Clinical Trials

❘❙❚■ IndexNote: Page numbers in italics refer to tables or boxed material. Page numbersin bold refer to figures. vs indicates a comparison.Aabbreviations, protocol development, 26abstract, reports, 367–368adaptive randomization procedure(minimization), 72–73administrative considerations,protocol development, 32allocated treatment, CONSORT statement, 371allocation concealment, 9analysis of covariance (ANCOVA), 291analysis of variance (ANOVA), 213area under the curvecalculation, bioequivalence trials, 122, 122, 124normal distribution see normal distributionrepeated measurements, 322, 324–325ascertainment (observer) bias, 60–61asterisks, tables, 404AUC 0–t, bioequivalence trials, 122, 122Bbar charts, 171, 410–411, 411, 423baseline data presentation see reports/reportingbaseline variables adjustment, regressionanalysis, 282Beta-blocker Heart Attack Trial (BHAT),early trial termination, 360–361Beta-Carotene and Retinol Efficacy Trial,early trial termination, 361between-subject comparisons, crossoverclinical trials, 95between-subject variability, equivalencetrials, 115–116bias, 55–64cluster randomized trials, 147, 147–148definition, 5, 56minimization, 66see also randomizationobserver (ascertainment) bias, 61–62post randomization exclusions, 62publication see publication biasselection bias see selection biasstudy management bias see studymanagement biastypes, 57biocreep, 135bioequivalence trials, 115, 119–130basic designs, 126–127, 127definition, 114, 120evaluation, 127–129confidence interval calculation,127–129, 128, 128Latin square design, 126–127, 127pharmacokinetics, 120–121, 121AUC 0–∞, 124AUC 0–t, 122, 122calculation, 122–126C max, 122λ, 123–124, 124sampling period, 125–126, 126sampling times, 125T 1/2, 123–124, 124T max, 122blank cells, tables, 404blinding, 9, 60–61, 75–80achieving of, 61assessment, 80coding of drugs, 79definition, 76necessity of, 76types, 77–79double-blinded studies, 60, 78open (unblinded) studies, 77single-blinded studies, 60, 77–78triple-blinded studies, 60–61, 78–79unblinding studies, 79block randomization, 68–70, 69Bonferroni correction, 333–334box plots, 174, 174, 414–416, 416, 423CCandesartan in Heart failure – Assessmentof Reduction in Mortality and morbidity(CHARM), 7–13allocation concealment, 9‘blinding,’ 9conduct of, 9design, 8endpoints, 7–8final data analysis, 10–11interim monitoring, 10468