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Fundamentals Of Clinical Trials

Author: Lawrence M. Friedman
Publisher: Springer
ISBN: 331918539X
Size: 11.30 MB
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This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.

An Overview Of Clinical Trial Operation

Author: Shibadas Biswal
Publisher: Shibadas Biswal
Size: 17.92 MB
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This book is a must-read for students and professionals for a broad understanding of the entire process of clinical trial operation. In the second edition released in December 2017, we have added several new topics of interest taking the total count to 112. At the moment, a clinical trial is the most relevant method at our disposal to explore and establish safety/efficacy of a new medicine. It is the fundamental basis of clinical development programs of healthcare products. Clinical research has opened up several new career choices. Graduates in medicine, pharmacy, and other life sciences now have the option to work as investigators, scientists, project managers, data managers, monitors, study coordinators, regulatory affairs managers, and so on. Many of these positions have specialized and focused responsibilities in the industry setting. Considering the highly complex environment of clinical research, a broad overview is indispensable for effective collaboration. This book has been written for life science graduates aspiring to work in clinical research industry or clinical research professionals without considerable experience in trial operation. It would also be useful for professionals with focused responsibilities to broaden understanding of the entire gamut of trial operation. As fundamental approach is independent of nature of the investigational product (e.g. drug, device, vaccine or diagnostic agent), we are hopeful of its wider usefulness to the entire healthcare industry. The objective is to provide a broad outline of key activities, principles, roles, and responsibilities without getting into procedural details. Most organizations involved in clinical research have defined processes and procedures to carry out specific responsibilities relevant to their business. Hence, the discussion is purposefully limited to an overview to keep it concise yet informative. Discussion in each topic covers the background, operational overview, and usual challenges. Frequently used terminology has been introduced in the context of specific topics to induce familiarity. The book has been organized into several topics from the perspective of a project manager driving an entire trial. Organization of topics is according to the flow of trial operation from conception to the end. At the outset, the context of different trials according to phases of drug development has been introduced. Subsequent topics are on planning, setup, execution, and closeout in a sequential manner. Towards the end, the topics are on few general aspects of trial operation. This book has been written based on our practical experience, as well as regulatory guidance and other freely accessible literature. Good clinical practice (GCP) lays down the fundamental guiding principles for trial operation. Familiarity with any GCP guidance is highly recommended for the best outcome from this book.

Multiple Analyses In Clinical Trials

Author: Lemuel A. Moyé
Publisher: Springer Science & Business Media
ISBN: 0387218130
Size: 10.89 MB
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Concentrating on the rationale for the analyses, the difficulties posed by their interpretation, easily understood solutions, and useful problem sets, this book will help clinical investigators understand multiple analysis procedures and key issues. It is written for advanced medical students, clinical investigators at all levels, research groups within the pharmaceutical industry, regulators at the local, state, and federal level, and biostatisticians.

Data Monitoring In Clinical Trials

Author: David L. DeMets
Publisher: Springer Science & Business Media
ISBN: 0387301070
Size: 18.46 MB
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From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998. No competition yet as the text does not focus on how to do clinical trials but on very specific situations that can be encountered during the process.

Statistical Monitoring Of Clinical Trials

Author: Lemuel A. Moyé
Publisher: Springer Science & Business Media
ISBN: 038727782X
Size: 73.68 MB
Format: PDF
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Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research efforts. The author provides motivated clinical investigators the background, correct use, and interpretation of these monitoring procedures at an elementary statistical level. He defines terms commonly used such as group sequential procedures and stochastic curtailment in non-mathematical language and discusses the commonly used procedures of Pocock, O’Brien–Fleming, and Lan–DeMets. He discusses the notions of conditional power, monitoring for safety and futility, and monitoring multiple endpoints in the study. The use of monitoring clinical trials is introduced in the context of the evolution of clinical research and one chapter is devoted to the more recent Bayesian procedures. From the reviews: "The author has a wealth of experience in this area and this is demonstrated throughout the text with relevant poignant examples." Short Book Reviews of the ISI, June 2006

Fundamentals Of Clinical Psychopharmacology

Author: Ian M. Anderson
Publisher: CRC Press
ISBN: 1841844276
Size: 42.63 MB
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This book brings together leading UK psychiatrists and psychopharmacologists to review and clarify essential information about the scientific background and clinical applications of the drugs used in psychiatry. Based on the excellent Psychopharmacology Course for Psychiatrists in Training, organized twice a year by the British Association for Psychopharmacology, Fundamentals of Clinical Psychopharmacology reflects the individual lectures that make up the course, ranging from basic neuroscience to the analysis of clinical trials. The book is updated regularly, and this Second Edition includes a helpful new chapter on child and adolescent psychopharmacology.

The Fundamentals Of Clinical Data Management

Author: S. Fernandez
Publisher: CreateSpace
ISBN: 9781516986576
Size: 48.91 MB
Format: PDF, Docs
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"The Fundamentals of Clinical Data Management" is a manual for Sponsors, CROs, Investigators, Clinical Trial Monitors and Managers and Clinical Research Professionals to learn the basic concepts of Clinical Data Management. This book will focus on the topic which includes: Clinical Information Flow, Roles and Responsibilities of CDM Personnel, Guidelines Associated with CDM, Data Management Plan, CRF Designing, Data Collection, Cleaning and Data Validation, Study setup and Database Designing, Laboratory Data and Adverse Event Data Management, Report Creation and Data Closure, Data Archiving, Privacy and Security etc.

Clinical Trial Design

Author: Guosheng Yin
Publisher: John Wiley & Sons
ISBN: 1118183320
Size: 45.86 MB
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A balanced treatment of the theories, methodologies, and designissues involved in clinical trials using statisticalmethods There has been enormous interest and development in Bayesianadaptive designs, especially for early phases of clinical trials.However, for phase III trials, frequentist methods still play adominant role through controlling type I and type II errors in thehypothesis testing framework. From practical perspectives, ClinicalTrial Design: Bayesian and Frequentist Adaptive Methods providescomprehensive coverage of both Bayesian and frequentist approachesto all phases of clinical trial design. Before underpinning variousadaptive methods, the book establishes an overview of thefundamentals of clinical trials as well as a comparison of Bayesianand frequentist statistics. Recognizing that clinical trial design is one of the mostimportant and useful skills in the pharmaceutical industry, thisbook provides detailed discussions on a variety of statisticaldesigns, their properties, and operating characteristics for phaseI, II, and III clinical trials as well as an introduction to phaseIV trials. Many practical issues and challenges arising in clinicaltrials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacytrade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs andstatistical methods that have been employed at the world's leadingmedical centers as well as in the pharmaceutical industry. Thesoftware used throughout the book is freely available on the book'srelated website, equipping readers with the necessary tools fordesigning clinical trials. Clinical Trial Design is an excellent book for courses on thetopic at the graduate level. The book also serves as a valuablereference for statisticians and biostatisticians in thepharmaceutical industry as well as for researchers andpractitioners who design, conduct, and monitor clinical trials intheir everyday work.

Clinical Trials

Author: Tom Brody
Publisher: Academic Press
ISBN: 0128042583
Size: 20.76 MB
Format: PDF, Kindle
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Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers