Clinical trials in multiple sclerosis

Handbook of Clinical Neurology

Volumn 122, Issue , 2014, Pages 445-453

  Cutter, Gary ^a   Kappos, Ludwig ^b  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b UNIVERSITY HOSPITAL BASEL   (Switzerland)

Author keywords

Outcome measures; Phases of trials; Reliability; Trial Design; Trial principles; Validity

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; BAYES THEOREM; CLINICAL TRIAL (TOPIC); HUMAN; METHODOLOGY; MULTIPLE SCLEROSIS; OUTCOME ASSESSMENT; OUTCOME MEASURES; PHASES OF TRIALS; RELIABILITY; STUDY DESIGN; TRIAL PRINCIPLES; VALIDITY;

OUTCOME MEASURES; PHASES OF TRIALS; RELIABILITY; TRIAL DESIGN; TRIAL PRINCIPLES; VALIDITY;

BAYES THEOREM; BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; HUMANS; MULTIPLE SCLEROSIS; OUTCOME ASSESSMENT (HEALTH CARE); RESEARCH DESIGN;

EID: 84893488628     PISSN: 00729752     EISSN: None     Source Type: Book Series    
DOI: 10.1016/B978-0-444-52001-2.00019-4     Document Type: Chapter

References (9)

1. Aban I.B., Cutter G.R., Mavinga N. Inferences and power analysis concerning two negative binomial distributions with an application to MRI lesion counts data. Comput Stat Data Anal 2009, 53:820-833.
2. Mick R., Crowley J., Carroll R. Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint. Control Clin Trials 2000, 21:343-359.
3. Schneiderman M.A. Mouse to man: statistical problems in bringing a drug to clinical trial. Proceedings of the fifth Berkeley symposium on mathematical statistics and probability 1967, vol. IV:855-866. University of California Press, Berkeley (CA).
4. Schwid S., Cutter G. Futility studies: spending a little to save a lot. Neurology 2006, 66:626-627.
5. Sormani M.P., Rovaris M., Bagnato F., et al. Sample size estimations for MRI-monitored trials of MS comparing new vs standard treatments. Neurology 2001, 57:1883-1885.
6. Sormani M.P., Miller D.H., Comi G., et al. Clinical trials of multiple sclerosis monitored with enhanced MRI: new sample size calculations based on large data sets. J Neurol Neurosurg Psychiatry 2001, 70:494-499.
7. Suman V.J., Dueck A., Sargent D.J. Clinical trials of novel and targeted therapies: endpoints, trial design, and analysis. Cancer Invest 2008, 26:439-444.
8. The NINDS NET-PD Investigators A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease. Neurology 2006, 66:664-671.
9. Tilley B.C., Palesch Y.Y., Kieburtz K., et al. Optimizing the ongoing search for new treatments for Parkinson disease: using futility designs. Neurology 2006, 66:628-633.