Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. You may have seen notices for clinical trials on Main Line Spine’s website led by some of our medical doctors. What is clinical research, and is it right for you?
What Are Clinical Trials and Why Would Someone Want to Take Part?
Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to an already available one.
People take part in clinical trials for many reasons. Healthy volunteers say they take part to help others and to contribute to moving science forward. People with an illness or disease also take part to help others and possibly receive the newest treatment and have added (or extra) care and attention from the clinical trial staff. Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future.
Every drug, device, tool, diagnostic test, technique, and technology used in medicine today was once tested by volunteers who participated in clinical research studies.
What Are the Types of Clinical Research?
There are two main kinds of clinical research – observational studies and clinical trials.
Observational studies aim to identify and analyze patterns in medical data or biological samples, such as tissue or blood provided by study participants. Clinical trials, also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures, and tools — in living people.
Clinical research studies need people of every age, health status, race, gender, ethnicity, and cultural background to participate. This increases the chances that scientists and clinicians will develop treatments and procedures that are likely safe and work well for everyone. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies are safety concerns.
Both healthy people and those with diagnosed medical conditions can participate in clinical research. Participation is always completely voluntary, and participants can leave a study anytime for any reason.
Is It Safe to Participate in Clinical Research?
There are several steps in place to make sure clinical research is safe. First, it is regulated by the federal government. In addition, an institutional review board (IRB) and Human Subjects Research Protection Program for each study has many safeguards built into each study to protect the safety and privacy of participants.
Clinical researchers are required by law to follow the safety rules outlined by each study’s protocol. A protocol is a detailed plan of what researchers will do during the study.
In the U.S., every study’s IRB must approve all clinical research. IRB members also review plans for all clinical studies. And they ensure that research participants are protected from as much risk as possible.
Clinical Research at Main Line Spine
Main Line Spine maintains its own clinical research center. We focused on advancing impactful clinical research related to our Physical Medicine and Rehabilitation practice through quality operations. Our center has a dedicated coordinator, and Main Line Spine’s clinical staff members serve as principal investigators for individual trials.
The Food and Drug Administration (FDA) maintains an in-depth guide to the conduct of clinical studies. You can browse this resource at: clinicaltrials.gov.
Click HERE to learn more about Main Line Spine’s clinical research center and current clinical trials.