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Learn rigorous statistical methods to ensure valid clinical trialsThis Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of

Pharmacology. Therapy --- Biomedical Research --- Clinical Trials --- Clinical trials --- Research --- Statistics --- methods. --- Statistical methods. --- Research Design --- Clinical Trials as Topic --- Statistics as Topic --- Statistical methods --- methods

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This book describes an innovative approach to the evaluation of complex health interventions, assessing what interventions work, how and for whom. Rejecting the stalemate between trials and realist evaluation, it draws on the best of both. Randomised controlled trials and systematic reviews offer the least biased means of assessing intervention effects but tell us little scientifically about how interventions work. Policy-makers and practitioners are also not supported to decide which interventions are likely to achieve most benefits in their local contexts. Realists use other forms of evaluation and evidence synthesis exploring how intervention mechanisms interact with context to generate outcomes. But these approaches lack rigour in assessing causality. This book proposes how realist evaluation methods may be incorporated within randomised controlled trials and systematic reviews. This enables evaluations and evidence synthesis to benefit from the more nuanced questions posed within realist enquiry while maintaining rigour in assessing causality.

Health Policy. --- Therapies, Investigational --- Clinical Trials as Topic. --- Systematic Reviews as Topic. --- Evidence-Based Medicine. --- methods. --- Medical policy. --- Evidence-based medicine.

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Clinical Trials and Tribulations evaluates the multiple layers of complexities around research management, also exploring current practices, challenges and future directions. The book provides answers to readers questions and problems through extensive use of real-world examples, case studies and lessons learned. Following an approach to provide pragmatic viewpoints as well as concepts and methodologies and its alignment with specific practices, the book explores paradigms between planning and conducting research in academia vs. healthcare vs. industry in the UK vs. Europe vs. America. It highlights practical solutions to real-world complex issues that have been documented by independent regulators. This will be an indispensable book for all staff working in clinical research within healthcare, academia and industry, as well as students intending to work in clinical trials. Covers key topics across pre-clinical, clinical research and clinical practice. Highlights areas such as the socioeconomics of conducting research, capacity and capability, research quality and performance (including performance indicators, adaptive design and practical solutions); Provides lessons learned from breach of protocols, ethical breaches, SAE/SUSARs, aseptic pharmacy preparation issues, and instability within research structures ; Includes a focus on the UK clinical research system, offering key insights into working within the UK and collaborating with UK partners.

Clinical trials. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Research --- Clinical Trials as Topic --- Research Design --- Management.

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Business and medicine - United States. --- Clinical trials --- Drug development --- Drugs --- Pharmaceutical industry --- Business and medicine --- Evaluation Studies as Topic. --- Clinical Trials as Topic --- Randomized Controlled Trials as Topic --- Medicine --- Health & Biological Sciences --- Medical Research --- Economic aspects --- Social aspects --- Testing --- Clinical medicine --- Research --- Disaster medicine --- Emergency medical services --- Emergency medicine --- Standards --- Medicine, Clinical

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Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented. This book should be useful to anyone serving on a data and safety monitoring board, or planning to do so, for colleagues in academia, industry and governmental agencies, and for teaching students in biostatistics, epidemiology, clinical trials and medical ethics. No other text has as extensive a collection of cases which provide insight into the many issues, often conflicting, that must be examined before recommendations to continue or discontinue a trial can be made. While depth in statistical methods is not required, some familiarity with statistical design and analysis issues in clinical trials is helpful. The cases cover trials which were terminated early for convincing evidence of benefit, or for harmful effects. Cases with complex issues are also included. This series of cases should provide broad background information for potential monitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible. The three editors have contributed two overview chapters as well as several case studies to go along with cases contributed by a distinguished group of colleagues experienced in the design, monitoring and analysis of clinical trials. Dr. David DeMets is currently Professor and Chair, Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison. He is past president of the Eastern North American Region (ENAR) of the International Biometric Society, a past member of the Board of Directors of the American Statistical Association and an elected Fellow. He recently received the Robert Gordon Lectureship Award, given by the National Institutes of Health, for significant contributions to the field of clinical trials. Dr. Curt Furberg, is currently Professor (and former Chair) of the Department of Public Health Sciences at Wake Forest University. Previously, he was Head of the Clinical Trials Branch and Associate Director of the Clinical Applications and Prevention Program at the National Heart, Lung, and Blood Institute. Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications and a former Assistant Director for Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three are past presidents of the Society of Clinical Trials. The editors have collaborated previously as coauthors of a text: the Fundamentals of Clinical Trials.

Biomathematics. Biometry. Biostatistics --- medische statistiek --- biostatistiek --- Clinical Trials --- Automatic Data Processing. --- Clinical trials --- Etudes cliniques --- Case Reports. --- Data processing. --- Case studies. --- Informatique --- Cas, Etudes de --- Clinical trials - Data processing. --- Controlled Clinical Trials as Topic --- Research --- Professional Staff Committees --- Clinical Trials as Topic --- Quality Assurance, Health Care --- Science --- Natural Science Disciplines --- Health Care Quality, Access, and Evaluation --- Epidemiologic Study Characteristics as Topic --- Evaluation Studies as Topic --- Health Care --- Epidemiologic Methods --- Disciplines and Occupations --- Health Care Evaluation Mechanisms --- Investigative Techniques --- Quality of Health Care --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Public Health --- Environment and Public Health --- Randomized Controlled Trials as Topic --- Biomedical Research --- Clinical Trials Data Monitoring Committees --- Mathematics --- Medicine --- Physical Sciences & Mathematics --- Health & Biological Sciences --- Mathematical Statistics --- Medical Research --- Data processing --- Statistics. --- Statistics for Life Sciences, Medicine, Health Sciences. --- Statistical analysis --- Statistical data --- Statistical methods --- Statistical science --- Econometrics --- Statistics .