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| clinical research case study examples: Clinical Research John G. Brock-Utne, 2015-07-21 This book provides insights into how to be a productive clinical researcher via real-life case examples of successful clinical research -- and also clinical research gone awry. Through these examples of success and failure, the book develops a blueprint for building a career in clinical research. Future medical practice depends on the quality of the clinical trials to which drugs, devices, and treatment procedures are subjected today. However, clinical trials are not easy to do, and many physicians and health care providers who attempt clinical research struggle in this endeavor, primarily because of lack of instruction. Clinical Research aims to fill the gap between training and research through case studies of a long-time clinical researcher’s rich and varied experiences. |
| clinical research case study examples: Stakeholder Engagement: Clinical Research Cases R. Edward Freeman, Johanna Kujala, Sybille Sachs, 2017-09-18 This book offers a case-study approach to stakeholder theory that moves beyond theoretical analysis to the applied. As stakeholder theory has moved into the mainstream of management thinking in business ethics and a number of the management disciplines, there is an increasing need to explore the subtleties of stakeholder engagement via examples from practice. The case studies in this volume explore a number of aspects of the idea of stakeholder engagement, via the method of clinical case studies. Edited by leading scholars in the field of business ethics and stakeholder theory, this text affords a solid grounding in theory, brought to new levels of applied understanding of stakeholder engagement. |
| clinical research case study examples: Case Studies in Innovative Clinical Trials Kristine Broglio, Binbing Yu, 2023-11-27 Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design. Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies. Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered. A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own. |
| clinical research case study examples: Critical Thinking in Clinical Research Felipe Fregni, Ben M. W. Illigens, 2018 Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties. |
| clinical research case study examples: Clinical Evaluation of Medical Devices Karen M. Becker, John J. Whyte, 2007-11-05 The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs. |
| clinical research case study examples: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Institute of Medicine, Food and Nutrition Board, Board on Health Sciences Policy, Board on Health Care Services, Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, 2010-06-25 Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process. |
| clinical research case study examples: Case Studies in Rehabilitation Patricia A. Ghikas, Michele Clopper, 2001 Case Studies in Rehabilitation is a series of case studies compiled into one reference text for the student. This necessary textbook will allow the reader to analyze real-life examples of individuals with a variety of diagnoses and to develop clinical reasoning skills. A variety of cases are presented in Case Studies in Rehabilitation covering myriad topics such as orthopedics, neurology, rheumatology, and oncology. These case studies represent the primary adult pathologies, impairments, and functional limitations seen by clinicians. The case studies will also allow the reader to focus on the concept of disability for an individual when developing a comprehensive plan of care. The user-friendly format allows the user to choose from one of the many topics for practice in developing treatment plans, case analysis or to focus on one area of practice. An important function of this book is that it allows for the integration of didactic learning and hands-on practice when patients are not readily available. All case studies are presented in a narrative format with accompanying forms that are frequently encountered in clinical practice. Case Studies in Rehabilitation will also help students as they learn to interact with the patients they will be treating in their future careers. This text will allow them to fine-tune their skills in dealing with a variety of different patients and cases and indicate how to handle each individual case in the best possible matter. |
| clinical research case study examples: 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 case study examples: The Prevention and Treatment of Missing Data in Clinical Trials National Research Council, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, Panel on Handling Missing Data in Clinical Trials, 2010-12-21 Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. |
| clinical research case study examples: Clinical Pharmacology: Current Topics and Case Studies Markus Müller, 2011-02-04 Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP. |
| clinical research case study examples: Writing a Biomedical Research Paper Brian Budgell, 2008-12-05 All of us in biomedicine understand the urgency of getting experimental results into print as quickly as possible. Yet this critical step in the cascade from research conception to publication receives almost no attention in our formal training. It is as if we have been put to sea without a compass. Our collective failure to achieve widespread literacy in our own language – Biomedical Language – seriously impedes the important process of d- seminating new biomedical knowledge and thereby improving the human condition. It is also a significant personal concern for researchers and clinicians in the highly competitive, publish-or-perish environment of c- temporary academia. Of course, if we are clever or lucky enough to come up with that Nobel Prize-winning discovery, great science will carry the day and we are likely to get published even if our writing is fairly horrid. But most of us who publish are “bread-and-butter” scientists. We compete for space in journals which may only accept 10% or 20% of the submissions that they receive each year. For us, convincing, engaging writing will make the difference between being published or rejected, or at least it will make the difference between being published on ? rst submission or having to go through a number of revisions (or journals). None of this is to propose that good writing can make a silk purse out of a sow’s ear. Scienti? c content is the sine qua non of biomedical writing. |
| clinical research case study examples: 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 case study examples: Clinical Case Studies in Physiotherapy Lauren Jean Guthrie, 2008-10-09 Starting a placement or rotation in an unfamiliar clinical area is exciting but can be daunting. CLINICAL CASE STUDIES IN PHYSIOTHERAPY provides invaluable advice and practical guidance on cases and problems encountered on a daily basis allowing you to work with ease and confidence. By adopting a problem solving approach to the cases through the use of questions and answers, the authors will help you to think constructively about each case within all the key specialities of physiotherapy.Starting a placement or rotation in an unfamiliar clinical area is exciting but can be daunting. CLINICAL CASE STUDIES IN PHYSIOTHERAPY provides invaluable advice and practical guidance on cases and problems encountered on a daily basis allowing you to work with ease and confidence. By adopting a problem solving approach to the cases through the use of questions and answers, the authors will help you to think constructively about each case within all the key specialities of physiotherapy. - Hints and tips to get you ready for clinical placement - How to secure your first physiotherapy post - Case studies in the following clinical areas: respiratory, orthopaedics, neurology, musculoskeletal out-patients, care of the elderly, mental health and womens health - Cases covering paediatrics also included |
| clinical research case study examples: Pharmacy Case Studies Soraya Dhillon, Rebekah Raymond, 2009 Knowledge gained within the individual areas of law and ethics, pharmaceutics, pharmacology and pathology are tested by each example, bringing together all areas taught on the degree course. Each chapter contains five case studies, starting with uncomplicated cases and increasing in complexity as they expand. |
| clinical research case study examples: Clinical Case Studies for the Family Nurse Practitioner Leslie Neal-Boylan, 2011-11-28 Clinical Case Studies for the Family Nurse Practitioner is a key resource for advanced practice nurses and graduate students seeking to test their skills in assessing, diagnosing, and managing cases in family and primary care. Composed of more than 70 cases ranging from common to unique, the book compiles years of experience from experts in the field. It is organized chronologically, presenting cases from neonatal to geriatric care in a standard approach built on the SOAP format. This includes differential diagnosis and a series of critical thinking questions ideal for self-assessment or classroom use. |
| clinical research case study examples: Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings Robyn Tate, Michael Perdices, 2019-01-15 This book is a practical resource designed for clinicians, researchers, and advanced students who wish to learn about single-case research designs. It covers the theoretical and methodological underpinnings of single-case designs, as well as their practical application in the clinical and research neurorehabilitation setting. The book briefly traces the history of single-case experimental designs (SCEDs); outlines important considerations in understanding and planning a scientifically rigorous single-case study, including internal and external validity; describes prototypical single-case designs (withdrawal-reversal designs and the medical N-of-1 trial, multiple-baseline designs, alternating-treatments designs, and changing-criterion designs) and required features to meet evidence standards, threats to internal validity, and strategies to address them; addresses data evaluation, covering visual analysis of graphed data, statistical techniques, and clinical significance; and provides a practical ten-step procedure for implementing single-case methods. Each chapter includes detailed illustrative examples from the neurorehabilitation literature. Novel features include: A focus on the neurorehabilitation setting, which is particularly suitable for single-case designs because of the complex and often unique presentation of many patients/clients. A practical approach to the planning, implementation, data analysis, and reporting of single-case designs. An appendix providing a detailed summary of many recently published SCEDs in representative domains in the neurorehabilitation field, covering basic and instrumental activities of daily living, challenging behaviours, disorders of communication and cognition, mood and emotional functions, and motor-sensory disabilities. It is valuable reading for clinicians and researchers in several disciplines working in rehabilitation, including clinical and neuropsychology, education, language and speech pathology, occupational therapy, and physical therapy. It is also an essential resource for advanced students in these fields who need a textbook for specialised courses on research methodology and use of single-case design in applied clinical and research settings. |
| clinical research case study examples: 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 case study examples: 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 case study examples: Designing Clinical Research Stephen B. Hulley, 2007 This third edition 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 and offers an updated syllabus for conducting a clinical research workshop. |
| clinical research case study examples: Case Studies in Modern Drug Discovery and Development Xianhai Huang, Robert G. Aslanian, 2012-04-19 Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects. |
| clinical research case study examples: Fostering Integrity in Research National Academies of Sciences, Engineering, and Medicine, Policy and Global Affairs, Committee on Science, Engineering, Medicine, and Public Policy, Committee on Responsible Science, 2018-01-13 The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support †or distort †practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices. |
| clinical research case study examples: Clinical Trial Methodology Karl E. Peace, Ding-Geng (Din) Chen, 2010-07-20 Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors' courses on the subject as well as the first author's more than 30 years wor |
| clinical research case study examples: Case Studies in Clinical Psychological Science William O'Donohue, William T. O'Donohue, Scott O. Lilienfeld, 2013-03-14 Case Studies in Clinical Psychological Science demonstrates in detail how the clinical science model can be applied to actual cases. This book's unique structure presents dialogues between leading clinical researchers regarding the treatment of a wide variety of psychological problems. |
| clinical research case study examples: Clinical Research Computing Prakash Nadkarni, 2016-04-29 Clinical Research Computing: A Practitioner's Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. - Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples - Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings - Offers didactic content organization and an increasing complexity through the chapters |
| clinical research case study examples: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders David H. Barlow, Todd J. Farchione, Shannon Sauer-Zavala, Heather Murray Latin, Kristen K. Ellard, Jacqueline R. Bullis, Kate H. Bentley, Hannah T. Boettcher, Clair Cassiello-Robbins, 2017-12-04 Unified Protocol for Transdiagnostic Treatment of Emotional Disorders provides an alternative to disorder-specific treatments of various emotional disorders, designed to be applicable to the wide range of anxiety and other disorders with strong emotional components. |
| clinical research case study examples: Case Study Research John Gerring, 2006-12-11 Case Study Research: Principles and Practices aims to provide a general understanding of the case study method as well as specific tools for its successful implementation. These tools can be utilized in all fields where the case study method is prominent, including business, anthropology, communications, economics, education, medicine, political science, social work, and sociology. Topics include the definition of a 'case study,' the strengths and weaknesses of this distinctive method, strategies for choosing cases, an experimental template for understanding research design, and the role of singular observations in case study research. It is argued that a diversity of approaches - experimental, observational, qualitative, quantitative, ethnographic - may be successfully integrated into case study research. This book breaks down traditional boundaries between qualitative and quantitative, experimental and nonexperimental, positivist and interpretivist. |
| clinical research case study examples: Planning Clinical Research Robert A. Parker, Nancy G. Berman, 2016-10-12 Planning clinical research requires many decisions. The authors of this book explain key decisions with examples showing what works and what does not. |
| clinical research case study examples: 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 case study examples: Clinical Research Lori A. Nesbitt, 2004 As the demand for increased knowledge and new technology continues to unfold, readers will learn how to provide excellent service to research participants with this comprehensive guide. |
| clinical research case study examples: Case Studies in Public Health Theodore H. Tulchinsky, 2018-03-12 Case Studies in Public Health contains selected case studies of some of the most important and influential moments in medicine and epidemiology. The cases chosen for this collection represent a wide array of public health issues that go into the makeup of what can be termed the New Public Health (NPH), which includes traditional public health, such as sanitation, hygiene and infectious disease control, but widens its perspective to include the organization, financing and quality of health care services in a much broader sense. Each case study is presented in a systematic fashion to facilitate learning, with the case, background, current relevance, economic issues, ethical issues, conclusions, recommendation and references discussed for each case. The book is a valuable resource for advanced students and researchers with specialized knowledge who need further information on the general background and history of public health and important scientific discoveries within the field. It is an ideal resource for students in public health, epidemiology, medicine, anthropology, and sociology, and for those interested in how to apply lessons from the past to present and future research. - Explores the history of public health through important scientific events and flashpoints - Presents case studies in a clear, direct style that is easy to follow - Uses a systematic approach to help learn lessons from the past and apply them to the present |
| clinical research case study examples: The Learning Healthcare System Institute of Medicine, Roundtable on Evidence-Based Medicine, 2007-06-01 As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care. |
| clinical research case study examples: A Practical Guide to Managing Clinical Trials JoAnn Pfeiffer, Cris Wells, 2017-05-18 A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is A View from India, a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials. |
| clinical research case study examples: Emerging Infectious Diseases Onder Ergonul, Fusun Can, Murat Akova, Lawrence Madoff, 2014-05-13 More than 30 newly emerged microorganisms and related diseases have been discovered in the past 20 years. Since these infections are so new, even infectious diseases experts and clinical microbiologists need more information. This book covers recently emerged infectious diseases based on real cases and provides comprehensive information including different aspects of the infections. Written in a 'teaching' style, this book is of interest to every medical specialist and student. - Includes more than 35 emerging infection cases based on the following criteria:newly emerged or re-emergedrecently acquired significance in clinical practicerecently radically changed in case management - Offers a balanced synthesis of basic and clinical sciences for each individual case, presenting clinical courses of the cases in parallel with the pathogenesis and detailed microbiological information for each infection - Describes the prevalence and incidence of the global issues and current therapeutic approaches - Presents the measures for infection control |
| clinical research case study examples: Bioethics: Legal and Clinical Case Studies Joseph P. DeMarco, Gary E. Jones, 2017-04-15 Bioethics: Legal and Clinical Case Studies is a case-based introduction to ethical issues in health care. Through seventy-eight compelling scenarios, the authors demonstrate the practical importance of ethics, showing how the concerns at issue bear on the lives of patients, health-care providers, and others. Many central topics are covered, including informed consent, medical futility, reproductive ethics, privacy, cultural competence, and clinical trials. Each chapter includes a selection of important legal cases as well as clinical case studies for critical analysis. The case studies are often presented as moral dilemmas and are conducive to rich discussion. A companion website offers a curated collection of relevant legal precedents along with additional case studies and other resources. |
| clinical research case study examples: Randomised Clinical Trials David Machin, Peter M. Fayers, Bee Choo Tai, 2021-04-27 Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process. This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book: Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting. |
| clinical research case study examples: Evolution of Translational Omics Institute of Medicine, Board on Health Sciences Policy, Board on Health Care Services, Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials, 2012-09-13 Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. |
| clinical research case study examples: 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 case study examples: Clinical Research Manfred Stommel, Celia Wills, 2004 This unique textbook integrates statistical concepts into evidence-based clinical practice and patient management. Research concepts and techniques are drawn from epidemiology, bio-statistics, and psychometrics, as well as educational and social science research. Clinical examples throughout the text illustrate practical and scientifically sound applications of the concepts. Data tables and research vignettes highlight statistical distributions involving probability. Methods to locate and utilize web-based information relevant to clinical research are discussed, and web URLs are provided. Further learning is encouraged by the inclusion of suggested activities, recommended readings, references, and a comprehensive glossary of research terms. Additional resources are available at a Connection Website, connection.LWW.com/go/stommel. |
| clinical research case study examples: Sample Sizes for Clinical Trials Steven A. Julious, 2023-06-21 Sample Sizes for Clinical Trials, Second Edition is a practical book that assists researchers in their estimation of the sample size for clinical trials. Throughout the book there are detailed worked examples to illustrate both how to do the calculations and how to present them to colleagues or in protocols. The book also highlights some of the pitfalls in calculations as well as the key steps that lead to the final sample size calculation. Features: Comprehensive coverage of sample size calculations, including Normal, binary, ordinal, and survival outcome data Covers superiority, equivalence, non-inferiority, bioequivalence and precision objectives for both parallel group and crossover designs Highlights how trial objectives impact the study design with respect to both the derivation of sample formulae and the size of the study Motivated with examples of real-life clinical trials showing how the calculations can be applied New edition is extended with all chapters revised, some substantially, and four completely new chapters on multiplicity, cluster trials, pilot studies, and single arm trials The book is primarily aimed at researchers and practitioners of clinical trials and biostatistics, and could be used to teach a course on sample size calculations. The importance of a sample size calculation when designing a clinical trial is highlighted in the book. It enables readers to quickly find an appropriate sample size formula, with an associated worked example, complemented by tables to assist in the calculations. |
| clinical research case study examples: Research in Practice Martin Terre Blanche, Martin J. Terre Blanche, Kevin Durrheim, Desmond Painter, 2006 A major shift in research methodology from technical to more contextual and pragmatic approaches, this thorough resource incorporates new trends while also providing comprehensive coverage of the full range of established research approaches and techniques, skillfully combining epistemology, methodology, statistics, and application in a volume that is both sophisticated and practical. Placing a greater emphasis on interdisciplinary and applied research skills, this guide encourages the concurrent use of qualitative and quantitative methods and explores such complex topics as ethical issues in social science research; inferential statistical methods; and Marxist, feminist, and black scholarship perspectives. |
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Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of …
CLINICAL definition and meaning | Collins English Dict…
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical …
CLINICAL | meaning - Cambridge Learner's Diction…
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced …
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually …
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Ke…
We pioneer dermatological advancements, collaborating on innovative treatments through …
