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| clinical research studies for money: Ethical Conduct of Clinical Research Involving Children Institute of Medicine, Board on Health Sciences Policy, Committee on Clinical Research Involving Children, 2004-07-09 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. |
| clinical research studies for money: Transforming Clinical Research in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2010-10-22 An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise. |
| clinical research studies for money: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 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. |
| clinical research studies for money: Neuroscience Trials of the Future National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2016-11-07 On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future. |
| clinical research studies for money: Beyond the HIPAA Privacy Rule Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, 2009-03-24 In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research. |
| clinical research studies for money: The Role of Purchasers and Payers in the Clinical Research Enterprise Institute of Medicine, Board on Health Sciences Policy, Clinical Research Roundtable, 2002-06-14 In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective. |
| clinical research studies for money: Designing Clinical Research Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman, 2011-11-30 Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly. |
| clinical research studies for money: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors. |
| clinical research studies for money: Sharing Clinical Research Data Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Roundtable on Translating Genomic-Based Research for Health, National Cancer Policy Forum, Forum on Neuroscience and Nervous System Disorders, Forum on Drug Discovery, Development, and Translation, 2013-06-07 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. |
| clinical research studies for money: Virtual Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-11-16 Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop. |
| clinical research studies for money: Small Clinical Trials Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Small-Number-Participant Clinical Research Trials, 2001-01-01 Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a large trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement. |
| clinical research studies for money: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-09-13 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. |
| clinical research studies for money: Testing Treatments Imogen Evans, Hazel Thornton, Iain Chalmers, Paul Glasziou, 2011 This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies. |
| clinical research studies for money: A National Cancer Clinical Trials System for the 21st Century Institute of Medicine, Board on Health Care Services, Committee on Cancer Clinical Trials and the NCI Cooperative Group Program, 2010-07-08 The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research. |
| clinical research studies for money: Economic Evaluation in Clinical Trials Henry A. Glick, Jalpa A. Doshi, Seema S. Sonnad, 2014-10-02 It is increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. This book provides a practical guide to the techniques and issues involved in conducting economic evaluation in ongoing clinical trials, supported with examples. |
| clinical research studies for money: Trial by Fire Allan Gaw, 2009 |
| clinical research studies for money: A Concise Guide to Clinical Trials Allan Hackshaw, 2011-09-07 Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies |
| clinical research studies for money: Cancer Clinical Trials Tomasz M. Beer, Larry Axmaker, 2012 A readable guide for anyone who is considering therapeutic options in addition to standard cancer therapy. The book seeks to share knowledge about cancer clinical trials with people living with cancer, their families and loved ones. |
| clinical research studies for money: The Professional Guinea Pig Roberto Abadie, 2010-07-30 The Professional Guinea Pig documents the emergence of the professional research subject in Phase I clinical trials testing the safety of drugs in development. Until the mid-1970s Phase I trials were conducted on prisoners. After that practice was outlawed, the pharmaceutical industry needed a replacement population and began to aggressively recruit healthy, paid subjects, some of whom came to depend on the income, earning their living by continuously taking part in these trials. Drawing on ethnographic research among self-identified “professional guinea pigs” in Philadelphia, Roberto Abadie examines their experiences and views on the conduct of the trials and the risks they assume by participating. Some of the research subjects he met had taken part in more than eighty Phase I trials. While the professional guinea pigs tended to believe that most clinical trials pose only a moderate health risk, Abadie contends that the hazards presented by continuous participation, such as exposure to potentially dangerous drug interactions, are discounted or ignored by research subjects in need of money. The risks to professional guinea pigs are also disregarded by the pharmaceutical industry, which has become dependent on the routine participation of experienced research subjects. Arguing that financial incentives compromise the ethical imperative for informed consent to be freely given by clinical-trials subjects, Abadie confirms the need to reform policies regulating the participation of paid subjects in Phase I clinical trials. |
| clinical research studies for money: When Experiments Travel Adriana Petryna, 2009-04-27 The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives. |
| clinical research studies for money: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps |
| clinical research studies for money: Code of Human Research Ethics , 2014 |
| clinical research studies for money: Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine, Board on Health Sciences Policy, Committee on Conflict of Interest in Medical Research, Education, and Practice, 2009-09-16 Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine. |
| clinical research studies for money: The Oxford Textbook of Clinical Research Ethics Ezekiel J. Emanuel, Christine C. Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David D. Wendler, 2011-02 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. |
| clinical research studies for money: Understanding Clinical Papers David Bowers, Allan House, David Owens, 2006-05-01 Now in its Second Edition, this book helps to unravel the processof evidence-based practice, which requires clinicians to evaluateand collate information from the journals they read.Understanding Clinical Papers, SecondEdition uses actual papers to illustrate how tounderstand and evaluate published research, but goes beyond this toprovide an explanation of a range of important research-relatedtopics. Understanding Clinical Papers, Second Edition: Covers everything necessary to understand a clinical researchpaper Examples are illustrated and based uniquely on tables,abstracts and exerts from published clinical research papers Amazingly clear, lively, accessible style The new edition has been markedly improved and extended,containing, for example, new material on measurement scales,systematic reviews, writing a paper, statistics software andcritical appraisal “What strikes the reader... straight away isclarity… promises to become a recommended text forundergraduate and postgraduate courses. JOURNAL OF TROPICALPEDIATRICS “The writing style is amazingly clear and does notrequire formal course work in biostatistics orepidemiology…We strongly recommend it for beginners and foreasy entry into a complex domain and to experts who we think willenjoy it and who will find it useful as they teach, advise and helpothers.” QUALITY IN HEALTH CARE “What makes this book unique is that each pointpresented is illustrated with excerpts from actual papers, oftenthree or four per chapter... this is a very effective teachingdevice. JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION “This book should be an essential addition to thepersonal libraries of all health care workers who need to usearticles in journals. In these days of evidence-based medicine,this should apply to all physicians, nurses and other healthprofessionals.” ONCOLOGY Understanding Clinical Papers, Second Edition isan invaluable resource for everyone involved directly or indirectlyin health care – an ultimate guide for those who readclinical literature. |
| clinical research studies for money: Understanding Clinical Research Renato D. Lopes, Robert A. Harrington, 2013-05-22 A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials |
| clinical research studies for money: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. |
| clinical research studies for money: Medical Nihilism Jacob Stegenga, 2018 Medical nihilism is the view that we should have little confidence in the effectiveness of medical interventions. Jacob Stegenga argues persuasively that this is how we should see modern medicine, and suggests that medical research must be modified, clinical practice should be less aggressive, and regulatory standards should be enhanced. |
| clinical research studies for money: Clinical Practice Guidelines We Can Trust Institute of Medicine, Board on Health Care Services, Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, 2011-06-16 Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers. |
| clinical research studies for money: Medical Research for Hire Jill A. Fisher, 2009 Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians. According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer free doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care. A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden |
| clinical research studies for money: Political and Economic Implications of Blockchain Technology in Business and Healthcare Rodrigues, Dário de Oliveira, 2021-06-11 Besides love, money and health are the most valuable human yearnings. Therefore, blockchain technology is paramount: a new foundation of confidence for human valuable transactions. Like information sharing was catalyzed on the pre-blockchain internet, transactions are now triggered on the new internet of value. In this second digital inflection point, economic media encompasses value beside information, and individuals can privately transact digital assets for the first time in history. Decentralized but structured organizations running on blockchain networks reduce transaction costs and are particularly competitive insofar as they guarantee data authenticity, confidentiality, and integrity, providing functional autonomy with disintermediation and smart contracts. Everything changed after user data were made public on the internet and privately traded by big tech companies, and nothing will be the same once that data is made private on the internet and publicly transacted by their rightful owners. While the internet of information reshaped the world, the internet of value will reform it, and everything will depend politically on this being done freely. Political and Economic Implications of Blockchain Technology in Business and Healthcare provides relevant theoretical frameworks on the civilizational impact of blockchain technology, which redesigns human interactions concerning value transactions. It gives ideas, concepts, and instruments to advance the knowledge on cryptoeconomics and decentralized governance in the new distributed trust paradigm. The chapters explore the ethical repercussions and profound political-economic consequences to society, providing insights into business applications focusing on the healthcare sector. In a blockchain era affected by the post-COVID-19 new normal, which mixes politics, economics, and health, this book is essential for students and researchers in social and life sciences; professionals and policymakers working in the fields of public and business administration; and healthcare workers and researchers, academicians, and students interested in blockchain technology and its political and economic impacts in the industry and society. |
| clinical research studies for money: Oxford Textbook of Palliative Social Work Terry Altilio MSW, ACSW, LCSW, Shirley Otis-Green MSW, ACSW, LCSW, OSW, 2011-03-23 The Oxford Textbook of Palliative Social Work is a comprehensive, evidence-informed text that addresses the needs of professionals who provide interdisciplinary, culturally sensitive, biopsychosocial-spiritual care for patients and families living with life-threatening illness. Social workers from diverse settings will benefit from its international scope and wealth of patient and family narratives. Unique to this scholarly text is its emphasis on the collaborative nature inherent in palliative care. This definitive resource is edited by two leading palliative social work pioneers who bring together an array of international authors who provide clinicians, researchers, policy-makers, and academics with a broad range of content to enrich the guidelines recommended by the National Consensus Project for Quality Palliative Care. |
| clinical research studies for money: Implementing a National Cancer Clinical Trials System for the 21st Century Institute of Medicine, Board on Health Care Services, National Cancer Policy Forum, 2011-09-19 Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research. Thus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation. |
| clinical research studies for money: In Cold Blood Truman Capote, |
| clinical research studies for money: International Ethical Guidelines for Health-Related Research Involving Humans Council for International Organizations of Medical Sciences (CIOMS), 2017-01-31 In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.--Page 4 de la couverture. |
| clinical research studies for money: Ethics and Regulation of Clinical Research Robert J. Levine, 1988-01-01 The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone--members of institutional review boards, scientists, philosophers, lawyers--addressing the ethical issues involved. [Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions. . . [The book] is sophisticated but readable. . . [and] should be on every IRB administrator's desk and in every medical ethics library.--Norman Fost, M.D., The New England Journal of Medicine Levine. . . is one of the foremost historians of contemporary clinical science. . . . His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history.--Daniel M. Fox, Bulletin of the History of Medicine You will be charmed by the [book's] elegance and lucidity and. . . persuaded of its relevance to doctors in any country.--Alex Paton, British Medical Journal Should be of wide interest to those keen to see advances in medical research brought into general medical practice.--Gilbert Omenn, Issues in Science and Technology |
| clinical research studies for money: Medical Research for Hire Jill A. Fisher, 2008-11-06 Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians. According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer free doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care. A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden |
| clinical research studies for money: Reviewing Clinical Trials 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, 2010 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. |
| clinical research studies for money: Research Methods in Health Ann Bowling, 2002-01 This second edition has been revised and updated to reflect key methodological developments in health research. It is a comprehensive, easy to read, guide to the range of methods used to study and evaluate health and health services. It describes the concepts and methods used by the main disciplines involved in health research, including: demography, epidemiology, health economics, psychology and sociology. |
| clinical research studies for money: The Illusion of Evidence-Based Medicine Jon Jureidini, Leemon B. McHenry, 2020-05-28 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. |
Standard Costs and Fees for Sponsored Clinical Trials
Aug 4, 2023 · Clinical Research Finance Start-up Fee up to $5,980: Accounting for an average of 40 hours of research administrative effort to prepare, review, and submit the budget and contract.
Guideline for Investigators Regarding Paying Subjects for …
When deciding whether to offer payment to subjects, consider the nature of the study, the type of participant contributions and vulnerabilities, institutional or organizational guidelines, and local …
NIH Clinical Trial Budgeting
Coverage Analysis: analysis of study documentation and Medicare billing guidelines to determine what is deemed part of the clinical research study and what can be billed to insurance.
Investigator Compensation: Understanding the Basics, …
Each budget cycle, based on the number and complexity of studies–often evaluated by phase II, III, or IV–a “clinical research investigator” salary line was developed to reflect the expected …
Subject_Payment - Research Administration
Investigators often wish to and are encouraged to provide reimbursement for parking, transportation and childcare costs for research-related visits (with the possible exception of the …
Budgeting, Tracking and Invoicing for a Clinical Trial
~11% of MGH Clinical Research study funds are in deficit – some over $100,000. What is being done? Who will be doing the work? PI, CRC, RN? How long will it take? Check to see what …
Paying for Clinical Trials - Perelman School of Medicine at the ...
While some research studies will pay participants for their time and effort, cancer clinical trials do not pay people to participate. Federal law requires most insurance companies to cover “routine …
Medicare and clinical research studies.
Clinical research studies (also called clinical trials) help doctors and researchers test how well diferent types of medical care work and if they’re safe. You may have the choice to join a …
6 Must-Read Articles on Payments to Research Participants
3. “Clinical Trials Funded by... Patients?” c of charging patients to participate in clinical trials. With millions of dollars spent on the average protocol, clinical trials are by the far t e most …
memorandum - Internal Revenue Service
Some fees may be subject to SECA tax because the participants are in a trade or business of participating in medical research studies. It is unlikely that a majority of these fees are incurred …
A Guide to Costs and Payments in Clinical Trials - CISCRP
Questions to ask If you are thinking about joining a clinical trial, make sure you find out all you can about the costs and payment or reimbursement options. Questions to ask the trial staff: What …
Finder's Fees and Payments to Research and Clinical Staff
Apr 1, 2014 · Clinicians may be paid a reasonable amount for any services (e.g., obtaining a medical history, performing screening examinations, conducting medical record reviews) they …
Fundamentals of Clinical Trial Financial Management
It tells a story of study/project performance based on the revenue earned and expenses (costs) incurred at a point in time. Provides a snapshot of the financial status of a study/project. …
PAYMENTS AND INCENTIVES IN RESEARCH - University of …
The purpose of this guidance is to highlight the ethical issues raised by the provision of different forms of payments to research participants, and to suggest points to consider when planning …
Clinical Studies on the Cheap
Challenges faced by traditional clinical studies Money, money, money Funding begat funding: what happens to the little guy who has a dream Studies begat studies: where are my prelims …
Payments in Human Research Subjects: Guidance and …
The main ethical concern with remunerating subjects for participation in clinical research is that payment has the potential to constitute undue inducement, distorting the judgment of subjects …
Paying Clinical Trial Participants: Legal Risks and Mitigation …
Here, we identify legal considerations relevant to participant remuneration stemming from federal and state anti-kickback stat-utes, anti-fraud elements of the Health Insurance Portability and …
COMPENSATION OF RESEARCH SUBJECTS
When hourly payments are not suitable or feasible, compensation may be task- or procedure-specific (for example, some studies pay subjects per sample collection or survey). In general, …
Clinical Research Studies For Money (2024)
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials,2001-01-01 Clinical trials are used to elucidate the most …
A Guide to Costs and Payments in Clinical Trials - CISCRP
Questions to ask your health insurance provider: What costs will you cover if I participate in a clinical trial? ou cover routine care that the trial Is care at my trial site in-network? If I have …
Standard Costs and Fees for Sponsored Clinical Trials
Aug 4, 2023 · Clinical Research Finance Start-up Fee up to $5,980: Accounting for an average of 40 hours of research administrative effort to prepare, review, and submit the budget and contract.
Guideline for Investigators Regarding Paying Subjects for …
When deciding whether to offer payment to subjects, consider the nature of the study, the type of participant contributions and vulnerabilities, institutional or organizational guidelines, and local …
NIH Clinical Trial Budgeting
Coverage Analysis: analysis of study documentation and Medicare billing guidelines to determine what is deemed part of the clinical research study and what can be billed to insurance.
Investigator Compensation: Understanding the Basics, …
Each budget cycle, based on the number and complexity of studies–often evaluated by phase II, III, or IV–a “clinical research investigator” salary line was developed to reflect the expected …
Subject_Payment - Research Administration
Investigators often wish to and are encouraged to provide reimbursement for parking, transportation and childcare costs for research-related visits (with the possible exception of the …
Budgeting, Tracking and Invoicing for a Clinical Trial
~11% of MGH Clinical Research study funds are in deficit – some over $100,000. What is being done? Who will be doing the work? PI, CRC, RN? How long will it take? Check to see what …
Paying for Clinical Trials - Perelman School of Medicine at the ...
While some research studies will pay participants for their time and effort, cancer clinical trials do not pay people to participate. Federal law requires most insurance companies to cover “routine …
Medicare and clinical research studies.
Clinical research studies (also called clinical trials) help doctors and researchers test how well diferent types of medical care work and if they’re safe. You may have the choice to join a …
6 Must-Read Articles on Payments to Research Participants
3. “Clinical Trials Funded by... Patients?” c of charging patients to participate in clinical trials. With millions of dollars spent on the average protocol, clinical trials are by the far t e most …
memorandum - Internal Revenue Service
Some fees may be subject to SECA tax because the participants are in a trade or business of participating in medical research studies. It is unlikely that a majority of these fees are incurred …
A Guide to Costs and Payments in Clinical Trials - CISCRP
Questions to ask If you are thinking about joining a clinical trial, make sure you find out all you can about the costs and payment or reimbursement options. Questions to ask the trial staff: What …
Finder's Fees and Payments to Research and Clinical Staff
Apr 1, 2014 · Clinicians may be paid a reasonable amount for any services (e.g., obtaining a medical history, performing screening examinations, conducting medical record reviews) they …
Fundamentals of Clinical Trial Financial Management
It tells a story of study/project performance based on the revenue earned and expenses (costs) incurred at a point in time. Provides a snapshot of the financial status of a study/project. …
PAYMENTS AND INCENTIVES IN RESEARCH - University of …
The purpose of this guidance is to highlight the ethical issues raised by the provision of different forms of payments to research participants, and to suggest points to consider when planning …
Clinical Studies on the Cheap
Challenges faced by traditional clinical studies Money, money, money Funding begat funding: what happens to the little guy who has a dream Studies begat studies: where are my prelims …
Payments in Human Research Subjects: Guidance and …
The main ethical concern with remunerating subjects for participation in clinical research is that payment has the potential to constitute undue inducement, distorting the judgment of subjects …
Paying Clinical Trial Participants: Legal Risks and …
Here, we identify legal considerations relevant to participant remuneration stemming from federal and state anti-kickback stat-utes, anti-fraud elements of the Health Insurance Portability and …
COMPENSATION OF RESEARCH SUBJECTS
When hourly payments are not suitable or feasible, compensation may be task- or procedure-specific (for example, some studies pay subjects per sample collection or survey). In general, …
Clinical Research Studies For Money (2024)
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials,2001-01-01 Clinical trials are used to elucidate the most …
