Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design

Abstract

The International Campaign for Cures of Spinal Cord Injury Paralysis established a panel tasked with reviewing the methodology for clinical trials for spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the fourth of four papers. Here, we examine the phases of a clinical trial program, the elements, types, and protocols for valid clinical trial design. The most rigorous and valid SCI clinical trial would be a prospective double-blind randomized control trial utilizing appropriate placebo control subjects. However, in specific situations, it is recognized that other trial procedures may have to be considered. We review the strengths and limitations of the various types of clinical trials with specific reference to SCI. It is imperative that the design and conduct of SCI clinical trials should meet appropriate standards of scientific inquiry to insure that meaningful conclusions about efficacy and safety can be achieved and that the interests of trial subjects are protected. We propose these clinical trials guidelines for use by the SCI clinical research community.

Independent spinal cord atrophy measures correlate to motor and sensory deficits in individuals with spinal cord injury

“…1,2 More sensitive techniques could potentially have an important role for guiding and individualizing the rehabilitation and treatment of individuals with SCI. Diffusion tensor imaging and magnetization transfer have been suggested as MRI modalities for detection of lesions and evaluation of white matter integrity.…”

Diagnostic criteria of traumatic central cord syndrome. Part 2: A Questionnaire Survey among Spine Specialists

“…21 This finding is supported by a panel of SCI experts from the International Campaign for Cures of Spinal Cord Injury Paralysis, who published four reference works appraising methodological issues for the conduct of clinical trials in SCI. [22][23][24] Referring to higher spontaneous rates of overall sensory and motor recovery in TCCS, the expert panel considered TCCS patients 'not being the best subjects to be included with other types of traumatic SCI during a phase 1 or phase 2 trial, as they could increase the variability of the outcome data'. 24 To examine the hypothesis that TCCS patients truly have a higher rate of neurological recovery, the use of a clear diagnostic criterion may be of great benefit.…”

“…This may increase the risk of not detecting significant effects (type II error) in following comparative studies. 23 Hence, future clinical studies comparing the recovery of incomplete tetraplegic and TCCS patients should ideally be performed in large multicenter networks.…”

“…This led us to the development of the questions of this study. An interactive pilot questionnaire survey was created and a group of 22 participants of the 48th International Spinal Cord Society annual scientific meeting in Florence, [21][22][23][24] October 2009, were found to participate. Based On the answers, comments and suggestions of these 22 participants, a definitive online survey version was created using Quizmaker '09 (Articulate, New York, NY, USA).…”

Neurophysiological evaluation of segmental motor neuron function of the thoracic cord in chronic SCI

“…For this reason, the International Campaign for Cures of spinal cord injury Paralysis (ICCP) guidelines for clinical trials refer to patients with complete (American Spinal Injury Association (ASIA) Impairment Scale (AIS) A) lesions in the thoracic spinal cord as the preferred patient group for clinical trials. [2][3][4][5] Local adverse effects of a therapeutic strategy in these patients would be less likely to deteriorate function. On the other hand, the ICCP panel conclude that no widely accepted method for assessing local function of the thoracic spinal cord exists other than sensory evaluation according to the ASIA protocol.…”