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

Increasingly, advances in spinal cord injury (SCI) research are finding their way into clinical practice. Many of these experimental therapies are currently undergoing clinical trials or are preparing to enter the clinical trial phase of their development. However, 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.

For people with SCI, their families, friends and caregivers, the decision to receive an experimental treatment or enter a clinical trial is a challenging one. 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 4 papers outlining the guidelines for the conduct of SCI clinical trials, which were published in the Nature journal, Spinal Cord (see below). In addition to these peer-reviewed publications, the panel summarized these guidelines in an easy-to-read booklet.

Documents now available for download:

• These resources are an important sources of information and have been made available for free download for everyone interested.
• Click on the images or links below to download your copy of the documents.*

	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)
	International Translations of the Experimental Treatments for Spinal Cord Injuries: What you should know if you are considering participation in a clinical trial. The Spanish and German translations are now available. Other translations currently being completed include: French, Chineses, Italian and Swedish. Tratamientos experimentales para lesiones en la médula espinal: lo que debe saber si está pensando en la posibilidad de participar en un estudio clínico. Guía para personas con lesiones en la médula espinal y sus familiares, amigos y cuidadores. Translation services for the Spanish version of this document were generously provided by the Christopher and Dana Reeve Foundation. Experimentelle Therapien für Rückenmarksverletzungen: Was Sie wissen sollten wenn Sie an einer klinischen Studie teilnehmen môchten. Ein Leitfaden für Menschen mit einer Rückenmarksverletzung, ihre Familien, Freunde und Betreuer. Ein Zusammenfassung für Menschen mit einer Rückenmarksverletzung, ihre Familien, Freunde und Betreuer. Support for the German translation was provided by Wings for Life. Japanese translation of Experimental Treatments for Spinal Cord Injuries: What you should know if you are considering participation in a clinical trial. Support for the Japanese translation was provided by the Japan Spinal Cord Foundation. Chinese translation of Experimental Treatments for Spinal Cord Injuries: What you should know if you are considering participation in a clinical trial. The Chinese translation is presented courtesy of Dr. Dajue Wang and Dr. Jie Liu.
	Summary Document for the Experimental Treatments for Spinal Cord Injuries: What you should know if you are considering participation in a clinical trial. Click here to download the 10-page summary and overview of the full guide for people considering participation in a spinal cord injury-related clinical trial. (1.1MB) Please note, an alternate version of the summary is available. Click here to download a version of the summary in which the "Participation Checklist" is omitted (the rest of the content is the same as the summary document above). (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 4. Clinical trial design

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