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. . . dedicated to RESEARCH
The Spine Education and Research Institute along in conjunction with the Center for Spinal Disorders, is proud to participate in numerous clinical research trials.
WHAT SHOULD YOU CONSIDER BEFORE PARTICIPATING IN A TRIAL?
Patients should know as much as possible about the clinical trial and feel comfortable asking the members of the research team questions about it, the care expected while in the trial, and the cost of the trial. The following questions might be helpful for the particiant to discuss with the research team:
1. What is the purpose of the study?
2. Who is going to be in the study?
3. Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
4. What kinds of tests and treatments are involved?
5. How do the possible risks, side effects, and benefits in the study compare with my current treatment?
6. How might this trial affect my daily life?
7. How long will the trial last?
8. Will hospitilization be required?
9. Who will pay for the treatment?
10. Will I be reimbursed for other expenses?
11. What type of long-term follow up care is part of this study?
12. How will I know that the treatment is working? Will results of the trials be provided to me?
13. Who will be in charge of my care?
WHAT ARE THE DIFFERENT TYPES OF CLINICAL TRIALS?
Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
WHAT ARE THE PHASES OF CLINICAL TRIALS?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.
In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drugs, treatments risks, benefits, and optimal use.
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Research 
