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Recognizing the huge advances in experimental treatments for spinal cord injury, four papers to be published online in the journal Spinal Cord address the need for a principled set of guidelines for clinical trials in patients with spinal damage.
Experimental interventions developed to improve functional outcomes after spinal cord injury (SCI) are expanding and several of these will undergo clinical trial programs in the near future. The International SCI Clinical Trials Guidelines Panel investigate four key areas and focus their initial recommendations on the design of clinical trials for experimental cell-based and pharmaceutical drug treatments for protection or repair of the injured spinal cord. They look at both acute and chronic stages of SCI. This focus is necessary because of the substantial risks and potential benefits of these types of treatments, and because some of these treatments have been offered without completing a clinical trial. The first paper describes the degree of spontaneous recovery that can occur after SCI. In addition, calculations have been made to estimate the number of subjects that would need to be recruited into a clinical trial to provide statistically significant results between an experimental treatment and control group. The second article examines clinical trial endpoints or outcome measures within three main classes: those that provide an anatomical or neurological assessment for the connectivity of the spinal cord, those that categorize a subject's functional ability to engage in activities of daily living, and those that measure an individual's quality of life. Next is a discussion of inclusion and exclusion criteria for the selection of clinical trial subjects, together with a review of confounding trial variables and ethical considerations for the conduct of trials. The final paper, in the linked series, reviews the phases of a clinical trial program, the elements, types and protocols for valid clinical trial design. This series of 4 articles contains a discussion and set of recommendations on the many factors that must be considered when designing clinical trials in SCI. - Spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials.
Abstract available online. - Clinical trial outcome measures.
Abstract available online. - Clinical trial inclusion/exclusion criteria and ethics.
Abstract available online. - Clinical trial design.
Abstract available online. Author contact details: John Steeves (University of British Columbia & Vancouver Coastal Health, Canada)
Email: steeves@icord.org Journal contact details: James Ashton (Assistant Editor, Nature Publishing Group)
E-mail: j.ashton@nature.com (C) Spinal Cord press release.
Message posted by: Trevor M. D'Souza
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