F.A.Q.s

What kinds of research do the investigators at the RSCICDV conduct?

Current areas of investigation involve multicenter studies examining recovery of upper and lower extremity strength and function, and the development of international standards to measure improvements in walking. For example, the RSCICDV is one of only five centers nationwide participating in a study utilizing body weight-supported ambulation therapy funded by the National Institutes of Health. The RSCICDV is very involved in a number of multicenter drug trials and other therapeutic interventions as well.


How productive has the RSCICDV been?

The RSCICDV is committed to continuing its research efforts and contributing to new scientific knowledge on the advances of care and treatment in spinal cord injury. During the past five years, the Centerís researchers have published more than 150 peer reviewed original articles, books and book chapters.


Does the RSCICDV collaborate on research with other spinal cord injury centers?

Yes. As a Model SCI Center, the RSCICDV serves as lead Center or participates with other Model Centers across the country in a number of collaborative research projects. The RSCICDV also participates in the collection and storage of training and educational materials for spinal cord injury. This information can be found on the Model Spinal Cord Injury System (MSCIS) Dissemination Center website at http://www.mscisdisseminationcenter.org


Who funds the RSCICDV Research?

Studies are supported by Federal agencies, such as the National Institute of Disability and Rehabilitation Research (NIDRR) and the National Institutes of Health (NIH), drug companies and private philanthropy. A Research and Education fund has been established to support educational opportunities for the Centerís staff members, residents and students including a visiting lecture series of both national and international visiting professors, and to provide seed money for research. We welcome contributions to this fund and can be directed to:

The RSCICDV
132 S. 10th Street, Suite 375
Philadelphia, PA 19107
215-955-6579
Fax 215-955-5152


What happens during a clinical trial?

Every clinical trial is different and has its protocol (description of the study), with its own set of research objectives, inclusion/exclusion criteria, and team of investigators. However, all clinical trials are subject to the same stringent rules and regulations that govern research that involves humans. Prior to the start of the project, the proposal has been reviewed by various committees within the institution, including the Institutional Review Board, a interdisciplinary committee which evaluates all research to be sure that it meets the highest medical, as well as moral, ethical standards.

There are many different types of clinical trials, such as treatment trials (which might evaluate new drugs, or new approaches to surgery therapy), prevention trials (which look for better ways to prevent disease), diagnostic trials (to find better tests to diagnose illness), screening trials (to better screen for health conditions), and quality-of-life trials (which investigate ways to improve the life of persons with a chronic illness).

What are the phases of clinical trials?
There are usually four phases in the clinical trials process, each with a specific purpose and to help researchers answer certain questions:

  • In a Phase I trial, investigators 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.
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  • In a Phase II trial, 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.
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  • In a Phase III trial, 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.
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  • Even after a drug has been released to the general public, additional studies continue as Phase IV trials. These post-marketing studies help to gather additional information including the drug's risks, benefits, and optimal use.

  • If I participate in a clinical trial, who communicates with my primary care physician?

    During the course of the clinical trial, you will maintain your relationship with your primary care and other personal physicans. However, our researchers will work with primary care physicians to communicate the Centerís involvement with their patient and to inform them of the patientís progress. They work with community physicians to ensure that the patientís overall health is maintained and that other medications or treatments are not in conflict with the trial protocol.

    You should be aware that your relationship with the research physician bears certain differences from your relationship with your personal physician. Your personal physician individualizes the treatment of your specific problem with the expectation of a benefit to you. The research physician treats all subjects under a specific protocol to obtain generalizable knowledge and on the premise that you may or may not benefit from your participation in the study. Be sure to ask questions of the study physician if you want further clarification of this relationship.

    Why should I participate in a research project?

    Every person who participates in clinical research not only helps other people with the same condition, but also benefits the community. The information and help provided may lead to the development of new treatments or even to a way to prevent disease or the long-term affects of certain conditions, such as spinal cord injury.


    What kinds of questions should I ask before participating in a clinical trial?

    Before agreeing to participate in a clinical trial, you should feel as informed and as comfortable as possible. Here are some questions you can ask the research team that may help you to make an informed decision:

    • What is the purpose of the study?
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    • What kinds of people are you including in this study?
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    • Why do you think this new treatment may be effective?
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    • Has it been tested before?
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    • How many people received this treatment before?
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    • What kinds of tests and treatments do I need to receive?
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    • How do the possible risks, side effects, and benefits in this study?
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    • How does this treatment compare with standard treatment?
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    • How might this trial affect my daily life?
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    • How long will the trial last?
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    • How often will I be required to return to the hospital or to a doctorís office?
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    • Will hospitalization be required?
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    • Who will pay for the treatment?
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    • Will I be reimbursed for other expenses?
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    • What type of long-term follow up care is part of this study?
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    • In this study, is there a possibility that I will receive a placebo (sugar pill) or a fake treatment and not receive a real treatment at all?
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    • If not, how will I know that the treatment is working?
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    • Will I receive some notice about the results of this study?
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    • If I participate, who is considered "my doctor"? If I get sick, who do I call?
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    • If I get sick and I donít think it has anything to do with this study, who do I call?

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