Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials

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Publisher : CRC Press
ISBN 13 : 1351214527
Total Pages : 218 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials by : Mark Chang

Download or read book Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials written by Mark Chang and published by CRC Press. This book was released on 2019-03-20 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Modern Things on Trial

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Publisher :
ISBN 13 : 9780231188678
Total Pages : 384 pages
Book Rating : 4.1/5 (886 download)

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Book Synopsis Modern Things on Trial by : Leor Halevi

Download or read book Modern Things on Trial written by Leor Halevi and published by . This book was released on 2020-12-15 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leor Halevi tells the story of the Islamic trials of technological and commercial innovations of the late nineteenth and early twentieth centuries. Shedding light on culture, commerce, and consumption in Cairo and other colonial cities, Modern Things on Trial is a groundbreaking account of Islam's material transformation in a globalizing era.

Modern Trials

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (82 download)

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Book Synopsis Modern Trials by : Melvin M. Belli

Download or read book Modern Trials written by Melvin M. Belli and published by . This book was released on 1982 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Modern Adaptive Randomized Clinical Trials

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Publisher : CRC Press
ISBN 13 : 1482239892
Total Pages : 536 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Modern Adaptive Randomized Clinical Trials by : Oleksandr Sverdlov

Download or read book Modern Adaptive Randomized Clinical Trials written by Oleksandr Sverdlov and published by CRC Press. This book was released on 2015-06-30 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive random

Modern Trials

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Publisher :
ISBN 13 :
Total Pages : 832 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Modern Trials by : Melvin M. Belli

Download or read book Modern Trials written by Melvin M. Belli and published by . This book was released on 1982 with total page 832 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Small Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Masculinity and the Trials of Modern Fiction

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Publisher : Routledge
ISBN 13 : 1134843879
Total Pages : 298 pages
Book Rating : 4.1/5 (348 download)

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Book Synopsis Masculinity and the Trials of Modern Fiction by : Marco Wan

Download or read book Masculinity and the Trials of Modern Fiction written by Marco Wan and published by Routledge. This book was released on 2016-11-10 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: How do lawyers, judges and jurors read novels? And what is at stake when literature and law confront each other in the courtroom? Nineteenth-century England and France are remembered for their active legal prosecution of literature, and this book examines the ways in which five novels were interpreted in the courtroom: Gustave Flaubert’s Madame Bovary, Paul Bonnetain’s Charlot s’amuse, Henry Vizetelly’s English translation of Émile Zola’s La Terre, Oscar Wilde’s The Picture of Dorian Gray and Radclyffe Hall’s The Well of Loneliness. It argues that each of these novels attracted legal censure because they presented figures of sexual dissidence – the androgyne, the onanist or masturbator, the patricide, the homosexual and the lesbian – that called into question an increasingly fragile normative, middleclass masculinity. Offering close readings of the novels themselves, and of legal material from the proceedings, such as the trial transcripts and judicial opinions, the book addresses both the doctrinal dimensions of Victorian obscenity and censorship, as well as the reading practices at work in the courtroom. It situates the cases in their historical context, and highlights how each trial constitutes a scene of reading – an encounter between literature and the law – through which different forms of masculinity were shaped, bolstered or challenged.

Modern Trials

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (869 download)

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Book Synopsis Modern Trials by : Melvin M. Belli

Download or read book Modern Trials written by Melvin M. Belli and published by . This book was released on 1954 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Modern Trials

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Publisher :
ISBN 13 : 9781258083441
Total Pages : 960 pages
Book Rating : 4.0/5 (834 download)

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Book Synopsis Modern Trials by : Melvin M. Belli

Download or read book Modern Trials written by Melvin M. Belli and published by . This book was released on 2011-08-01 with total page 960 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Modern Trials

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (12 download)

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Book Synopsis Modern Trials by : Melvin M. Belli

Download or read book Modern Trials written by Melvin M. Belli and published by . This book was released on 1954 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Neuroscience Trials of the Future

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Publisher : National Academies Press
ISBN 13 : 0309442583
Total Pages : 111 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Neuroscience Trials of the Future by : National Academies of Sciences, Engineering, and Medicine

Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Virtual Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 0309494885
Total Pages : 127 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Virtual Clinical Trials by : National Academies of Sciences, Engineering, and Medicine

Download or read book Virtual Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-11-16 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Modern Trials, V5

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Publisher :
ISBN 13 : 9781258078102
Total Pages : 1022 pages
Book Rating : 4.0/5 (781 download)

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Book Synopsis Modern Trials, V5 by : Marvin M. Belli

Download or read book Modern Trials, V5 written by Marvin M. Belli and published by . This book was released on 2011-08-01 with total page 1022 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Modern Trial Advocacy

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Publisher : Aspen Publishing
ISBN 13 : 1601568274
Total Pages : 484 pages
Book Rating : 4.6/5 (15 download)

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Book Synopsis Modern Trial Advocacy by : Steven Lubet

Download or read book Modern Trial Advocacy written by Steven Lubet and published by Aspen Publishing. This book was released on 2019-07-28 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its fourth edition, Modern Trial Advocacy: Canada is the first and last word in Canadian trial practice. This classic handbook, published by the National Institute for Trial Advocacy, gives practitioners a detailed road map for conducting a trial. Expanding on the original text written by Steven Lubet for an American audience, experienced Toronto trial lawyers Cynthia Tape and Julie Rosenthal guide the beginning advocate in developing a winning case theory through all phases of trial. They explain how to present a case as a story – and powerfully and persuasively tell that story to the jury. Modern Trial Advocacy: Canada provides not only Canadian case law and statutes, but also valuable insight into the specific elements of Canadian litigation practice as itpresents a realistic and contemporary approach to learning and developing trial advocacy skills. This book offers a sophisticated, theory-driven approach to advocacy training that distinguishes it from other books in the field. The fourth edition has been updated with current citations to case law, statutes, and rules and the latest “best practices” for using technology in the courtroom.

Novel Designs of Early Phase Trials for Cancer Therapeutics

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Publisher : Academic Press
ISBN 13 : 0128125705
Total Pages : 235 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Novel Designs of Early Phase Trials for Cancer Therapeutics by : Shivaani Kummar

Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar and published by Academic Press. This book was released on 2018-05-22 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

Cautio Criminalis, or a Book on Witch Trials

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Publisher : University of Virginia Press
ISBN 13 : 0813934176
Total Pages : 413 pages
Book Rating : 4.8/5 (139 download)

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Book Synopsis Cautio Criminalis, or a Book on Witch Trials by : Friedrich Spee

Download or read book Cautio Criminalis, or a Book on Witch Trials written by Friedrich Spee and published by University of Virginia Press. This book was released on 2012-10-05 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1631, at the epicenter of the worst excesses of the European witch-hunts, Friedrich Spee, a Jesuit priest, published the Cautio Criminalis, a book speaking out against the trials that were sending thousands of innocent people to gruesome deaths. Spee, who had himself ministered to women accused of witchcraft in Germany, had witnessed firsthand the twisted logic and brutal torture used by judges and inquisitors. Combined, these harsh prosecutorial measures led inevitably not only to a confession but to denunciations of supposed accomplices, spreading the circle of torture and execution ever wider. Driven by his priestly charge of enacting Christian charity, or love, Spee sought to expose the flawed arguments and methods used by the witch-hunters. His logic is relentless as he reveals the contradictions inherent in their arguments, showing there is no way for an innocent person to prove her innocence. And, he questions, if the condemned witches truly are guilty, how could the testimony of these servants and allies of Satan be reliable? Spee’s insistence that suspects, no matter how heinous the crimes of which they are accused, possess certain inalienable rights is a timeless reminder for the present day. The Cautio Criminalis is one of the most important and moving works in the history of witch trials and a revealing documentation of one man’s unexpected humanity in a brutal age. Marcus Hellyer’s accessible translation from the Latin makes it available to English-speaking audiences for the first time. Studies in Early Modern German History

Modern Jury Trials and Advocates

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Publisher :
ISBN 13 :
Total Pages : 750 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Modern Jury Trials and Advocates by : Joseph W. Donovan

Download or read book Modern Jury Trials and Advocates written by Joseph W. Donovan and published by . This book was released on 1914 with total page 750 pages. Available in PDF, EPUB and Kindle. Book excerpt: