Statistical aspects of clinical trials
Statistical aspects of clinical trials
This thesis presents a book and a collection of published papers concerned with statistical aspects of clinical trials. It is divided into six chapters emphasising design, the protocol, quality control, analysis, prognosis and statistical theory.
3OC
The design section is mainly concerned with the estimation of patient numbers required for a randomised trial in order to detect a pre-specified clinically worthwhile difference between treatments for a given test size and power. It includes corresponding tables for sample sizes.
Several examples of summary protocols and papers on organisational, data management and analysis aspects of clinical trials are included. Two papers describe the evolution of checklists for the assessment of the statistical quality of the design of clinical studies and their reporting.
The results of cancer therapy trials, the effect of ultrasound on pressure sores, the evaluation of health education material and compliance with screening for colorectal cancer are described. Particular emphasis is placed on randomised trials of alternative therapies, including acupuncture and transcutaneous nerve stimulation, for the relief of chronic pain. The majority of these latter trials failed to achieve anticipated pre-trial efficacy for the active treatment
Prognostic factors are identified for gastro-intestinal lymphoma, the myelodysplastic syndromes and low back pain and sciatica.
Theoretical papers describing the advantages of multi-centre as opposed to single centre trials, the possibility of incorporating non-randomised patients into a randomised trial, estimating the proportion of cured patients in cancer trials and the extension of a decision theoretic model for selecting medical treatments as an alternative to the classical randomised control trial are presented.
University of Southampton
Machin, David
c21de63c-98a1-438e-bb3a-838574bb3e7a
1983
Machin, David
c21de63c-98a1-438e-bb3a-838574bb3e7a
Machin, David
(1983)
Statistical aspects of clinical trials.
University of Southampton, Doctoral Thesis.
Record type:
Thesis
(Doctoral)
Abstract
This thesis presents a book and a collection of published papers concerned with statistical aspects of clinical trials. It is divided into six chapters emphasising design, the protocol, quality control, analysis, prognosis and statistical theory.
3OC
The design section is mainly concerned with the estimation of patient numbers required for a randomised trial in order to detect a pre-specified clinically worthwhile difference between treatments for a given test size and power. It includes corresponding tables for sample sizes.
Several examples of summary protocols and papers on organisational, data management and analysis aspects of clinical trials are included. Two papers describe the evolution of checklists for the assessment of the statistical quality of the design of clinical studies and their reporting.
The results of cancer therapy trials, the effect of ultrasound on pressure sores, the evaluation of health education material and compliance with screening for colorectal cancer are described. Particular emphasis is placed on randomised trials of alternative therapies, including acupuncture and transcutaneous nerve stimulation, for the relief of chronic pain. The majority of these latter trials failed to achieve anticipated pre-trial efficacy for the active treatment
Prognostic factors are identified for gastro-intestinal lymphoma, the myelodysplastic syndromes and low back pain and sciatica.
Theoretical papers describing the advantages of multi-centre as opposed to single centre trials, the possibility of incorporating non-randomised patients into a randomised trial, estimating the proportion of cured patients in cancer trials and the extension of a decision theoretic model for selecting medical treatments as an alternative to the classical randomised control trial are presented.
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Published date: 1983
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Local EPrints ID: 460792
URI: http://eprints.soton.ac.uk/id/eprint/460792
PURE UUID: 5bb47589-0cd7-4125-8cd6-cafb09ca7e1d
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Date deposited: 04 Jul 2022 18:29
Last modified: 23 Jul 2022 00:58
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Author:
David Machin
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