Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
Author: Evan DeRenzo,Eric A. Singer,Joel Moss
Publsiher: Academic Press
Total Pages: 370
Release: 2020-07-10
ISBN 10: 0123869358
ISBN 13: 9780123869357
Language: EN, FR, DE, ES & NL

Ethical Considerations When Preparing a Clinical Research Protocol Book Review:

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations

Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
Author: Evan DeRenzo,Eric A. Singer,Joel Moss
Publsiher: Academic Press
Total Pages: 370
Release: 2020-06-12
ISBN 10: 0123869544
ISBN 13: 9780123869548
Language: EN, FR, DE, ES & NL

Ethical Considerations When Preparing a Clinical Research Protocol Book Review:

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations

Writing Clinical Research Protocols

Writing Clinical Research Protocols
Author: Evan G. DeRenzo,Joel Moss
Publsiher: Academic Press
Total Pages: 300
Release: 2006
ISBN 10: 9780122107511
ISBN 13: 0122107519
Language: EN, FR, DE, ES & NL

Writing Clinical Research Protocols Book Review:

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publsiher: National Academies Press
Total Pages: 445
Release: 2004-07-09
ISBN 10: 9780309133388
ISBN 13: 0309133386
Language: EN, FR, DE, ES & NL

Ethical Conduct of Clinical Research Involving Children Book Review:

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
Author: John I. Gallin,Frederick P Ognibene
Publsiher: Elsevier
Total Pages: 448
Release: 2011-04-28
ISBN 10: 9780080489568
ISBN 13: 0080489567
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Research Book Review:

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

Principles of Good Clinical Practice

Principles of Good Clinical Practice
Author: Michael J. McGraw,Shawn P. Shearn
Publsiher: Pharmaceutical Press
Total Pages: 256
Release: 2010
ISBN 10: 0853697906
ISBN 13: 9780853697909
Language: EN, FR, DE, ES & NL

Principles of Good Clinical Practice Book Review:

This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and dependent ethics committees; clinical trial registration and reporting; quality assurance; and future implications for good clinical practices. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries

Integrating Clinical Research into Epidemic Response

Integrating Clinical Research into Epidemic Response
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Global Health,Committee on Clinical Trials During the 2014-2015 Ebola Outbreak
Publsiher: National Academies Press
Total Pages: 342
Release: 2017-07-26
ISBN 10: 0309457769
ISBN 13: 9780309457767
Language: EN, FR, DE, ES & NL

Integrating Clinical Research into Epidemic Response Book Review:

The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

Reviewing Clinical Trials

Reviewing Clinical Trials
Author: Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc
Publsiher: Unknown
Total Pages: 153
Release: 2010
ISBN 10: 9789881904119
ISBN 13: 9881904110
Language: EN, FR, DE, ES & NL

Reviewing Clinical Trials Book Review:

The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.

Research Ethics in Africa

Research Ethics in Africa
Author: Mariana Kruger,Paul Ndebele,Lyn Horn
Publsiher: AFRICAN SUN MeDIA
Total Pages: 224
Release: 2014-06-01
ISBN 10: 1920689303
ISBN 13: 9781920689308
Language: EN, FR, DE, ES & NL

Research Ethics in Africa Book Review:

The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The authors are currently active in various aspects of research ethics in Africa and the majority have been trained in the past by either the Fogarty International Center or Europe and Developing Countries Clinical Trial Partnership (EDCTP) sponsored bioethics training programmes .

Clinical Trials in Vulnerable Populations

Clinical Trials in Vulnerable Populations
Author: Milica Prostran
Publsiher: BoD – Books on Demand
Total Pages: 224
Release: 2018-05-09
ISBN 10: 1789232007
ISBN 13: 9781789232004
Language: EN, FR, DE, ES & NL

Clinical Trials in Vulnerable Populations Book Review:

This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.

Field Trials of Health Interventions

Field Trials of Health Interventions
Author: Richard H. Morrow,David A. Ross
Publsiher: Oxford University Press, USA
Total Pages: 480
Release: 2015-06-11
ISBN 10: 0198732864
ISBN 13: 9780198732860
Language: EN, FR, DE, ES & NL

Field Trials of Health Interventions Book Review:

Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in "field trials", which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial design and conduct are discussed fully and in sufficient detail for the text to be used as a "toolbox" by field investigators. The toolbox has now been extensively tested through use of the first two editions and this third edition is a comprehensive revision, incorporating the many developments that have taken place with respect to trials since 1996 and involving more than 30 contributors. Most of the chapters have been extensively revised and 7 new chapters have been added.

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Publsiher: National Academies Press
Total Pages: 432
Release: 2012-10-13
ISBN 10: 0309225493
ISBN 13: 9780309225496
Language: EN, FR, DE, ES & NL

Safe and Effective Medicines for Children Book Review:

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

The Management of Clinical Trials

The Management of Clinical Trials
Author: Hesham Abdeldayem
Publsiher: BoD – Books on Demand
Total Pages: 90
Release: 2018-06-06
ISBN 10: 1789232384
ISBN 13: 9781789232387
Language: EN, FR, DE, ES & NL

The Management of Clinical Trials Book Review:

This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.

Children and Clinical Research

Children and Clinical Research
Author: Anonim
Publsiher: Unknown
Total Pages: 221
Release: 2015
ISBN 10: 9781904384311
ISBN 13: 1904384315
Language: EN, FR, DE, ES & NL

Children and Clinical Research Book Review:

The Oxford Textbook of Clinical Research Ethics

The Oxford Textbook of Clinical Research Ethics
Author: Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller,David D. Wendler
Publsiher: OUP USA
Total Pages: 848
Release: 2011-02
ISBN 10: 0199768633
ISBN 13: 9780199768639
Language: EN, FR, DE, ES & NL

The Oxford Textbook of Clinical Research Ethics Book Review:

The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

The National Bioethics Advisory Commission

The National Bioethics Advisory Commission
Author: Elisa Eiseman
Publsiher: Rand Corporation
Total Pages: 172
Release: 2003
ISBN 10: 9780833033642
ISBN 13: 0833033646
Language: EN, FR, DE, ES & NL

The National Bioethics Advisory Commission Book Review:

The National Bioethics Advisory Commission (NBAC) was established in 1995 to advise various government entities on issues arising from research on human biology and behavior. During its five-year tenure, NBAC submitted six reports to the White House containing 120 recommendations on several complex bioethical issues including the cloning of human beings and embryonic stem cell research. This study assesses NBAC's contribution to policymaking by tracking the response to NBAC's recommendations from the president, Congress, government, societies and foundations, other countries, and international groups.

Current Topics in Public Health

Current Topics in Public Health
Author: Alfonso J. Rodriguez-Morales
Publsiher: BoD – Books on Demand
Total Pages: 744
Release: 2013-05-15
ISBN 10: 9535111213
ISBN 13: 9789535111214
Language: EN, FR, DE, ES & NL

Current Topics in Public Health Book Review:

Public Health is regarded as the basis and cornerstone of health, generally and in medicine. Defined as the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals, this discipline has been renewed by the incorporation of multiple actors, professions, knowledge areas and it has also been impacted and promoted by multiple technologies, particularly - the information technology. As a changing field of knowledge, Public Health requires evidence-based information and regular updates. Current Topics in Public Health presents updated information on multiple topics related to actual areas of interest in this growing and exciting medical science, with the conception and philosophy that we are working to improve the health of the population, rather than treating diseases of individual patients, taking decisions about collective health care that are based on the best available, current, valid and relevant evidence, and finally within the context of available resources. With participation of authors from multiple countries, many from developed and developing ones, this book offers a wide geographical perspective. Finally, all these characteristics make this book an excellent update on many subjects of world public health.

Handbook for Good Clinical Research Practice GCP

Handbook for Good Clinical Research Practice  GCP
Author: World Health Organization
Publsiher: Unknown
Total Pages: 125
Release: 2005
ISBN 10: 9789241593922
ISBN 13: 924159392X
Language: EN, FR, DE, ES & NL

Handbook for Good Clinical Research Practice GCP Book Review:

Schizophrenia Bulletin

Schizophrenia Bulletin
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2006
ISBN 10:
ISBN 13: STANFORD:36105132173860
Language: EN, FR, DE, ES & NL

Schizophrenia Bulletin Book Review:

Casebook on Ethical Issues in International Health Research

Casebook on Ethical Issues in International Health Research
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 209
Release: 2009
ISBN 10: 9241547723
ISBN 13: 9789241547727
Language: EN, FR, DE, ES & NL

Casebook on Ethical Issues in International Health Research Book Review:

I. Defining "research"--II. Issues in study design . -- III. Harm and benefit -- IV. Voluntary informed consent -- V. Standard of care -- VI. Obligations to participants and communities -- VII. Privacy and confidentiality -- VIII. Professional ethics.