Placebo cohorts in phase-3 MS treatment trials - predictors for on-trial disease activity 1990-2010 based on a meta-analysis and individual case data.
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Placebo cohorts in phase-3 MS treatment trials - predictors for on-trial disease activity 1990-2010 based on a meta-analysis and individual case data. / Stellmann, Jan-Patrick; Neuhaus, Anneke; Herich, Lena; Schippling, Sven; Roeckel, Matthias; Daumer, Martin; Martin, Roland; Heesen, Christoph.
in: PLOS ONE, Jahrgang 7, Nr. 11, 11, 2012, S. 50347.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Placebo cohorts in phase-3 MS treatment trials - predictors for on-trial disease activity 1990-2010 based on a meta-analysis and individual case data.
AU - Stellmann, Jan-Patrick
AU - Neuhaus, Anneke
AU - Herich, Lena
AU - Schippling, Sven
AU - Roeckel, Matthias
AU - Daumer, Martin
AU - Martin, Roland
AU - Heesen, Christoph
PY - 2012
Y1 - 2012
N2 - Annualized relapse rates (ARR) in the placebo cohorts of phase-3 randomized controlled trials (RCT) of new treatments for relapsing remitting multiple sclerosis (RRMS) have decreased substantially during the last two decades. The causes of these changes are not clear. We consider a better understanding of this phenomenon essential for valuing the effects of new drugs and by designing new trials.
AB - Annualized relapse rates (ARR) in the placebo cohorts of phase-3 randomized controlled trials (RCT) of new treatments for relapsing remitting multiple sclerosis (RRMS) have decreased substantially during the last two decades. The causes of these changes are not clear. We consider a better understanding of this phenomenon essential for valuing the effects of new drugs and by designing new trials.
KW - Humans
KW - Male
KW - Female
KW - Randomized Controlled Trials as Topic
KW - Cohort Studies
KW - Regression Analysis
KW - Time Factors
KW - Research Design
KW - Recurrence
KW - Outcome Assessment (Health Care)
KW - Poisson Distribution
KW - Models, Statistical
KW - Clinical Trials, Phase III as Topic
KW - Multiple Sclerosis, Relapsing-Remitting/therapy
KW - Placebos
KW - Humans
KW - Male
KW - Female
KW - Randomized Controlled Trials as Topic
KW - Cohort Studies
KW - Regression Analysis
KW - Time Factors
KW - Research Design
KW - Recurrence
KW - Outcome Assessment (Health Care)
KW - Poisson Distribution
KW - Models, Statistical
KW - Clinical Trials, Phase III as Topic
KW - Multiple Sclerosis, Relapsing-Remitting/therapy
KW - Placebos
U2 - 10.1371/journal.pone.0050347
DO - 10.1371/journal.pone.0050347
M3 - SCORING: Journal article
VL - 7
SP - 50347
JO - PLOS ONE
JF - PLOS ONE
SN - 1932-6203
IS - 11
M1 - 11
ER -