Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: An efficient, dose-adaptive, seamless phase II/III design
ACUTE DISEASE;
CLINICAL TRIALS, PHASE II AS TOPIC;
CLINICAL TRIALS, PHASE III AS TOPIC;
COMPUTER SIMULATION;
DOSE-RESPONSE RELATIONSHIP, DRUG;
DOUBLE-BLIND METHOD;
DRUG APPROVAL;
EARLY TERMINATION OF CLINICAL TRIALS;
FIBRINOLYTIC AGENTS;
HUMANS;
MULTICENTER STUDIES AS TOPIC;
PATIENT SELECTION;
RANDOMIZED CONTROLLED TRIALS AS TOPIC;
RESEARCH DESIGN;
SELECTION BIAS;
STROKE;
TISSUE PLASMINOGEN ACTIVATOR;
U.S. Department of Health and Human Services Food and Drug Administration, CDER/CBER, February, 2010 Available at accessed 15 September 2010
U.S. Department of Health and Human Services Food and Drug Administration, CDER/CBER, February, 2010. Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM201790.pdf (accessed 15 September 2010).
NIHSS training and certification using a new digital video disk is reliable
DOI 10.1161/01.STR.0000185725.42768.92
Lyden P, Raman R, Liu L, et al. NIHSS training and certification using a new digital video disk is reliable. Stroke. 2005 ; 36: 2446-49 (Pubitemid 41566975)
A pilot dose-escalation safety study of tenecteplase in acute ischemic stroke
DOI 10.1161/01.STR.0000154872.73240.e9
Haley EC, Lyden PD, Johnston KC, Hemmen TM. The TNK in Stroke Investigators. A pilot dose-escalation safety study of tenecteplase in acute ischemic stroke. Stroke. 2005 ; 36: 607-12 (Pubitemid 40344164)
Tissue Plasminogen Activator for Acute Ischemic Stroke in Clinical Practice: A Meta-Analysis of Safety Data
DOI 10.1161/01.STR.0000101752.23813.C3
Graham G. Tissue plasminogen activator for acute ischemic stroke in clinical practice: a meta-analysis of safety data. Stroke. 2003 ; 34: 2847-50 (Pubitemid 37517754)