@article{61bcd71e9cce41fabef4ba97fc64922a,
title = "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.",
keywords = "ASIA, Clinical trial, Clinical trial design, Clinical trial protocols, Motor system, Sensory system, Spinal cord injury, Trial assessment, Trial oversight",
author = "D. Lammertse and Tuszynski, {M. H.} and Steeves, {J. D.} and A. Curt and Fawcett, {J. W.} and C. Rask and Ditunno, {J. F.} and Fehlings, {M. G.} and Guest, {J. D.} and Ellaway, {P. H.} and N. Kleitman and Blight, {A. R.} and Dobkin, {B. H.} and R. Grossman and H. Katoh and A. Privat and M. Kalichman",
note = "Funding Information: We are grateful for the support of The International Campaign for Cures of spinal cord injury Paralysis (ICCP), which provided the funding for the authors{\textquoteright} travel and accommodation expenses. The ICCP represents the following member organizations: Christopher Reeve Foundation (USA), Institut pour la Recherche sur la Mo{\"e}lle Epini{\`e}re (FRA), International Spinal Research Trust (UK), Japan Spinal Cord Foundation, Miami Project to Cure Paralysis (USA), Paralyzed Veterans of America (USA), Rick Hansen Man In Motion Foundation (CAN), SpinalCure Australia, and Spinal Research Fund of Australia. We thank the European Multicenter study in SCI (EM-SCI) for sharing their data on spontaneous recovery after SCI. ICORD (International Collaboration On Repair Discoveries) in Vancouver provided all logistical coordination and support. All panel members (authors) volunteered their time and effort. This article was co-authored by N. Kleitman in her private capacity. No official support or endorsement by the National Institutes of Health is intended or should be inferred.",
year = "2007",
month = mar,
day = "30",
doi = "10.1038/sj.sc.3102010",
language = "English (US)",
volume = "45",
pages = "232--242",
journal = "Spinal Cord",
issn = "1362-4393",
publisher = "Nature Publishing Group",
number = "3",
}