Clinical Trials

❘❙❚■ Indexstratified randomization method, 300Consolidated Standards of Reporting Trials(CONSORT), 11cluster randomized trials, 148CONSORT see Consolidated Standardsof Reporting Trials (CONSORT)coordinating team, multicenter trials, 156–157correlation coefficient, definition, 454Corticosteroid Randomization After SignificantHead Injury (CRASH), 155costas endpoint measure, 44factorial design, 110multicenter trials, 162covariates, 287–294adjusted, 290–291analyses, 288unadjusted hazard ratios vs, 290advantages, 292example, 288–290see also primary biliary cirrhosis trialimbalance avoidance, 293limitations, 292linear regression model, 292logistic regression, 292methods, 291–292planning, 293rationale, 290–291stratified analysis, 292unadjusted analyses, 288adjusted vs, 290Cox regression model, 11, 292crossover clinical trials, 91–100between-subject comparisons, 95classification, 94–95complete, 94definition, 3, 92example, 92–93, 93, 93–94high-order, 95incomplete, 94interaction, 315limitations, 96–98parallel studies vs, 95–96parallel trials vs, 95, 96treatment-by-period, 315trial profile, 382, 382–383two-sequence, two-period design, 94, 94use of, 98within-subject comparisons, 95CURE (Clopidogrel in Unstable Anginato Prevent Recurrent Events), 40Ddataanalysis, 253–262meta-analysis, 443missing see missing datareview, subgroup analysis, 270types, 167–184definitions, 168–169dependent variables, 169examples, 169independent variables, 169survival data, 170data and safety monitoring board (DSMB), 10protocol development, 35Declaration of Helsinki, 24DerSimonian-Laird analysis, 447, 448determining diagnostic models, regressionanalysis, 283–284discussion section, 371reports, 367disease status, patient selection, 51–52dose-response curve, 3Do Tirofiban and ReoPro Give Similar EfficacyOutcomes Trial (TARGET), 116dot plots, 412–413, 414double-blind studies, 30, 78Eearly trial termination, 360–361effect modification, definition, 306effect sizes, reporting, 372eligibility criteria, 30–31patient selection, 50–51, 51endpoints, 37–46choice of, 39composite see composite endpointsdeath as, 39–40definition, 38, 454health-economic, 43–45advantages, 44limitations, 44–45primary, 38protocol development, 31secondary, 38surrogate, 42–43time to death, 39–40470