Clinical Trial Knowledge Center
Featured Clinical Trials
STEPS - Totalis™ Lumbar Spinal Stenosis Clinical Trial
Sponsored by: Vertiflex, Inc.
Study evaluates a minimally invasive procedure for low back spinal stenosis The STEPS Trial is a comparative research study to show how well the Totalis™ Direct Decompression System procedure works to relieve pain and other symptoms related to lumbar (low back) spinal stenosis. Lumbar spinal stenosis is a very common condition and the number one reason for spine surgery in people over 60 years old. Learn More
What is a Clinical Trial?
Clinical trials are a type of research study that uses human volunteers to see if certain medications or treatments are safe and effective. This type of research is an important tool researchers use to find ways to improve health and offer new treatment options for a wide variety of health conditions.
While there are many ways in which clinical trial studies are designed, most are either interventional studies, in which a controlled environment is used to see if experimental treatments are safe and effective; or observational, in which natural settings are used to see how therapies or treatments affect large groups of people.
Who Sponsors a Clinical Trial?
Most clinical trial studies are sponsored by pharmaceutical or biotechnology companies, medical institutions, and foundations. In some cases, a government agency such as the National Institutes of Health (NIH) provides funding for the trials.
The United States Food and Drug Administration (FDA) oversees all clinical trial studies done in the U.S. It is responsible for:
- Determining if a clinical trial is needed.
- Approves the scope and goals of the trial.
- Helps select the researchers who will run the trial.
- Reviews the results of the clinical trial.
- Determines if the new medication or device will be made available to the public.
Who Can Participate in a Clinical Trial?
In order for a clinical trial to produce reliable results, participants in the study must be carefully selected. All clinical trials have rules and guidelines about who can and cannot participate. These are called inclusion and exclusion criteria and involve such factors as age, gender, treatment history, stage of disease, and other medical conditions.
Factors that allow a person to participate in a clinical trial are called the inclusion criteria and factors that do not allow a person to participate are called exclusion criteria. Some trials look for participants who are healthy and have no previous health conditions while other studies only want participants with certain illness to participate.
Before a clinical trial can accept any participants, the sponsor of the study must clearly describe the inclusion and exclusion criteria.
It's your personal choice if you want to participate in a clinical trial. If you are unsure, talk to your doctor, family, and friends. If you find a trial that you might qualify for, contact the research staff to get more information. Knowing as much as you can about the trial will make your decision a bit easier.
Different Types of Clinical Trials
There are a variety of types of clinical trials including the following:
- Treatment trials test new treatments.
- Prevention trials look for new ways to keep people healthy or keep a disease from returning.
- Diagnostic trials look for better ways to diagnose a disease.
- Screening trials look for better ways to detect a disease.
- Quality of life trials look for better ways to improve the quality of life of people with chronic illnesses.