The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials

Author: National Research Council

Publisher: National Academies Press

Published: 2010-12-21

Total Pages: 163

ISBN-13: 030918651X

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Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.


Evaluating Programs to Increase Student Achievement

Evaluating Programs to Increase Student Achievement

Author: Martin H. Jason

Publisher: Corwin Press

Published: 2008-03-27

Total Pages: 209

ISBN-13: 1452211426

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This updated edition on evaluating the effectiveness of school programs provides an expanded needs-assessment section, additional methods for data analysis, and tools for communicating program results.


Early Phase Drug Evaluation in Man

Early Phase Drug Evaluation in Man

Author: O'grady

Publisher: CRC Press

Published: 1990-09-05

Total Pages: 756

ISBN-13: 9780849377082

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Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.


Clinical Practice Guidelines

Clinical Practice Guidelines

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1990-02-01

Total Pages: 169

ISBN-13: 0309043468

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The Alberta clinical practice guidelines program is supporting appropriate, effective and quality medical care in Alberta through promotion, development and implementation of evidence-based clinical practice guidelines.


Drug Safety Evaluation

Drug Safety Evaluation

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2016-11-18

Total Pages: 918

ISBN-13: 1119097401

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This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition


Environmental Site Assessment Phase I

Environmental Site Assessment Phase I

Author: Kathleen Hess-Kosa

Publisher: CRC Press

Published: 2007-11-26

Total Pages: 314

ISBN-13: 0849379679

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Extensively updated, this third edition provides a valuable guide to the tools and techniques used to perform Phase 1 site assessment. This book elucidates the systematic processes and methods used by leaders in the industry. It also emphasizes the development of an easy-to-follow investigative strategy for in-house assessment. After reviewing the history of the field, legal issues, and important terms, the book discusses physical setting, historic usage, property and area reconnaissance, building materials, and industrial activities associated with a property. It also gives interviewing tips, lists regulatory agencies, and considers unique situations such as wetlands and historical buildings.


Improving the Utility and Translation of Animal Models for Nervous System Disorders

Improving the Utility and Translation of Animal Models for Nervous System Disorders

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2013-04-25

Total Pages: 111

ISBN-13: 0309266335

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Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.


Evaluating AIDS Prevention Programs

Evaluating AIDS Prevention Programs

Author: National Research Council

Publisher: National Academies Press

Published: 1991-02-01

Total Pages: 391

ISBN-13: 030904281X

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With insightful discussion of program evaluation and the efforts of the Centers for Disease Control, this book presents a set of clear-cut recommendations to help ensure that the substantial resources devoted to the fight against AIDS will be used most effectively. This expanded edition of Evaluating AIDS Prevention Programs covers evaluation strategies and outcome measurements, including a realistic review of the factors that make evaluation of AIDS programs particularly difficult. Randomized field experiments are examined, focusing on the use of alternative treatments rather than placebo controls. The book also reviews nonexperimental techniques, including a critical examination of evaluation methods that are observational rather than experimentalâ€"a necessity when randomized experiments are infeasible.