Fundamentals of Clinical TrialsSpringer Science & Business Media, 1998 - 361 pages Intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol, it is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The text uses numerous examples of published clinical trials from a variety of medical disciplines to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered, but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity. |
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Contents
Introduction to Clinical Trials | 1 |
What Is the Question? | 16 |
Basic Study Design | 41 |
41 | 58 |
Blocked Randomization | 64 |
Study Population | 73 |
Mechanics of Randomization | 74 |
Blindness | 82 |
Data Collection and Quality Control | 156 |
Assessing and Reporting Adverse Effects | 170 |
Assessment of HealthRelated Quality of Life | 185 |
Participant Adherence | 204 |
17 | 220 |
Survival Analysis | 223 |
Monitoring Response Variables | 246 |
122 | 280 |
Sample Size | 94 |
Dichotomous Response Variables | 100 |
Sample Size Calculations for Continuous Response Variables | 109 |
Sample Size for Testing Equivalency of Interventions | 118 |
References | 125 |
Baseline Assessment | 130 |
Recruitment of Study Participants | 140 |
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Common terms and phrases
adherence adverse effects allocation analysis approach aspirin Aspirin Myocardial Infarction assessment assigned baseline Beta-Blocker Beta-Blocker Heart Attack bias Biometrics Biometrika blood pressure cancer Cardiac Arrhythmia censored Chapter cholesterol chronic compared comparison confidence interval control group Controlled Clin Trials Coronary Drug Project coronary heart disease covariates data monitoring committee DeMets detect difference discussed double-blind electrocardiograms Engl enrollment estimate evaluation event rates example follow-up function group sequential Heart Attack Trial HRQL HRQL measures hypertension important intervention group investigator JAMA long-term methods mortality multicenter trial Myocardial Infarction Study nonadherence null hypothesis number of participants observed outcome pants patients placebo population primary response variable problems procedures prognostic factors propranolol protocol randomized clinical trials randomized trial recruitment reduced reported require Research Group sample sample size significance level specific Stat statistic stratified study groups subgroup surgery survival analysis survival curve symptoms therapy tion treatment unblinded visits