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Yes / We defined disease-modification interventions as those aiming to change the underlying pathology. We systematically searched electronic databases and previous systematic reviews for published and ongoing trials of disease-modifying treatments in mild-to-moderate dementia. We included 149/22,918 of the references found; with 81 outcome measures from 125 trials. Trials involved participants with Alzheimer's disease (AD) alone (n = 111), or AD and mild cognitive impairment (n = 8) and three vascular dementia. We divided outcomes by the domain measured (cognition, activities of daily living, biological markers, neuropsychiatric symptoms, quality of life, global). We calculated the number of trials and of participants using each outcome. We detailed psychometric properties of each outcome. We sought the views of people living with dementia and family carers in three cities through Alzheimer's society focus groups. Attendees at a consensus conference (experts in dementia research, disease-modification and harmonisation measures) decided on the core set of outcomes using these results. Recommended core outcomes were cognition as the fundamental deficit in dementia and to indicate disease modification, serial structural MRIs. Cognition should be measured by Mini Mental State Examination or Alzheimer's Disease Assessment Scale-Cognitive Subscale. MRIs would be optional for patients. We also made recommendations for measuring important, but non-core domains which may not change despite disease modification. / The National Institute for Health Research Health Technology Assessment programme

Complete randomized experimental design has been a popular standard in clinical trials due to its abilities to yield a smaller bias and to provide a strong foundation for statistical inferences. However, because of ethical issues, there is a growing demand for response adaptive designs which shift the allocation probabilities such that more patients receive the better treatment. The principal idea of response adaptive designs to allocate fewer patients to treatments which appears to be inferior based on the accruing response data and information collected up to the current stage. Although they are more complex than complete randomized experiments in theory and method, adaptive designs are practically more useful. The objective of this dissertation is to develop an adaptive design, the generalized drop-the-loser rule, for comparing multiple treatments in clinical trials, including the situation where the responses of patients are delayed moderately. Asymptotic properties including strong consistency and asymptotic normality of the new design are investigated through the martingale technique. Monte Carlo simulation studies are conducted to reveal the empirical performance of this design. The new design will be potentially useful in the practical context of clinical trials. / Sun Ruibo. / "July 2006." / Adviser: Siu Hung Cheung. / Source: Dissertation Abstracts International, Volume: 67-11, Section: B, page: 6488. / Thesis (Ph.D.)--Chinese University of Hong Kong, 2006. / Includes bibliographical references (p. 62-66). / Electronic reproduction. Hong Kong : Chinese University of Hong Kong, [2012] System requirements: Adobe Acrobat Reader. Available via World Wide Web. / Electronic reproduction. [Ann Arbor, MI] : ProQuest Information and Learning, [200-] System requirements: Adobe Acrobat Reader. Available via World Wide Web. / Abstracts in English and Chinese. / School code: 1307.

MSc (Med), Pharmaceutical Affairs, Faculty of Health Sciences, University of the Witwatersrand / Quality Assurance (QA) Audits are an essential component and an integral part of clinical trials. As a quality improvement tool, forming part of Good Clinical Practice (GCP) an audit can demonstrate that real efforts are being made to improve and enhance the quality of professional care to all trial subjects participating in clinical trials. Specifically, clinical research performed on the central nervous system (CNS) involves distinctive areas of concern to adherence to good clinical practice in this therapeutic area. For example an informed consent process not conducted appropriately for subjects with e.g. Schizophrenia or Alzheimer’s disease; or inter-individual rating differences in instances when different investigators (psychiatrist) assess a trial subject. A need was identified to analyze the association between the CNS indication audited and the audit findings and to perform a trend analysis that highlight re-occuring audit findings. A total of 123 CNS audit reports were obtained from the Quality Assurance Departments of Quintiles in South Africa and Europe. The audit reports were grouped into the 15 CNS indications that were audited. Five hundred and six (506) audit findings were derived from the 123 CNS audits reports. The audit findings were categorized according to GCP subject matter, regulatory requirements or Standard Operating Procedures (SOPs). The severity of audit findings was classified as critical or major. The results of this investigation suggested a need for substantial improvement in three important areas. Firstly; adherence to the study requirements inclusive of relevant Standard Operating Procedures (SOPs). Secondly the development of better defined protocols and thirdly training of monitors. Study planners and Clinical Trial Management should take a proactive role to minimize the audit findings by ensuring monitors with experience in the research field should be involved in the study. Procedures should be implemented to educate site staff. Focus should be placed on the importance of detailed source documentation, adherence to investigational product dosage requirements, the conduct of the informed consent process, and adequate study documentation maintenance.

Thesis (Ph.D.)--Bowling Green State University, 2008. / Document formatted into pages; contains viii, 301 p. Includes bibliographical references.

Thesis (Ph. D.)--University of California, San Diego, 1999. / Vita. Includes bibliographical references (leaves 361-393).

Thesis (Ph. D.)--Pardee RAND Graduate School, 2004. / Includes bibliographical references.

Thesis (doctoral)--Universität München, 1934. / At head of title: Aus der Abteilung für Zahn- und Kieferersatz ... des Zahnärtzlichen Instituts der Universität München. "Lebenslauf": p. 5. Includes bibliographical references.