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Author: Edward H. Ahrens
Publisher: Oxford University Press, USA
ISBN: 9780195051568
Category : Medical
Languages : en
Pages : 270
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Book Description
The current crisis in clinical research cannot be fully appreciated unless the underlying economic, sociological and motivational problems in American medicine are fully understood. Accordingly, this important book describes the evolution of biomedical research in relation to changes in institutional perceptions of the importance of each of the three roles that U.S. medical schools play--teaching, research and service to patients. Ahrens meticulously analyzes seven very different kinds of research activity that are included under the term "clinical research." He describes the profound shift in emphasis from patient-oriented research to research at the cellular and molecular level. This shift has created an imbalance between two contrasting research approaches to the problems of human disease--reductionism and integrative research. In searching out the reasons for this change, Ahrens carefully examines institutional supports for clinical research--the medical school environment in which the research is carried out and the main funding source, the National Institutes of Health. This timely work identifies the fundamental differences between reductionism and integrative research and provides clear evidence that if both modes are to prosper in the future, as they must, then patient-oriented research must receive far stronger support from U.S. medical schools and the N.I.H. Ahrens masterfully argues that changes must be made in the special training of clinical investigators and in their funding requirements, and that new working partnerships between clinically skilled M.D.s and technically trained Ph.D.s are urgently needed in order to restore patient-oriented research to full productivity and to accomplish a re-balancing that most effectively assures quality research in the future.
Author: Jon Jureidini
Publisher:
ISBN: 9781743057247
Category :
Languages : en
Pages : 330
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Book Description
An exposé of the corruption of medicine by the pharmaceutical industry at every level, from exploiting the vulnerable destitute for drug testing, through manipulation of research data, to disease mongering and promoting drugs that do more harm than good. Authors, Professor Jon Jureidini and Dr Leemon McHenry, made critical contributions to exposing the scientific misconduct in two infamous trials of antidepressants. Ghostwritten publications of these trials were highly influential in prescriptions of paroxetine (Paxil) and citalopram (Celexa) in paediatric and adolescent depression, yet both trials (Glaxo Smith Kline's paroxetine study 329 and Forest Laboratories' citalopram study CIT-MD-18) seriously misrepresented the efficacy and safety data. The Illusion of Evidence-Based Medicine provides a detailed account of these studies and argues that medicine desperately needs to re-evaluate its relationship with the pharmaceutical industry. Without a basis for independent evaluation of the results of randomised, placebo-controlled clinical trials, there can be no confidence in evidence-based medicine. Science demands rigorous, critical examination and especially severe testing of hypotheses to function properly, but this is exactly what is lacking in academic medicine.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309253187
Category : Medical
Languages : en
Pages : 248
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Book Description
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Author: Edward H. Ahrens
Publisher: Oxford University Press, USA
ISBN: 9780195051568
Category : Medical
Languages : en
Pages : 270
Get Book Here
Book Description
The current crisis in clinical research cannot be fully appreciated unless the underlying economic, sociological and motivational problems in American medicine are fully understood. Accordingly, this important book describes the evolution of biomedical research in relation to changes in institutional perceptions of the importance of each of the three roles that U.S. medical schools play--teaching, research and service to patients. Ahrens meticulously analyzes seven very different kinds of research activity that are included under the term "clinical research." He describes the profound shift in emphasis from patient-oriented research to research at the cellular and molecular level. This shift has created an imbalance between two contrasting research approaches to the problems of human disease--reductionism and integrative research. In searching out the reasons for this change, Ahrens carefully examines institutional supports for clinical research--the medical school environment in which the research is carried out and the main funding source, the National Institutes of Health. This timely work identifies the fundamental differences between reductionism and integrative research and provides clear evidence that if both modes are to prosper in the future, as they must, then patient-oriented research must receive far stronger support from U.S. medical schools and the N.I.H. Ahrens masterfully argues that changes must be made in the special training of clinical investigators and in their funding requirements, and that new working partnerships between clinically skilled M.D.s and technically trained Ph.D.s are urgently needed in order to restore patient-oriented research to full productivity and to accomplish a re-balancing that most effectively assures quality research in the future.
Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 70
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Book Description
Author: Lydia Woods Schindler
Publisher: DIANE Publishing
ISBN: 0788148826
Category :
Languages : en
Pages : 62
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Book Description
Presents the proceedings of a hearing on how much & how best to maximize the return of Federal investment in medical research. Includes testimony by representatives from the National Institutes of Health, Oregon Health Sciences Univ., Emory Univ., Brigham & Women's Hospital, Oregon Biotechnology Assoc., Amer. Fed. of Clinical Research, & PI Medical, Inc. Also includes discussions on loan repayment programs, collaboration with other agencies, governmentwide clinical research, clinical research panels, first awards, & the lack of young, trained clinical researchers.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470466359
Category : Science
Languages : en
Pages : 1247
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Book Description
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Author: United States. Congress. Senate. Committee on Labor and Human Resources
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 96
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Book Description
Author: Felipe Fregni
Publisher: Oxford University Press
ISBN: 0199324492
Category : Medical
Languages : en
Pages : 537
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Book Description
Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.
Author: Stanley P. L. Leong
Publisher: Springer Science & Business Media
ISBN: 0387332251
Category : Medical
Languages : en
Pages : 326
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Book Description
Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application. The book has a foreword by Samuel A. Wells, Jr., MD, Professor of Surgery, Duke University Medical Center, Durham, NC, former Director of the American College of Surgeons and Founder of the American College of Surgeons Oncology Group.
