthritis — or learning about future trials, contact Michelle Pratt, our director of clinical research, at 562-794-9801.