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List of Illustrations

1 Chapter 1Figure 1.1 Individual patient reductions in disease activity (SASSAD) for th...Figure 1.2 The relative strength of evidence obtained from alternative desig...Figure 1.3 Special considerations for clinical trials in human subjects Figure 1.4 Avicenna’s rules for the experimental use and testing of drugs Figure 1.5 Sequential phases of developing randomised controlled trials of c...
2 Chapter 2Figure 2.1 Individually randomised controlled trial of the effect of topical...
3 Chapter 3Figure 3.1 Major components of a clinical trial protocol Figure 3.2 Part of the Information Sheet utilised in the multicentre COMPLIA...Figure 3.3 Consent form designed to obtain assent from a patient to be rando...
4 Chapter 4Figure 4.1 Selected baseline, adverse event and endpoint results from a tria...Figure 4.2 Skin assessment scale used for the grading of pressure sores.Figure 4.3 Batch baseline mean and SD of estrone levels, and corresponding Z Figure 4.4 Registration form.Figure 4.5 Surgical complications form.Figure 4.6 Follow‐up form.Figure 4.7 Part of the Questionnaire (SVQ) for self‐assessment of sexual fun...Figure 4.8 General health question from SF‐36v2.
5 Chapter 5Figure 5.1 All possible permutations of block size 4 for two treatments A an...Figure 5.2 Randomised block design (RBD) for 24 units comprising two interve...Figure 5.3 Randomised block design (RBD) for 18 patients comprising three in...Figure 5.4 All possible permutations of block size 5 for two interventions SFigure 5.5 Stratification groups for a trial for alleviating urinary symptom...Figure 5.6 Distribution of patients with prostate cancer according to TURP a...Figure 5.7 Advantages and disadvantages of different types of randomisation...Figure 5.8 Key steps in preparing the randomisation list for a parallel grou...
6 Chapter 6Figure 6.1 Schematic representation of some stages involved when planning a ...Figure 6.2 Suggested details necessary for trial registration purposes.Figure 6.3 Aspects of the progress of a trial that require internal monitori...
7 Chapter 7Figure 7.1 Problems associated with missing case record forms and data items...
8 Chapter 8Figure 8.1 The probability density function of a standardised Normal distrib...Figure 8.2 Edited commands and output for the analysis of SASSAD reduction i...Figure 8.3 Edited commands and output for the analysis of median SASSAD scor...Figure 8.4 Edited commands and output for the analysis of parasite clearance...Figure 8.5 Investigator assessed response to treatment in patients with mode...Figure 8.6 Edited commands and output for the analysis of the response to tr...Figure 8.7 Edited commands and output for the analysis for calculating the K...Figure 8.8 Kaplan–Meier (K–M) overall survival curves in years of 15 patient...Figure 8.9 Kaplan–Meier (K–M) estimates of overall survival in 50 children w...Figure 8.10 Edited commands and output for the analysis using the logrank te...Figure 8.11 Edited command and output for the analysis from a regression pac...Figure 8.12 Edited commands and output from a regression package used for th...Figure 8.13 Edited commands and output from a regression package using the C...Figure 8.14 Edited commands and output from a statistical package using the ...Figure 8.15 Creating the dummy variables for an unordered categorical variab...Figure 8.16 Edited commands and output from (a) a stratified logrank test an...Figure 8.17 Further analysis of the trial data of Figure 8.5 for SASSAD redu...
9 Chapter 9Figure 9.1 Relationship between Type I and Type II errors and significance t...Figure 9.2 Distribution of under the null and alternative hypothesesFigure 9.3 Comparison of the results from a new diagnostic test against that...Figure 9.4 Sensitivity of two diagnostic tests in detecting any metastatic d...Figure 9.5 Investigator assessed response to treatment in patients with mode...Figure 9.6 Planned confirmatory trial of that conducted by Meggitt, Gray and...Figure 9.7 Components necessary to estimate the size of a comparative trial...Figure 9.8 Interpretation of a planning standardised effect size.
10 Chapter 10Figure 10.1 Key aspects concerning the role of an independent data and safet...Figure 10.2 Example of an interim analysis which would trigger a meeting of ...Figure 10.3 Nominal p‐values for overall test size α = 0.05 for at each...Figure 10.4 Conditional power calculations at each interim analysis of the I...
11 Chapter 11Figure 11.1 Selected key items to be included in a randomised trial report....Figure 11.2 Scenarios for primary endpoint of a randomised trial comparing n...Figure 11.3 Trial profile following the CONSORT guidelines.Figure 11.4 Trial profile following the CONSORT guidelines.Figure 11.5 Demographic and clinical characteristics together with baseline ...Figure 11.6 Table of baseline characteristics illustrating the inappropriate...Figure 11.7 Drug efficacy at 12 weeks in patients with moderate‐to‐severe ec...Figure 11.8 Incidence of adverse events in patients with dyslipidaemia.Figure 11.9 Adverse events and laboratory abnormalities reported in patients...Figure 11.10 Dot plots of severity of diarrhoeal episodes and numbers of sto...Figure 11.11 Survival at 1‐year of mechanically ventilated patients in inten...
12 Chapter 12Figure 12.1 Reported serious adverse events in postmenopausal women with ear...Figure 12.2 Median and range of quality of life (QoL) scores at 4 weeks toge...Figure 12.3 Edited Stata commands and output for the analysis of quality of ...Figure 12.4 Number of patients with 75% reduction in psoriasis at week 12 by...Figure 12.5 Edited Stata command and output for the analysis of the proporti...Figure 12.6 Proportion of patients achieving a 75% reduction in psoriasis at...Figure 12.7 Randomised 2 × 2 factorial trial of diclofenac and spinal manipu...Figure 12.8 All possible permuted blocks of size 4Figure 12.9 Outcome for the proportion of infants with Unilateral Cleft Lip ...Figure 12.10 Edited Stata commands and output for analysing a parallel‐group...
13 Chapter 13Figure 13.1 Spike plots of the VAS profiles of individual patients receiving...Figure 13.2 Results from a matched‐pair design comparing the numbers of pati...Figure 13.3 Edited commands and output for analysing a randomised trial, wit...Figure 13.4 Edited commands and output for analysing a matched‐pair randomis...Figure 13.5 Notation for a matched‐pair design comparing the numbers of pati...Figure 13.6 Edited commands and output from a statistical package for analys...Figure 13.7 General notation for a paired 2 × 2 contingency table comparing ...Figure 13.8 Randomised placebo controlled, two‐period cross‐over trial of an...Figure 13.9 Illustrative example of the analysis of a cross‐over trial.Figure 13.10 Results from a split‐mouth non‐randomised design comparing Glas...Figure 13.11 Edited commands and output from a statistical package for analy...
14 Chapter 14Figure 14.1 Mean 6‐minute walk test (6MWT) values at baseline, 4‐ and 12‐wee...Figure 14.2 Percentage reduction in body surface area (BSA) over time in pat...Figure 14.3 Comparison of 6‐minute walk test between Placebo and FCM using t...Figure 14.4 Comparison of 6‐minute walk test at week 12 post‐randomisation t...Figure 14.5 Mean blood phenylalanine concentration levels pre‐randomisation ...Figure 14.6 Examples of possible auto‐correlation matrix structures arising ...Figure 14.7 Pairwise correlations between 6MWT assessments at baseline, 4 an...Figure 14.8 Mixed models for the 6‐minute walk test (Walk) with random inter...Figure 14.9 Model for the 6‐minute walk test (Walk) comparing with fixed Tre...Figure 14.10 Model for comparing 6‐minute walk test (Walk) values between (f...Figure 14.11 Variation in the values of the design effect of Equation (14.18...Figure 14.12 Structure of the anticipated variance, Var(C) = [SD(C)]², for a...Figure 14.13 Design effects for repeated measure designsFigure 14.14 Variation in sample size for a continuous outcome variable as a...Figure 14.15 Possible tabular presentation of the results from the Kansas Ci...Figure 14.16 Jittered scatter plot of baseline and successive post‐randomisa...Figure 14.17 Individual profiles of the Kansas City Cardiomyopathy Questionn...Figure 14.18 Profiles to illustrate variation in KCCQ of eight selected pati...Figure 14.19 Summary model of change in 6‐minute walk test (6MWT) with P and...
15 Chapter 15Figure 15.1 Hypotheses associated with parallel‐group trials to establish (a...Figure 15.2 Schematic diagram to illustrate the concept of non‐inferiority f...Figure 15.3 Potential results from a two‐period two‐intervention cross‐over ...Figure 15.4 The number of babies that cried during venepuncture from a cross...Figure 15.5 Schematic diagram to illustrate the concept of equivalence by us...
16 Chapter 16Figure 16.1 Number of clusters and the corresponding CV(m) of cluster size b...Figure 16.2 Edited commands and output for the analysis from a hypothetical ...Figure 16.3 Additional items required when specifically reporting cluster‐ra...
17 Chapter 17Figure 17.1 (a) Design characteristics and terminology of a SWD, where shade...Figure 17.2 Schematic repetitions of a cross‐sectional and closed cohort SWDFigure 17.3 (a) Design: SWD with a run‐in assessment of all clusters, follow...Figure 17.4 Planning design characteristics and eventual sample size of the Figure 17.5 The A (=K) by P design matrix, D, for a Full SWD with, b = 1, g ...Figure 17.6 Design matrix, D, corresponding to the full SWD of Figure 17.3a....Figure 17.7 Simplified analysis of a CS‐SWD design comparing the propo...Figure 17.8 The relationships between Time, Period and Arm, in a SWDFigure 17.9 A naïve analysis comparing the proportion of confirmed ischaemic...Figure 17.10 Analysis of a CS‐SWD comparing the proportion of confirme...Figure 17.11 Definition of intra‐class correlation coefficient (ICC), ρFigure 17.12 Examples of the CS‐SWD design matrix, D, with the corresponding...Figure 17.13 CC‐SWD for evaluating a free school breakfast programme i...Figure 17.14 Number of observations, mean and standard deviation of the numb...Figure 17.15 Components of total variance for a CC‐SWD designFigure 17.16 Examples of the CC design matrix D, with the corresponding valu...
18 Chapter 18Figure 18.1 Predictive classifier for randomised trials involving molecular ...Figure 18.2 Enrichment Design (BrichD) in which subjects are selected for ra...Figure 18.3 Randomised Biomarker‐Stratified Design (BstraD)Figure 18.4 Schematic overall survival curves from a BstraD in which the bio...Figure 18.5 Strategies for analysis of a Biomarker‐Stratified Design.Figure 18.6 Anticipate T effective in all (B− and B+) patients: strate...Figure 18.7 Anticipate T effective in B− only if shown effective in B+...Figure 18.8 Decreasing value of HR(B+) (implying increasing effect size) req...Figure 18.9 Anticipate T effective in all (B− and B+) patients: strate...Figure 18.10 Anticipate T effective in B− only if shown effective in BFigure 18.11 Number of chemorefractory non‐small‐cell lung cancer patients r...
19 Chapter 19Figure 19.1 Flat rule‐of‐thumb for the total sample size of a randomised two...Figure 19.2 Stepped rule‐of‐thumb total sample size, N_Pilot, for a two‐equal...Figure 19.3 Vital features of, and consequences from, an Internal‐Pilot stud...
20 Chapter 20Figure 20.1 Potential double triangular sequential design to compare two mat...Figure 20.2 Actual group‐sequential (Christmas tree) design to compare press...Figure 20.3 Sequential trial to compare the addition of lithium carbonate wi...Figure 20.4 Extract from the data generated by the adaptive design of Giles,...Figure 20.5 A rolling randomised trial commencing with a Standard and two te...Figure 20.6 Cumulative Kaplan–Meier curves for the event, cardiovascular dea...Figure 20.7 Illustration of how an external prior and the likelihood distrib...Figure 20.8 Three alpha‐spending functions for interim data monitoring descr...Figure 20.9 Futility analysis assuming 3‐year survival of 60% with surgery a...Figure 20.10 The Zelen single randomised consent design.Figure 20.11 The Zelen double randomised consent design.Figure 20.12 Forest plot following an overview and meta‐analysis of 11 rando...Figure 20.13 Postoperative residual refractive astigmatism at 6 months or mo...
21 AppendixFigure T1 The probability density function of a standardised Normal distribu...Figure T2 The probability density function of the Student's t‐distribution t...

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