- Section 1 The development of the discipline of public health
- Section 2 Determinants of health and disease
- Section 3 Public health policies, law, and ethics
- Section 4 Information systems and sources of intelligence
- Section 5 Epidemiological and biostatistical approaches
- 5.1 Epidemiology: the foundation of public health
- 5.2 Ecological variables, ecological studies, and multilevel studies in public health research
- 5.3 Cross-sectional studies
- 5.4 Principles of outbreak investigation
- 5.5 Case–control studies
- 5.6 Cohort studies
- 5.7 Methodology of intervention trials in individuals
- 5.8 Methodological issues in the design and analysis of community intervention trials
- 5.9 Community intervention trials in high-income countries
- 5.10 Community-based intervention trials in low- and middle-income countries
- 5.11 Clinical epidemiology
- 5.12 Genetic epidemiology
- 5.13 Validity and bias in epidemiological research
- 5.14 Causation and causal inference
- 5.15 Systematic reviews and meta-analysis
- 5.16 Statistical methods
- 5.17 Measuring the health of populations: the Global Burden of Disease study methods
- 5.18 Mathematical models of transmission and control of infectious agents
- 5.19 Public health surveillance
- 5.20 Life course epidemiology and analysis
- Section 6 Social science techniques
- Section 7 Environmental and occupational health sciences
- Section 8 Major health problems
- Section 9 Prevention and control of public health hazards
- Section 10 Public health needs of population groups
- Section 11 Public health functions
(p. 484) Methodology of intervention trials in individuals
- Chapter:
- (p. 484) Methodology of intervention trials in individuals
- Author(s):
Lawrence M. Friedman
and Eleanor B. Schron
- DOI:
- 10.1093/med/9780199661756.003.0109
The chapter on methodology of intervention trials in individuals presents key issues in the design, conduct, monitoring, analysis, and reporting of clinical trials. The chapter emphasizes the conduct of late phase trials, those performed in order to assess whether a new intervention is better than a control. Different sorts of trial design, including the special considerations of non-inferiority versus superiority trials are reviewed. The advantages and limitations of surrogate outcomes are covered, as is the use of quality of life as an outcome measure. The chapter discusses ethical issues, such as appropriateness of randomization, selection of the comparison group, clinical trials in emergency settings, and trials in developing countries. Approaches to data and safety monitoring are discussed, as are analysis issues such as intention-to-treat.
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- Section 1 The development of the discipline of public health
- Section 2 Determinants of health and disease
- Section 3 Public health policies, law, and ethics
- Section 4 Information systems and sources of intelligence
- Section 5 Epidemiological and biostatistical approaches
- 5.1 Epidemiology: the foundation of public health
- 5.2 Ecological variables, ecological studies, and multilevel studies in public health research
- 5.3 Cross-sectional studies
- 5.4 Principles of outbreak investigation
- 5.5 Case–control studies
- 5.6 Cohort studies
- 5.7 Methodology of intervention trials in individuals
- 5.8 Methodological issues in the design and analysis of community intervention trials
- 5.9 Community intervention trials in high-income countries
- 5.10 Community-based intervention trials in low- and middle-income countries
- 5.11 Clinical epidemiology
- 5.12 Genetic epidemiology
- 5.13 Validity and bias in epidemiological research
- 5.14 Causation and causal inference
- 5.15 Systematic reviews and meta-analysis
- 5.16 Statistical methods
- 5.17 Measuring the health of populations: the Global Burden of Disease study methods
- 5.18 Mathematical models of transmission and control of infectious agents
- 5.19 Public health surveillance
- 5.20 Life course epidemiology and analysis
- Section 6 Social science techniques
- Section 7 Environmental and occupational health sciences
- Section 8 Major health problems
- Section 9 Prevention and control of public health hazards
- Section 10 Public health needs of population groups
- Section 11 Public health functions