Clinical Trials

Clinical trials are research studies that seek to improve and advance medical care. There are many types of clinical trials such as those studying new pain medications, diagnostic tools, and spinal implants.

The United States Food and Drug Administration (FDA) is responsible for regulating clinical trials. Different organizations and individuals sponsor, or fund clinical trials. These include doctors, medical institutions, federal agencies, and companies (implant manufacturers, pharmaceutical firms, and others).

Clinical trials follow a study plan or protocol. Think of a protocol as the rules of the clinical trial. A protocol can include information about how the study is conducted, its location, participant eligibility, how often participants are evaluated, and the duration of study. The protocol is followed closely to help ensure participant safety and so study results can be accurately reported.

For spine patients who have exhausted current treatments, a clinical trial may be an option to consider. While a clinical trial can give a patient early access to a treatment, it does not guarantee a successful outcome. If you are considering participating in a clinical trial, discuss it carefully with your spine specialist.