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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: 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: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309268745
Category : Medical
Languages : en
Pages : 157
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Book Description
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.
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: Fay A. Rozovsky
Publisher: Jossey-Bass
ISBN: 9780787965709
Category : Medical
Languages : en
Pages : 0
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Book Description
This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
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: 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: 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: SK Gupta
Publisher: JP Medical Ltd
ISBN: 9350252724
Category : Medical
Languages : en
Pages : 659
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Book Description
The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multi-faceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry. To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird’s eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry’s growth.
Author: James Mittra
Publisher: CRC Press
ISBN: 9814364843
Category : Mathematics
Languages : en
Pages : 290
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Book Description
This book brings together a range of academic, industry and practitioner perspectives on translational medicine (TM). It enhances conceptual and practical understanding of the emergence and progress of the field and its potential impact on basic research, therapeutic development, and institutional infrastructure. In recognition of the various impli
