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David Machin
Randomised Clinical Trials
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Вернуться на страницу книги Randomised Clinical Trials
Оглавление
Страница 1
Table of Contents
List of Tables
List of Illustrations
Guide
Pages
Randomised Clinical Trials Design, Practice and Reporting
Страница 8
Страница 9
Preface
Страница 11
CHAPTER 1 Introduction
1.1 Introduction
1.2 Some completed trials
Example 1.1 Small parallel two‐group design – gastrointestinal function
Example 1.2 Parallel two‐group design – hepatitis B
Example 1.3 Unstructured three‐group design – newly diagnosed type 2 diabetes
Example 1.4 Small dose–response design – pain prevention following hand surgery
Example 1.5 Large dose–response design – HER2‐positive breast cancer
Example 1.6 Non‐inferiority trial – uncomplicated falciparum malaria
Example 1.7
Repeated measures – atopic eczema
Example 1.8 Cross‐over trial – known or suspected hypertension
Example 1.9 Paired design – glaucoma
Example 1.10 Split‐mouth design – implants for edentulous sites
Example 1.11 Cluster trial – hip protectors for the elderly
Example 1.12
Single arm – discrete de novo lesions in a coronary artery
1.3 Choice of design 1.3.1 Biological variability
Example 1.13 Patient‐to‐patient variability – atopic eczema
1.3.2 Randomisation
1.3.3 Design hierarchy
1.3.3.1 Randomisation
1.3.3.2 Blinding or masking
1.3.3.3 Non‐randomised designs
Example 1.14 Glioblastoma in the elderly – non‐randomised design
1.3.3.4 Case series
1.4 Practical constraints
1.5 Influencing clinical practice
1.6 History
1.7 How do trials arise?
1.8 Ethical considerations
1.9 Regulatory requirements
1.10 Focus
1.11 Further reading
CHAPTER 2 Design Features
2.1 Introduction
Example 2.1 Two‐group parallel design – symptomatic oral lichen planus
2.2 The research question
2.3 Patient selection
Example 2.2 Trial eligibility – partial thickness burns
2.4 The consent process
2.5 Choice of interventions
2.5.1 Standard or control treatment
Example 2.3 Placebo controlled trial – advanced hepatocellular carcinoma
Example 2.4 Schizophrenia and schizophreniform disorder
2.5.2 Test treatment
2.6 Choice of design
2.7 Assigning the interventions
Example 2.5 Delay to start of treatment – inoperable non‐small‐cell lung cancer
2.8 Making the assessments
2.9 Analysis and reporting
2.9.1 Which patients to analyse
Example 2.6 Immediate start of treatment– children with fever
2.9.1.1 Intention‐to‐treat (ITT)
2.9.1.2 Per‐protocol
2.9.2 Trial publication
2.10 Technical details 2.10.1 Statistical models
2.10.2 Fitting the model
2.10.3 Choice of design
2.10.4 Randomisation
2.11 Guidelines
2.12 Further reading
CHAPTER 3 The Trial Protocol
3.1 Introduction
3.2 Abstract
Example 3.1 Protocol SQGL02 (1999): Brimonidine as a neuroprotective agent in acute angle‐closure glaucoma (AACG)
Example 3.2
Protocol SQCP01 (2006): Comparing speech and growth outcomes between two different techniques and two different timings of surgery in the management of clefts of the secondary palate
3.3 Background
3.4 Research objectives
3.4.1 Objectives
Example 3.3 Protocol SQNP01 (1997): Standard radiotherapy versus concurrent chemo‐radiotherapy followed by adjuvant chemotherapy for locally advanced (non‐metastatic) nasopharyngeal cancer
Example 3.4 Protocol PRESSURE (2000) Part Section 2: Pressure‐relieving support surfaces: a randomised evaluation 2. RESEARCH OBJECTIVES 2.1 Primary objective
2.2 Secondary objective
3.4.2 Outcome measures
Example 3.5
Protocol PRESSURE (2000) Part Section 9.1: Pressure‐relieving support surfaces: a randomised evaluation 9.1 Primary endpoint
9.1.1 Development of new pressure sores
9.2 Secondary endpoints
9.2.1 Healing of existing pressure sores
9.2.2 Patient acceptability
Example 3.6 Protocol AHCC01 (1997): Randomised trial of tamoxifen versus placebo for the treatment of inoperable hepatocellular carcinoma
3.5 Design
Example 3.7 Protocol PRESSURE (2000): Pressure‐relieving support surfaces: a randomised evaluation 3. DESIGN
3.6 Intervention details
Example 3.8 Protocol PRESSURE (2000): Pressure‐relieving support surfaces: a randomised evaluation
Example 3.9 Protocol SQNP01 (1997): Standard radiotherapy versus concurrent chemo‐radiotherapy followed by adjuvant chemotherapy for locally advanced (non‐metastatic) nasopharyngeal cancer
Example 3.10 Protocol SQOLP01 (1999): Comparison of steroid with cyclosporine for the topical treatment of oral lichen planus
Dose and duration
Steroid (S) –
Triamcinolone acetonide 0.1% in oral base (Kenalog)
Cyclosporine (C) –
Sandimmun Neoral solution 100 mg cyclosporine/ml
Application of topical medication
Dose modification
Example 3.11 Protocol ENSG5 (1990): Comparison of high dose rapid schedule with conventional schedule chemotherapy for stage 4 neuroblastoma over the age of 1 year 12. MODIFICATION OF THERAPY DUE TO TOXICITY
3.7 Eligibility
Example 3.12 Protocol UKW3 (1992): Preoperative chemotherapy in Wilms’ tumour 4. ELIGIBILITY
Example 3.13 Protocol PRESSURE (2000) Section 6.2: Pressure‐relieving support surfaces: a randomised evaluation 6.2 Exclusion criteria
3.8 Randomisation
3.8.1 Design
Example 3.14 Protocol PRESSURE (2000) Section 7.2: Pressure‐relieving support surfaces: a randomised evaluation 7.2 Mattress Allocation Method
3.8.2 Implementation
Example 3.15 Protocol SQOLP01 (1999, Section 7): Comparison of steroid with cyclosporine for the topical treatment of oral lichen planus 7. Randomisation
Example 3.16 Protocol EXPEL (2016): Peritoneal lavage after curative gastrectomy Enrolment and randomisation
Example 3.17 Protocol SQGL02 (1999): Brimonidine as a neuroprotective agent in acute angle‐closure glaucoma (AACG)
Procedure for randomisation
3.9 Assessment and data collection 3.9.1 Assessments
Example 3.18 Protocol SQCP01 (2006): Comparing speech and growth outcomes between two different techniques and two different timings of surgery in the management of clefts of the secondary palate Method
Example 3.19
Protocol PRESSURE (2000): Pressure‐relieving support surfaces: a randomised evaluation
3.9.2 Data collection
3.10 Statistical considerations
3.10.1 Number of subjects
Example 3.20 Protocol SQGL02: Brimonidine as a neuroprotective agent in acute angle‐closure glaucoma (AACG) 9. STATISTICAL CONSIDERATIONS
Trial size
3.10.2 Analysis
Example 3.21 Protocol SQOLP01 (1999): Comparison of steroid with cyclosporine for the topical treatment of oral lichen planus
Analysis plan
Primary endpoints
Clinical response at 4 weeks
Pain score 4 weeks
Secondary analyses
Adverse events
Additional analysis
3.10.3 Interim analysis
Example 3.22
Protocol EXPEL (2016): Peritoneal lavage after curative gastrectomy
3.11 Ethical issues
3.11.1 General
Example 3.23 Protocol PRESSURE (2000): Pressure‐relieving support surfaces: a randomised evaluation
Example 3.24 Protocol SQGL02 (1999): Brimonidine as a neuroprotective agent in acute angle‐closure glaucoma
3.11.2 Informed consent
Example 3.25 Protocol SQGL02 (1999): Brimonidine as a neuroprotective agent in acute angle‐closure glaucoma
Example 3.26 eConsent – acute stroke
3.12 Organisational structure
3.13 Publication policy
Example 3.27 Protocol SQOLP01: Comparison of steroid with cyclosporine for the topical treatment of oral lichen planus PUBLICATION POLICY
3.14 Trial forms
3.15 Appendices
3.16 Regulatory requirements
3.16.1 Protocol amendments
3.17 Guidelines
3.18 Protocols
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