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1.

Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network.

Guest J, Harrop JS, Aarabi B, Grossman RG, Fawcett JW, Fehlings MG, Tator CH.

J Neurosurg Spine. 2012 Sep;17(1 Suppl):94-101. doi: 10.3171/2012.5.AOSPINE1289.

PMID:
22985376
2.

Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke.

Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B, Barr J, Dillon W, Warach S, Broderick J, Tilley B, Sacks D; Technology Assessment Committee of the American Society of Interventional and Therapeutic Neuroradiology; Technology Assessment Committee of the Society of Interventional Radiology.

Stroke. 2003 Aug;34(8):e109-37. Epub 2003 Jul 17. Erratum in: Stroke. 2003 Nov;34(11):2774.

3.

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials.

Fawcett JW, Curt A, Steeves JD, Coleman WP, Tuszynski MH, Lammertse D, Bartlett PF, Blight AR, Dietz V, Ditunno J, Dobkin BH, Havton LA, Ellaway PH, Fehlings MG, Privat A, Grossman R, Guest JD, Kleitman N, Nakamura M, Gaviria M, Short D.

Spinal Cord. 2007 Mar;45(3):190-205. Epub 2006 Dec 19. Review.

PMID:
17179973
4.

North American Clinical Trials Network for the Treatment of Spinal Cord Injury: goals and progress.

Grossman RG, Toups EG, Frankowski RF, Burau KD, Howley S.

J Neurosurg Spine. 2012 Sep;17(1 Suppl):6-10. doi: 10.3171/2012.4.AOSPINE1294.

PMID:
22985365
5.

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP Panel: clinical trial inclusion/exclusion criteria and ethics.

Tuszynski MH, Steeves JD, Fawcett JW, Lammertse D, Kalichman M, Rask C, Curt A, Ditunno JF, Fehlings MG, Guest JD, Ellaway PH, Kleitman N, Bartlett PF, Blight AR, Dietz V, Dobkin BH, Grossman R, Privat A; International Campaign for Cures of Spinal Cord Injury Paralysis.

Spinal Cord. 2007 Mar;45(3):222-31. Epub 2006 Dec 19. Review.

PMID:
17179971
6.

Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures.

Steeves JD, Lammertse D, Curt A, Fawcett JW, Tuszynski MH, Ditunno JF, Ellaway PH, Fehlings MG, Guest JD, Kleitman N, Bartlett PF, Blight AR, Dietz V, Dobkin BH, Grossman R, Short D, Nakamura M, Coleman WP, Gaviria M, Privat A; International Campaign for Cures of Spinal Cord Injury Paralysis.

Spinal Cord. 2007 Mar;45(3):206-21. Epub 2006 Dec 19. Review.

PMID:
17179972
7.

Spinal cord injury clinical trials translational process, review of past and proposed acute trials with reference to recommended trial guidelines.

Steeves J, Blight A.

Handb Clin Neurol. 2012;109:386-98. doi: 10.1016/B978-0-444-52137-8.00024-3.

PMID:
23098726
8.

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

Lammertse D, Tuszynski MH, Steeves JD, Curt A, Fawcett JW, Rask C, Ditunno JF, Fehlings MG, Guest JD, Ellaway PH, Kleitman N, Blight AR, Dobkin BH, Grossman R, Katoh H, Privat A, Kalichman M; International Campaign for Cures of Spinal Cord Injury Paralysis.

Spinal Cord. 2007 Mar;45(3):232-42. Epub 2006 Dec 19. Review.

9.

Issues in data monitoring and interim analysis of trials.

Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MK, Pocock SJ, Spiegelhalter DJ, Sydes MR, Walker AE, Wallace SA; DAMOCLES study group.

Health Technol Assess. 2005 Mar;9(7):1-238, iii-iv. Review.

10.

The NCI All Ireland Cancer Conference.

Johnston PG, Daly PA, Liu E.

Oncologist. 1999;4(4):275-277.

11.

Procedures and methods of benefit assessments for medicines in Germany.

Bekkering GE, Kleijnen J.

Eur J Health Econ. 2008 Nov;9 Suppl 1:5-29. doi: 10.1007/s10198-008-0122-5.

PMID:
18987905
12.

Risk management frameworks for human health and environmental risks.

Jardine C, Hrudey S, Shortreed J, Craig L, Krewski D, Furgal C, McColl S.

J Toxicol Environ Health B Crit Rev. 2003 Nov-Dec;6(6):569-720. Review.

PMID:
14698953
13.

Riluzole for the treatment of acute traumatic spinal cord injury: rationale for and design of the NACTN Phase I clinical trial.

Fehlings MG, Wilson JR, Frankowski RF, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Harkema SJ, Guest JD, Tator CH, Burau KD, Johnson MW, Grossman RG.

J Neurosurg Spine. 2012 Sep;17(1 Suppl):151-6. doi: 10.3171/2012.4.AOSPINE1259.

PMID:
22985381
14.

Translational potential of preclinical trials of neuroprotection through pharmacotherapy for spinal cord injury.

Tator CH, Hashimoto R, Raich A, Norvell D, Fehlings MG, Harrop JS, Guest J, Aarabi B, Grossman RG.

J Neurosurg Spine. 2012 Sep;17(1 Suppl):157-229. doi: 10.3171/2012.5.AOSPINE12116. Review.

PMID:
22985382
16.

Clinical trials in spinal cord injury.

Blight AR, Tuszynski MH.

J Neurotrauma. 2006 Mar-Apr;23(3-4):586-93. Review.

PMID:
16629639
17.

Recommendations for translation and reliability testing of International Spinal Cord Injury Data Sets.

Biering-Sørensen F, Alexander MS, Burns S, Charlifue S, DeVivo M, Dietz V, Krassioukov A, Marino R, Noonan V, Post MW, Stripling T, Vogel L, Wing P; Executive Committee for the International SCI Standards and Data Sets.

Spinal Cord. 2011 Mar;49(3):357-60. doi: 10.1038/sc.2010.153. Epub 2010 Nov 9.

PMID:
21060313
18.

Predictors of pulmonary complications in blunt traumatic spinal cord injury.

Aarabi B, Harrop JS, Tator CH, Alexander M, Dettori JR, Grossman RG, Fehlings MG, Mirvis SE, Shanmuganathan K, Zacherl KM, Burau KD, Frankowski RF, Toups E, Shaffrey CI, Guest JD, Harkema SJ, Habashi NM, Andrews P, Johnson MM, Rosner MK.

J Neurosurg Spine. 2012 Sep;17(1 Suppl):38-45. doi: 10.3171/2012.4.AOSPINE1295.

PMID:
22985369
19.

Alternative strategies in drug development: clinical pharmacological aspects.

Kuhlmann J.

Int J Clin Pharmacol Ther. 1999 Dec;37(12):575-83. Review.

PMID:
10599949
20.

American Society of Clinical Oncology Statement on minimum standards and exemplary attributes of clinical trial sites.

Zon R, Meropol NJ, Catalano RB, Schilsky RL.

J Clin Oncol. 2008 May 20;26(15):2562-7. doi: 10.1200/JCO.2007.15.6398. Epub 2008 Apr 7.

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