An In-depth Look at Our Research Studies
Peer behind the curtain of clinical research.
By Ted Swing, Ph.D.
At Pain Doctor, we are committed to advancing pain medicine by taking part in research, particularly clinical trials. This is important to advancements in medical care, yet most patients are unfamiliar with the types of studies and how they’re conducted.
In order to enroll in a clinical trial, patients must generally meet certain criteria. These ensure any patients enrolled are likely to benefit from the treatment and the treatment will be safe for them. For example, many clinical trials exclude pregnant women. In pain clinical trials, patients often must have a certain type of pain, such as nerve pain, in order to enroll.
Patients are sometimes referred to me by other healthcare providers or contact me directly inquiring about a clinical trial. In other cases, I identify patients who appear to meet study criteria based on their medical records. Either way, if a patient appears to be a candidate for the study, he or she must complete the study screening. This often includes a review of the patient’s medical records, a medical history interview and blood tests and/or imaging (X-ray, MRI). Patients may not qualify to take part in a study if they do not meet certain criteria on these tests.
Phases of Research
Registered clinical trials are divided into four phases indicating how close a particular treatment is to gaining Food and Drug Administration (FDA) approval. These trials involve providing some type of treatment, as well as following up with patients for an extended period of time.
Phase one studies are conducted to test new treatments. Some involve applying a treatment in animals; others are done using human cells collected from a volunteer and then exposed to treatment conditions in the laboratory. Looking at the effects on a few cells can provide insights into how a treatment (for example, stem cells) might affect the human body when applied on a larger scale. For studies of medical devices, a phase one study may be done to ensure that the device can be safely implanted.
In the second phase, the treatment is tested on humans. To proceed to this phase, the phase one trial should have provided evidence that the treatment is viable and relatively safe. Establishing the safety of a treatment in humans can take a long time, however, as patients must often follow up for a period of months or years to ensure the treatment has not caused any serious side effects. The Mesoblast stem cell study treating low back pain is an example of a phase two study. Though recruitment has closed for that phase two study, once Mesoblast’s phase three trial begins we hope to begin recruiting again.
Phase three studies are intended to measure the effectiveness of the treatment and establish safety, therefore these studies usually include fewer patients. Once a phase three study is completed, the data are presented to the FDA. If the treatment is found to be effective, it will receive FDA approval, can be used as a standard treatment in clinics around the country, and will often be covered by insurance. Treatments patients receive in hospitals and clinics have generally gone through this phase.
Treatments may only go through the first three phases of testing, but in some cases even after a treatment has been found to be safe and effective researchers may want to study it further. In that case, a phase four study can be conducted. The Pfizer arthritis study is an example of such a study. Though celecoxib (Celebrex), naproxen (e.g., Aleve) and ibuprofen (e.g., Advil) are already approved treatments for arthritis, there is little comparative evidence of which one is safest for patients at high risk of cardiovascular health problems.
Other studies may not test new treatments at all, but instead gather data to help develop questionnaires that assess health conditions such as pain. These questionnaires are used in other research studies as well as in assessment of patients during the course of clinical treatment. For example, when assessing pain it is important to also have questions regarding how a patient is affected in other ways. Though the standard method of reporting pain from zero to 10 is useful, if a treatment enables a patient to return to work or resume his or her regular social activities, this is important to know as well. Unlike other types of medical research, surveys may not have strict inclusion criteria and may be completed over a short period of time, for example a single survey.
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 Pain Doctor since May 2012.