- Foreword
- Preface
- Acknowledgements
- Contributors
- Symbols and abbreviations
- Chapter 1 Research: why and how?
- Chapter 2 Navigating research methods: basic concepts in biostatistics and epidemiology
- Chapter 3 Navigating research methods: quantitative and clinical/epidemiological methods
- Chapter 4 Navigating research methods: qualitative methods
- Chapter 5 Navigating research methods: evidence-based medicine (EBM)
- Chapter 6 Navigating research methods: critical appraisal
- Chapter 7 Navigating research methods: clinical audit
- Chapter 8 Setting the scene and ICH GCP in clinical and healthcare research
- Chapter 9 Informed consent in a research setting
- Chapter 10 Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act
- Chapter 11 Role and responsibilities: investigator and research team
- Chapter 12 Role and responsibilities of the sponsor
- Chapter 13 Monitoring
- Chapter 14 Clinical trial design
- Chapter 15 Clinical trial protocols: study protocol
- Chapter 16 Data capture tools: case report form (CRF)
- Chapter 17 Clinical trial supplies: investigational medicinal products (IMPs)
- Chapter 18 IMP accountability
- Chapter 19 Safety reporting
- Chapter 20 Data management
- Chapter 21 Research project management
- Chapter 22 Essential documents
- Chapter 23 Archiving
- Chapter 24 Audits and inspections
- Chapter 25 Fraud and misconduct
- Chapter 26 Authorship
- Chapter 27 Publication process
- Chapter 28 Start-up toolkit: from funding an idea, through implementation, to achieving an impact
- Index
(p. 265) Clinical trial design
- Chapter:
- (p. 265) Clinical trial design
- DOI:
- 10.1093/med/9780199608478.003.0014
This chapter outlines the various study designs and their uses. The phases of drug development are described and the appropriate study design employed at each phase of development is identified Elimination of bias is critical to the study design and methods of eliminating bias are discussed, defining the population, randomisation and blinding. A summary of the elements to be considered when designing a study are presented including the types of control, placebo or active, and their uses, Non comparative and comparative designs are presented. In the comparative design both within and between patient designs are discussed including crossover, parallel, sequential, factorial and left right comparisons. Patient outcomes measures as well as efficacy measurement are required for new treatments. There is a brief review of pharmaeconomic study designs. Other types of study design, dose escalation and dose response studies are also discussed. As well as reducing bias in studies another critical element is the recording of the primary assessment methods. The choice of methods will affect other aspects of the study such as the statistical considerations. The methodology must be standardised and validated.
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- Foreword
- Preface
- Acknowledgements
- Contributors
- Symbols and abbreviations
- Chapter 1 Research: why and how?
- Chapter 2 Navigating research methods: basic concepts in biostatistics and epidemiology
- Chapter 3 Navigating research methods: quantitative and clinical/epidemiological methods
- Chapter 4 Navigating research methods: qualitative methods
- Chapter 5 Navigating research methods: evidence-based medicine (EBM)
- Chapter 6 Navigating research methods: critical appraisal
- Chapter 7 Navigating research methods: clinical audit
- Chapter 8 Setting the scene and ICH GCP in clinical and healthcare research
- Chapter 9 Informed consent in a research setting
- Chapter 10 Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act
- Chapter 11 Role and responsibilities: investigator and research team
- Chapter 12 Role and responsibilities of the sponsor
- Chapter 13 Monitoring
- Chapter 14 Clinical trial design
- Chapter 15 Clinical trial protocols: study protocol
- Chapter 16 Data capture tools: case report form (CRF)
- Chapter 17 Clinical trial supplies: investigational medicinal products (IMPs)
- Chapter 18 IMP accountability
- Chapter 19 Safety reporting
- Chapter 20 Data management
- Chapter 21 Research project management
- Chapter 22 Essential documents
- Chapter 23 Archiving
- Chapter 24 Audits and inspections
- Chapter 25 Fraud and misconduct
- Chapter 26 Authorship
- Chapter 27 Publication process
- Chapter 28 Start-up toolkit: from funding an idea, through implementation, to achieving an impact
- Index