Clinical trials protocols for spinal cord injury
Performing successful clinical trials for spinal cord injury is challenging. Recognising that trials of treatments that were very promising was were about to begin, James Fawcett, John Steeves and Mark Tuszynski started an initiative on behalf of the ICCP, the international confederation of spinal injury associations, to develop recommendations for clinical trials methodology. Six papers have been published to date.
Steeves JD, Kramer JK, Fawcett JW, Cragg J, Lammertse DP, Blight AR, Marino RJ, Ditunno JF, Jr., Coleman WP, Geisler FH, Guest J, Jones L, Burns S, Schubert M, van Hedel HJ, Curt A (2011) Extent of spontaneous motor recovery after traumatic cervical sensorimotor complete spinal cord injury. Spinal Cord 49:257-265.
Zariffa J, Kramer JL, Fawcett JW, Lammertse DP, Blight AR, Guest J, Jones L, Burns S, Schubert M, Bolliger M, Curt A, Steeves JD (2011) Characterization of neurological recovery following traumatic sensorimotor complete thoracic spinal cord injury. Spinal Cord 49:463-471.
Fawcett,J.W., Curt,A., Steeves,J.D., Coleman,W.P., Tuszynski,M.H., Lammertse,D., Bartlett,P.F., Blight,A.R., Dietz,V., Ditunno,J., Dobkin,B.H., Havton,L.A., Ellaway,P.H., Fehlings,M.G., Privat,A., Grossman,R., Guest,J.D., Kleitman,N., Nakamura,M., Gaviria,M. & Short,D. (2007) 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. Spinal Cord., 45, 190-205.
Lammertse,D., Tuszynski,M.H., Steeves,J.D., Curt,A., Fawcett,J.W., Rask,C., Ditunno,J.F., Fehlings,M.G., Guest,J.D., Ellaway,P.H., Kleitman,N., Blight,A.R., Dobkin,B.H., Grossman,R., Katoh,H., Privat,A. & Kalichman,M. (2007) Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design. Spinal Cord., 45, 232-242.
Steeves,J.D., Lammertse,D., Curt,A., Fawcett,J.W., Tuszynski,M.H., Ditunno,J.F., Ellaway,P.H., Fehlings,M.G., Guest,J.D., Kleitman,N., Bartlett,P.F., Blight,A.R., Dietz,V., Dobkin,B.H., Grossman,R., Short,D., Nakamura,M., Coleman,W.P., Gaviria,M. & Privat,A. (2007) Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures. Spinal Cord., 45, 206-221.
Tuszynski,M.H., Steeves,J.D., Fawcett,J.W., Lammertse,D., Kalichman,M., Rask,C., Curt,A., Ditunno,J.F., Fehlings,M.G., Guest,J.D., Ellaway,P.H., Kleitman,N., Bartlett,P.F., Blight,A.R., Dietz,V., Dobkin,B.H., Grossman,R. & Privat,A. (2007) Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP Panel: clinical trial inclusion/exclusion criteria and ethics. Spinal Cord., 45, 222-231.