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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report

In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM;

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Rational Therapeutics for Infants and Children

, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop;

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Improving the Quality of Cancer Clinical Trials

clinical trials, while maintaining the highest standards of quality. To explore innovative paradigms for cancer clinical trials and other ways to;

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Neuroscience Trials of the Future

validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including;

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Data Monitoring Committees in Clinical Trials

decision-making. * Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees;

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Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and;

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The Clinical Audit in Pharmaceutical Development

This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the;

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The Clinical Audit in Pharmaceutical Development

This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the;

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Large Simple Trials and Knowledge Generation in a Learning Health System

inform medical decision making and medical product development. Although well-designed and -implemented clinical trials can provide robust;

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Clinical Trials In Osteoporosis

include study design, technical issues, data collection, quality assurance, data analysis, and presentation. Clinical Trials in Osteoporosis takes;

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials

of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are;

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Implementing a National Cancer Clinical Trials System for the 21st Century

Implementing a National Cancer Clinical Trials System for the 21st Century References Acronyms Appendix A: Workshop Statement of Task and Agenda;

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Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020

timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming;

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Clinical Trials in Osteoporosis

study design, technical issues, data collection, quality assurance, data analysis and presentation. It aims to take the user through the process;

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Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda

implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory;

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Improving and Accelerating Therapeutic Development for Nervous System Disorders

validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug;

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Oncology Clinical Trials

data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials;

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Design and Analysis of Quality of Life Studies in Clinical Trials

More and more frequently, clinical trials include the evaluation of Health-Related Quality of Life (HRQoL), yet many investigators remain;

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Statistical Approaches in Oncology Clinical Development

is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences;

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Management Of Data In Clinical Trials

, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials;

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Exploring Challenges, Progress, and New Models for Engaging the Public in the Clinical Research Enterprise

adequately trained workforce; and ensuring adequate funding for clinical research. In addition, the report identifies two translational blocks-from;

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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups

of Cooperative Group Clinical Trials Summary and Wrap-Up References Abbreviations and Acronyms Glossary Appendix A: Workshop Agenda Appendix B;

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Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement

of trial design, case report form design, quality of life measures, sample sizes, submissions to regulatory authorities for reimbursement, Markov;

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Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement

of trial design, case report form design, quality of life measures, sample sizes, submissions to regulatory authorities for reimbursement, Markov;

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The Value of Innovation

treatment of chronic conditions. It emphasises effective quality, regulatory system, and consistent science-based decision-making practices from;

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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

There is currently limited acceptance of foreign clinical data by regulatory authorities, although the reasons for repeating studies are;

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Quality of Life and Pharmacoeconomics in Clinical Trials

redefines the role of these evaluation parameters in clinical trials and health care decision-making. Dr. Spilker has assembled more than 200;

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