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CLINICAL TRIALS 101: WHAT YOU SHOULD KNOW BEFORE YOU PAY IT FORWARD IN SPINAL HEALTH CARE

As the Director of Research for the Spinal Research Foundation, a national non-profit 501 (c) (3), I lead the organization to focus on three aspects of patient care; research, education, and patient advocacy. Regarding the research, we perform both prospective and retrospective studies.  Retrospective research means we look back at the procedures that we have performed to see how it has affected people. Whereas, prospective studies mean that someone with a specific disorder of the spine is exposed to a medication or intervention and the outcomes are assessed in terms of the safety and efficacy of the treatment.  Prospective studies are considered the most unbiased of all types of clinical research.

WHAT IS A CLINICAL TRIAL?

Clinical trials are essentially tests of new drugs or interventions to see if they are safe and if they are helpful in treating spinal disease.  Research is extremely important to validate our current interventions and ensure that patients are receiving the safest and most effective treatment. Research also advances the future of medicine, meaning that many of our studies will assess the safety and efficacy of different interventions that are not yet proven. At the Spinal Research Foundation we firmly believe that our studies will improve spinal health care for generations to come.

HOW DOES A CLINICAL TRIAL WORK?

Our researchers at the Spinal Research Foundation have devised investigational questions and have developed study plans or protocols. A protocol outlines the type of patients who may participate based upon their specific symptoms and imaging findings. It also outlines the testing procedures, medications, and follow-up.  In general, once someone has enrolled in a specific study, our monitors at the Spinal Research Foundation will be sure that you are filling out questionnaires and having x-rays performed at preset time periods.

It’s important to understand that participation in clinical trials is not completely open. Each of the study volunteers must meet certain criteria based on age, gender, and health status, as well as the extent of their spinal disease. The more selective the entry criteria, the more valuable the research becomes.

In general, many of our patients are asking about our clinical trials as a means to gaining access to new medications or interventions that have not yet reached the mainstream.  Most of our protocols are actually directed toward regenerative therapies for the spine including injections into the discs and facet joints to try to retard the degenerative process or improve the biomechanics of the spine.

WHAT ARE THE RISKS AND BENEFITS ASSOCIATED WITH CLINICAL TRIALS?

Depending on each study, the risks and benefits will often differ. There is a very careful and thorough analysis of the risks and benefits in the consent form, which each participant is asked to sign.  All of our research is overseen by an institutional review board, which is designed to coordinate investigators and patients in an attempt to ensure the safety of all of the patients undergoing medical research.

QUESTIONS TO ASK PRIOR TO ENGAGING IN A CLINICAL TRIAL:

1.         What is the study trying to prove?

2.         How many patients will be enrolled in the study?

3.         What examinations, tests, and treatments will I have?

4.         How do the possible side effects, risks, and benefits of the study treatment compare with my current treatment plan?

5.         How long will the study last?

6.         Who will pay for the treatment and other associated expenses?

If you are interested in finding out more information about clinical trail opportunities or would like to see more about the current research the Spinal Research Foundation has underway visit spinerf.org.

 

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