Just the Facts

An Inside Look at the Clinical Research Process

By Ted Swing, Ph.D., and Kevin Whipps

As researchers, we are committed to leading the way in pain medicine through clinical trials. But often we’re asked how we do what we do: the process, treatments and conditions, and what those mean for our clients. So what is the clinical research process and how does it work? Let’s find out.

What are clinical trials?

Clinical trials are research studies that gather information and support conclusions about the safety and efficacy of medical treatments. Many types of treatments are studied in clinical trials, including medications, injections, medical devices and surgical procedures. Typically, clinical trials are conducted with new treatments. For example, when a new medical device such as the Bioness StimRouter is developed, its safety and efficacy must be tested in a clinical trial before doctors can order it for their patients. Though treatments in clinical trials are usually not yet approved for widespread use, the clinical trials that test their safety and efficacy must be approved and supervised by the Food and Drug Administration (FDA). Medical researchers will already have reason to believe that a treatment is effective before it reaches the point of clinical trials in actual patients. For example, they may study the effect of a new drug on individual human cells in the lab before testing it in patients.

Because clinical trials are research studies, often patients get one treatment of two or more possible treatments and may not be told which one they are receiving. This is important because it is often the only way to learn whether a new treatment is more effective than a current treatment. Patients are not told which treatment they are receiving because that could allow their expectations to influence the way they respond, which investigators want to avoid because it could bias the results of the study.

What are the benefits of taking part in clinical research?

The patients who agree to take part in a clinical trial often — though not always — have a medical condition that the clinical trial may treat. By taking part in the trial, participants may receive a treatment that is as effective as, or potentially even more effective than, the best currently available option.

Clinical trials often provide this treatment at no cost to the patient, and in some clinical trials, patients are compensated for their time or travel expenses. Patients may receive additional medical attention during a clinical trial, such as clinic visits and diagnostic tests that could identify medical problems. Patients are also making important contributions to the future of medicine. The great strides made in modern medicine depend on the patients who take part in clinical trials.

What risks and costs are involved in clinical research?

Like all medical treatments, those used in clinical trials may have side effects. These vary in type and severity depending on the specific trial, but should be considered before participating in a study.

The researchers, sponsors and the FDA carefully monitor any adverse events that occur during the course of a clinical trial. Though treatments and follow-up visits are often free in a clinical trial, patients may have to complete diagnostic tests in order to qualify for a clinical trial. The study’s sponsor may not cover the cost of these tests, though insurance will often pay for them.

Participating in a clinical trial also typically requires multiple visits related to the study for screening, treatment and follow-up. These visits may continue for years. Patients should consider their willingness to attend follow-up appointments when enrolling in a study.

How can I find out more about clinical research?

You can learn about clinical trials by contacting the investigators or clinical research coordinators. Another useful resource for identifying and learning about clinical trials is the website Clinicaltrials.gov. This is a website database provided by the U.S. National Institutes of Health of all federally and privately supported clinical trials. This website can be searched for information about clinical trials, including what conditions are being treated, who may take part in the study and where each trial is being conducted.

Ted Swing has more than eight years of research experience and four years of teaching experience in psychology, 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.