What you should know if you are considering participation in a clinical trial.

Deciding to participate in a research study takes careful consideration. There is the commitment and the practical issues such as transportation to factor in. However, many people who take part in SCI research report a sense of accomplishment that comes from knowing they have personally contributed to a body of knowledge that promises to result in improved quality of life for all people with SCI, and ultimately, a cure.

We would like to stress the importance of doing your due diligence prior to participating in any research study, particularly clinical trials dealing with new, untested experimental therapies. A number of experimental therapies, such as cellular transplants, are being introduced into clinical practice without a valid clinical trial program being completed, leaving their safety and efficacy untested. This is a great concern to researchers, clinicians and, most importantly, people with SCI.

In order to establish a set of guidelines for the design and conduct of valid clinical trials for SCI, an expert panel of researchers and doctors with extensive scientific and clinical experience in SCI was formed in 2004. The panel, supported through the ICCP (International Campaign for Cures for spinal cord injury Paralysis), developed a set of four papers outlining the guidelines for the conduct of SCI clinical trials, which were published in the journal Spinal Cord (see below). In addition to these peer-reviewed publications, the panel summarized these guidelines in an easy-to-read booklet.

The following documents are now available for free download at the ICORD (International Collaboration On Repair Discoveries) website:

Experimental Treatments for Spinal Cord Injuries: What you should know if you are considering participation in a clinical trial. This easy-to-read booklet, produced by the ICCP, provides you first with an overview of the ASIA scale and spontaneous recovery, and then looks at the risks of unapproved treatments. You will discover how clinical trials work, from Phase 1 to Phase 4, as well as the basics of trial design and pre-clinical studies. You will read about the ethics of clinical trials, bias, controls, and the importance of informed consent are then discussed, followed by a review of some scales that are used to measure functional benefits. You will learn about some concerns that might arise regarding the possibility of taking part in a future trial after already participating in a trial. You will then be introduced to some experimental approaches to SCI currently being studied. Finally, the document provides you with a list of questions that you can pose to a researcher inviting you to participate in a human study. This checklist might assist you in your decision whether or not to participate in the trial.

• Click here to download this 40-page guide for people with spinal cord injury, their families, friends and caregivers. (2.4MB)
• Click here to download the summary version. (1.1MB)

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel and published in the journal, Spinal Cord. Click here to visit the Spinal Cord website, where the following 4 documents can be downloaded for free from the journal's home page: 1. Spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials; 2. Clinical trial outcome measures; 3. Clinical trial inclusion/exclusion criteria and ethics; and 4. Clinical trial design.

Please note: To view the documents, you will require an application capable of reading PDF (portable document format) files, such as the free Adobe Acrobat Reader or Apple's Preview.