Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 20 of 37 for “"Clinical trial design"”.
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Bayesian Adaptive Clinical Trial Design
… chemotherapeutic agents, making the conventional trial design paradigm inefficient and dysfunctional. Specifically, the focus of dose-finding trials has shifted from finding the maximum tolerated dose (MTD) to the optimal biological dose (OBD), defined as the dose that optimizes the risk–benefit …
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Challenges facing clinical trial design in oncology
Background: Clinical trials are designed to help patients to live better and/or longer. Each component considered in the design of the trial has the potential to shape and impact the ultimate result. Interpretation of a trial as positive or negative hinges on the endpoint of interest and the trial …
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Deep learning methods for clinical trial design, execution, and analysis
Submission original under an indefinite embargo labeled 'Open Access'. The submission was exported from vireo on 2025-10-19 without embargo terms
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Innovative Alzheimer's disease clinical trial design in the coming age of biomarkers
… drugs in recent years, the length of AD clinical trials has tripled and the enrollment has gone up drastically. These investigational disease-modifying drugs address new targets including the amyloid beta and tau protein aggregation pathways in the brain. They have opened up a whole …
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Novel combination strategies with Aurora Kinase Inhibitors: using pre-clinical data to guide clinical trial design
… drugs with aurora kinase inhibitors (AKI) in pre-clinical models and then to design a clinical trial to assess these in patients with bladder cancer. Particular interest was stimulated by the correlation between over-expression of aurora kinases (AKs) with aggressive clinical behaviour in many …
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Age-Dependent Variability in Immune Host Responses to SARS-CoV-2: Implications for Inclusive Clinical Trial Design
… of older adults in COVID-19 vaccine clinical trials to assess whether key age-associated immune differences are being adequately captured in clinical research. In Chapter 1, we examined the effects of IFNβ pre-treatment on SARS-CoV-2 infection dynamics in lung epithelial cell models. …
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Topics in Bayesian adaptive clinical trial design using dynamic linear models and missing data imputation in logistic regression.
Conventional Phase II clinical trial designs usually employ a logistic regression model to analyze the efficacy of a new drug and, therefore, assumes monotone dose-response relationship. Also, the logistic regression model requires the response to be categorical and, thus, it is not applicable for …
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Improving Outcomes for People Living With Unrelieved Neuropathic Cancer Pain - Understanding the Epidemiology, Patient Experience and Optimal Clinical Trial Design: The INCEPT Mixed Methods Project
… cancer pain, and a pilot randomised controlled trial of lidocaine infusion with an embedded semi-structured interview sub-study of trial feasibility and acceptability. Mid-study and end-study meta-inferences integrated the results. 𝗙𝗶𝗻𝗱𝗶𝗻𝗴𝘀 Distress from unrelieved neuropathic cancer pain is …
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Modified 3+3 Design for MTD Re-estimation
The 3+3 clinical trial design is one of the most popular dose-finding designs used in phase I oncology trials to identify the maximum tolerated dose (MTD) for new treatment regimens. While this design is widely used due to its simplicity , it has some notable limitations, including a maximum of six …
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Changes in the characteristics of approved New Drug Applications for antihypertensives
… the backdrop for my effort to investigate how clinical trial design has evolved for antihypertensive drug submissions reviewed and approved by the Food and Drug Administration between 1988 and 2001. To do this, I have constructed and undertaken a preliminary analysis of a number of quantitative …
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Predicting progressions and clinical subtypes of Alzheimer’s disease using machine learning
… present in the disease progression stages. The clinical symptoms of AD show marked variability in terms of patients’ age, disease span, progression velocity and types of memory, cognitive and depression related features. Hence, the idea of personalized clinical care, with individualized risk, …
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STATIC AND DYNAMIC FORMS TO IDENTIFY DDI POTENTIAL AND SOURCES OF PHARMACOKINETIC VARIABILITY
… to market, a rigorous process comprised of preclinical and clinical assessments is completed to determine various aspects of drug safety and efficacy. These studies are conducted strategically to ensure that company time and resources are optimized. An example of one of many static approaches …
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Investigating the Mechanisms of Resistance to Dual PI3K/MTOR Inhibitor in PIK3CA Mutant Basal Like Bladder Cancer
… and thereby provide patients with maximal clinical benefit. Using two MIBC patient derived xenograft models (PDX) that carry alterations in PI3K signaling, one of the most dysregulated signaling pathways in bladder cancer, we studied determinants of response to PI3K targeted inhibition and …
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Improving outcome assessment for clinical trials in stroke
Abstract Clinical trials are at the centre of advances in our understanding of stroke and its optimal treatment. In this thesis the uses and properties of outcome assessment scales for stroke trials are described, with particular attention given to the modified Rankin Scale (mRS). Through …
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Evaluating Digital Health Technologies to Advance Parkinson's Disease Care
… to identify and monitor symptoms in both a clinical and research context. These included: 1. The evaluation of a computerised paced finger tapping task (PFT) that was found to correlate with a measure of verbal fluency, suggesting there may be potential to implement the PFT as part of a …
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Effects of Perfusate Composition (Na+ and Ca2+) on Cardiac Electrical and Mechanical Function in the Isolated Langendorff-Perfused Heart
… reports, the high attrition rate observed in clinical trials has been attributed to irreproducibility at the preclinical level. Cardiology is no exception to this rule. In our systematic review of the ex vivo Langendorff-perfused heart, we found methods reporting to be sparse at best, …
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Application of machine learning to the detection and prediction of Parkinson’s disease subtypes
Background: The clinical manifestations of Parkinson’s disease (PD) are characterized by heterogeneity in age at onset, disease duration, rate of progression, and the constellation of motor versus non-motor features. As such, counseling of patients about their prognosis is guarded. Characterization …
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AI-Based Speech Assessment of Cognitive Impairment Disorders
… artificial intelligence to improve human health, clinical trial design, and drug development.
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Identification of Novel Fluid Biomarkers for Alzheimer's Disease
… be invaluable for patient care and efficient clinical trial design. To discover such biomarkers, we measured AD-associated changes in the cerebrospinal fluid: CSF) using an unbiased proteomics approach: two-dimensional difference gel electrophoresis with liquid chromatography tandem mass …
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Novel methods for early phase clinical trials
Early phase clinical trials are conducted with limited time and patient resources. Despite design restrictions, patient safety must be prioritised and trial conclusions must be accurate; maximising a promising treatment’s chance of success in later largescale, long-term trials. Increasing the …
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