Data and Safety Monitoring Committees in Clinical Trials, Second Edition


Author: Jay Herson
Publisher: CRC Press
ISBN: 1351722379
Category: Mathematics
Page: 241
View: 2304

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Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician ? In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. ? New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members ? Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry. ? ? ? ? ? ? ? ? ? ? ? ? ?

Data and Safety Monitoring Committees in Clinical Trials, Second Edition


Author: Jay Herson
Publisher: CRC Press
ISBN: 1498784127
Category: Mathematics
Page: 241
View: 5494

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Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician ? In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. ? New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members ? Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry. ? ? ? ? ? ? ? ? ? ? ? ? ?

Randomized Phase II Cancer Clinical Trials


Author: Sin-Ho Jung
Publisher: CRC Press
ISBN: 143987185X
Category: Mathematics
Page: 244
View: 8715

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In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biostatisticians have begun to use a randomized phase II trial that compares an experimental therapy with a prospective control therapy. Randomized Phase II Cancer Clinical Trials explains how to properly select and accurately use diverse statistical methods for designing and analyzing phase II trials. The author first reviews the statistical methods for single-arm phase II trials since some methodologies for randomized phase II trials stem from single-arm phase II trials and many phase II cancer clinical trials still use single-arm designs. The book then presents methods for randomized phase II trials and describes statistical methods for both single-arm and randomized phase II trials. Although the text focuses on phase II cancer clinical trials, the statistical methods covered can also be used (with minor modifications) in phase II trials for other diseases and in phase III cancer clinical trials. Suitable for cancer clinicians and biostatisticians, this book shows how randomized phase II trials with a prospective control resolve the shortcomings of traditional single-arm phase II trials. It provides readers with numerous statistical design and analysis methods for randomized phase II trials in oncology.

Adaptive Design Methods in Clinical Trials, Second Edition


Author: Shein-Chung Chow,Mark Chang
Publisher: CRC Press
ISBN: 1439839883
Category: Mathematics
Page: 374
View: 6555

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With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Second Edition Along with revisions throughout the text, this edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives. Following in the tradition of its acclaimed predecessor, this second edition continues to offer an up-to-date resource for clinical scientists and researchers in academia, regulatory agencies, and the pharmaceutical industry. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.

Fundamental Concepts for New Clinical Trialists


Author: Scott Evans,Naitee Ting
Publisher: CRC Press
ISBN: 1498767109
Category: Mathematics
Page: 348
View: 4511

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Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

JASA


Author: N.A
Publisher: N.A
ISBN: N.A
Category: Statistics
Page: N.A
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Der Gott der Alpträume

Roman
Author: Paula Fox
Publisher: C.H.Beck
ISBN: 3406625320
Category: Fiction
Page: 287
View: 9860

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Im Jahre 1941, kurz nachdem ihr Vater, der die Familie schon vor langer Zeit verlassen hat, gestorben ist, verläßt Helen Bynum zum ersten Mal ihren kleinen Heimatort im Staat New York und reist nach New Orleans. Helen ist erst dreiundzwanzig, und voller Staunen, Liebe und Verwunderung, überrascht, manchmal auch schockiert oder ängstlich beobachtet sie das Leben in New Orleans und vor allem in den Bohemienkreisen, in die sie gerät. Helen ist die unschuldigste, offenste Figur, die Paula Fox beschrieben hat, und «Der Gott der Alpträume» ist ihr zärtlichster Roman.

Health technology assessment

Konzepte, Methoden, Praxis für Wissenschaft und Entscheidungsfindung
Author: Matthias Perleth,Reinhard Busse
Publisher: MWV
ISBN: 3939069221
Category: Medical
Page: 259
View: 7675

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Methodik klinischer Studien

Methodische Grundlagen der Planung, Durchführung und Auswertung
Author: Martin Schumacher,Gabriele Schulgen-Kristiansen
Publisher: Springer-Verlag
ISBN: 3662087197
Category: Medical
Page: 377
View: 9221

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Das Buch bietet eine praxisorientierte Einführung in die methodischen Grundlagen klinischer Studien in der wissenschaftlichen Forschung und der pharmazeutischen Industrie. Die grundlegenden Prinzipien der Planung und Durchführung klinischer Studien sowie die wichtigsten statistischen Verfahren für deren Auswertung werden in verständlicher Weise dargestellt und erklärt. Neben der Methodik für Therapiestudien werden auch die speziellen Verfahren in Diagnose- und Prognosestudien behandelt. Anhand von Beispielen konkreter Studien, vorwiegend aus dem Arbeitsumfeld der Autoren, werden die Prinzipien und Methoden anschaulich illustriert und die in der Praxis auftretenden Probleme exemplarisch aufgezeigt. Historische Entwicklungen sowie die aktuellen Anforderungen an die Qualität klinischer Studien werden dargestellt und diskutiert. Das Buch richtet sich an alle, die klinische Studien planen, durchführen und statistisch auswerten.

Statistik

Der Weg zur Datenanalyse
Author: Ludwig Fahrmeir,Christian Heumann,Rita Künstler,Iris Pigeot,Gerhard Tutz
Publisher: Springer-Verlag
ISBN: 3662503727
Category: Mathematics
Page: 581
View: 2428

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Das Buch bietet eine umfassende Einführung in die Statistik. Die Autoren liefern eine integrierte Darstellung der deskriptiven Statistik, der modernen Methoden der explorativen Datenanalyse und der induktiven Statistik, einschließlich der Regressions- und Varianzanalyse. Zahlreiche Beispiele mit realen Daten veranschaulichen den Text. Geeignet als vorlesungsbegleitender Text, aber auch zum Selbststudium für Studierende der Wirtschafts- und Sozialwissenschaften sowie anderer Anwendungsdisziplinen und als Einführung für Studenten der Statistik.

Angewandte Statistik

Anwendung statistischer Methoden
Author: Lothar Sachs
Publisher: Springer-Verlag
ISBN: 3662057506
Category: Mathematics
Page: 887
View: 8893

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Das Nachschlagewerk der Wahl für alle, die Daten gewinnen, beschreiben und beurteilen müssen. - Einfache Beispiele und gebrauchsfertige Anleitungen - Anschauliches Bildmaterial - Übersichtlich und praxisbezogen Die optimale Ergänzung zu jedem Statistik-Software-Handbuch.

Der Meskalinrausch

Seine Geschichte und Erscheinungsweise
Author: K. Beringer
Publisher: Springer-Verlag
ISBN: 3662114518
Category: Medical
Page: 315
View: 3310

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Dieser Buchtitel ist Teil des Digitalisierungsprojekts Springer Book Archives mit Publikationen, die seit den Anfängen des Verlags von 1842 erschienen sind. Der Verlag stellt mit diesem Archiv Quellen für die historische wie auch die disziplingeschichtliche Forschung zur Verfügung, die jeweils im historischen Kontext betrachtet werden müssen. Dieser Titel erschien in der Zeit vor 1945 und wird daher in seiner zeittypischen politisch-ideologischen Ausrichtung vom Verlag nicht beworben.

Synthetisches Repertorium

Gemüts- und Allgemeinsymptome der homöopathischen Materia Medica
Author: Horst Barthel
Publisher: Georg Thieme Verlag
ISBN: 9783830470014
Category:
Page: 676
View: 7713

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