Do you suffer from chronic pain that isn’t responding to traditional treatments? Becoming part of a clinical trial can give you access to cutting-edge treatment options for your pain. Here’s answers to your most frequently-asked questions about our clinical trials.
What is a clinical trial?
A clinical trial is a type of study examining one or more medical treatments to evaluate their safety and effectiveness for treating a particular medical condition. Often these studies are conducted to compare patients receiving a new treatment to patients receiving no treatment, an older treatment, or a placebo (a treatment that resembles the treatment of interest, but without providing any therapeutic benefit).
The purpose of this comparison is to see if the new treatment is better than the available alternatives. Patients taking part in a study may be randomly assigned to one of these conditions and may be blinded, meaning they are not informed which condition they are receiving (though they are informed of all possible study treatments before beginning the study).
The researchers who have contact with the patient are often blinded to the patient’s assigned treatment as well; a study design referred to as a double-blinded study. These study elements (randomization, placebo control and double-blinding) allow researchers to be more confident about the differences in treatments.
When are clinical trials performed?
Many clinical trials are conducted in order to get Food & Drug Administration (FDA) approval for a new treatment. A company that developed a treatment and funds studies of it, known as a sponsor, will work with the FDA to design one or more studies and provide the FDA with updates on their progress. When the study is completed, they present the results to the FDA and may receive approval. FDA approval allows this new treatment to be widely used. Typically, insurance companies and other payers, such as Medicare, will also pay for the treatment at this point.
However, clinical research doesn’t necessarily stop just because a treatment receives FDA approval. Often the FDA will require the sponsor to continue to conduct clinical trials on the treatment to check for side effects that may have been missed in the initial research. These studies, called post-approval studies, tend to be different in that patients may not be randomized and the treatment itself may be paid for through insurance.
What are the pros and cons of taking part in a clinical trial?
Taking part in a clinical trial can be beneficial to patients in several ways. They may receive a new treatment that is potentially more effective than existing treatments. If they receive an older treatment, in many studies it is provided at no cost. Even when patients are randomized to a receive a placebo treatment, some studies use a crossover design, meaning after an initial period (e.g., three months), these patients will be switched over to the therapeutic treatment. In some studies, patients also receive payments for study visits to cover the cost of transportation as well as their time.
As with any medical treatment, there can be side effects to new treatments. In most cases these are mild and temporary, but they can be serious. Taking part in a study also requires a patient to take part in multiple visits at a clinic or other facilities. The risks and benefits should be carefully considered before a patient agrees to take part in a trial. In addition to the individual risks and benefits, taking part in a study can help advance medical science. New drugs, devices and surgical procedures must go through this process before they are available to the public.
How can I enroll in a clinical trial?
Even if a patient is interested in a study, it may not be possible for them to enroll. Each trial is looking for a specific type of patient, such as patients with moderate to severe nerve pain resulting from surgery. Interested patients must typically complete one or more visits potentially involving questionnaires, a physical examination, imaging and other screening procedures in order to determine if they are eligible for the study.
At Arizona Pain, we are committed to advancing the treatment of pain. We are currently enrolling patients in several active clinical trials. Patients who are interested in enrolling in a clinical trial can contact me or speak with their providers at Arizona Pain. You can also check back here on the blog for more details on our current studies.
Ted Swing has thirteen years of research experience in psychology and pain medicine and four years of teaching experience, has published in top psychology and medical journals, and has presented his research at major conferences. He received his Ph.D. in Social Psychology from Iowa State University and has been the Research Director at Arizona Pain since May 2012.