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Reproducibility In Biomedical Research

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Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting

Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting Book
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,National Cancer Policy Forum,Forum on Neuroscience and Nervous System Disorders,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release : 2020-05-28
ISBN : 0309663490
Language : En, Es, Fr & De

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Book Description :

Sharing knowledge is what drives scientific progress - each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted as credible by the scientific community, they must be verified by other researchers. An essential step is for researchers to report their findings in a manner that is understandable to others in the scientific community and provide sufficient information for others to validate the original results and build on them. In recent years, concern has been growing over a number of studies that have failed to replicate previous results and evidence from larger meta-analyses, which have pointed to the lack of reproducibility in biomedical research. On September 25 and 26, 2019, the National Academies of Science, Engineering, and Medicine hosted a public workshop in Washington, DC, to discuss the current state of transparency in the reporting of preclinical biomedical research and to explore opportunities for harmonizing reporting guidelines across journals and funding agencies. Convened jointly by the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health, the workshop primarily focused on transparent reporting in preclinical research, but also considered lessons learned and best practices from clinical research reporting. This publication summarizes the presentation and discussion of the workshop.

Reproducibility in Biomedical Research

Reproducibility in Biomedical Research Book
Author : Erwin B. Montgomery
Publisher : Academic Press
Release : 2019-03-15
ISBN : 9780128174432
Language : En, Es, Fr & De

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Book Description :

Reproducibility in Biomedical Research explores the ideas and conundrums inherent in scientific research. Reproducibility is a significant concern within biomedical research. How can any biomedical researcher be sure her or his research will not be found reproducible or been compromised by the potentially irreproducible work of other scientists on which she or he depends? Within this concern lies the question of multiple types of reproducibility and how research becomes irreproducible. Contributing factors have often been confined to considerations of fraud, transparency, or statistical rigor; however, there evidence of other factors including experimental design and logic used. This book explores factors of reproducibility including logic, distinguishing productive from unproductive irreproducibility, the scientific method, and the use of statistics. In multiple examples and six detailed case studies, this book demonstrates the misuse of logic resulting in unproductive irreproducibility, allowing researchers to develop their own logic and planning abilities. Biomedical researchers, clinicians, administrators of scientific institutions and funding agencies, journal editors, philosophers of science and medicine will find the arguments and explorations of Reproducibility in Biomedical Research a valuable addition to their libraries. Considers the meaning and purpose of reproducibility to help design research Reviews famous case studies of alleged irreproducibility to determine if these could be reproducible Provides a theoretical aspect to the practical issues surrounding research design and conduct

Research in the Biomedical Sciences

Research in the Biomedical Sciences Book
Author : Michael Williams,Michael Curtis,Kevin Mullane
Publisher : Academic Press
Release : 2017-10-20
ISBN : 0128047267
Language : En, Es, Fr & De

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Book Description :

Research in the Biomedical Sciences: Transparent and Reproducible documents the widespread concerns related to reproducibility in biomedical research and provides a best practices guide to effective and transparent hypothesis generation, experimental design, reagent standardization (including validation and authentication), statistical analysis, and data reporting. The book addresses issues in the perceived value of the existing peer review process and calls for the need for improved transparency in data reporting. It reflects new guidelines for publication that include manuscript checklists, replication/reproducibility initiatives, and the potential consequences for the biomedical research community and societal health and well-being if training, mentoring, and funding of new generations of researchers and incentives for publications are not improved. This book offers real world examples, insights, and solutions to provide a thought-provoking and timely resource for all those learning about, or engaged in, performing and supervising research across the biomedical sciences. Provides a “big picture perspective on the scope of reproducibility issues and covers initiatives that have potential as effective solutions Offers real-world research context for transparent, reproducible experimental design, execution and reporting of biomedical research with the potential to address aspects of the translational gap in drug discovery Highlights the importance of reproducibility and the necessary changes in biomedical and pharmaceutical research training and incentives to ensure sustainability

Reproducibility in Biomedical Research

Reproducibility in Biomedical Research Book
Author : Erwin B. Montgomery
Publisher : Academic Press
Release : 2019-03-14
ISBN : 0128176725
Language : En, Es, Fr & De

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Book Description :

Reproducibility in Biomedical Research: Epistemological and Statistical Problems explores the ideas and conundrums inherent in scientific research. It explores factors of reproducibility, including logic, distinguishing productive from unproductive irreproducibility, the scientific method, and the use of statistics. In multiple examples and six detailed case studies, the book demonstrates the misuse of logic resulting in unproductive irreproducibility, allowing researchers to develop their own logic and planning abilities. Biomedical researchers, clinicians, administrators of scientific institutions and funding agencies, journal editors, philosophers of science and medicine will find the arguments and explorations a valuable addition to their libraries. Considers the meaning and purpose of reproducibility to help design research Reviews famous case studies of alleged irreproducibility to determine if these could be reproducible Provides a theoretical aspect to practical issues surrounding research design and conduct

Reproducibility in A I for Biomedical Research an Application to Parkinson s Disease

Reproducibility in A I  for Biomedical Research  an Application to Parkinson s Disease Book
Author : Christian Lee McDaniel
Publisher : Unknown
Release : 2019
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Deep learning-based data analysis techniques have found many uses in biomedical re- search. Recent expansion of open source databases and computational tools has fostered distributed and explorative research. Under these conditions, reproducibil- ity and experimental rigor must be ensured. Developing explicit analysis pipelines exposes the scientific process and yields reproducible results. In this thesis, we look at the case of deep learning-based data analysis for Parkinson's disease (PD) research. We develop end-to-end pipelines in two PD-related fields: accelerometer data analysis and neuroimage analysis. First, we construct a simple yet robust recurrent neural network for classifying motor activity from accelerometer data alone; this has applications for identifying the mo- tor symptoms of PD. Next, we propose a novel graph convolutional network architecture for distinguishing PD patients vs. healthy controls from multimodal neuroimage data. Our pipelines standardize the data preprocessing and analysis steps, fostering reproducibility and deliberate progression of their respective fields.

Development of Strategies for Assessing Reporting in Biomedical Research

Development of Strategies for Assessing Reporting in Biomedical Research Book
Author : Oscar Florez Vargas
Publisher : Unknown
Release : 2016
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Development of Strategies for Assessing Reporting in Biomedical Research book written by Oscar Florez Vargas, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Interpreting Biomedical Science

Interpreting Biomedical Science Book
Author : Ülo Maiväli
Publisher : Academic Press
Release : 2015-06-12
ISBN : 0124199569
Language : En, Es, Fr & De

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Book Description :

Interpreting Biomedical Science: Experiment, Evidence, and Belief discusses what can go wrong in biological science, providing an unbiased view and cohesive understanding of scientific methods, statistics, data interpretation, and scientific ethics that are illustrated with practical examples and real-life applications. Casting a wide net, the reader is exposed to scientific problems and solutions through informed perspectives from history, philosophy, sociology, and the social psychology of science. The book shows the differences and similarities between disciplines and different eras and illustrates the concept that while sound methodology is necessary for the progress of science, we cannot succeed without a right culture of doing things. Features theoretical concepts accompanied by examples from biological literature Contains an introduction to various methods, with an emphasis on statistical hypothesis testing Presents a clear argument that ties the motivations and ethics of individual scientists to the success of their science Provides recommendations on how to safeguard against scientific misconduct, fraud, and retractions Arms young scientists with practical knowledge that they can use every day

MEDINFO 2019 Health and Wellbeing e Networks for All

MEDINFO 2019  Health and Wellbeing e Networks for All Book
Author : L. Ohno-Machado,B. Séroussi
Publisher : IOS Press
Release : 2019-11-12
ISBN : 164368003X
Language : En, Es, Fr & De

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Book Description :

Combining and integrating cross-institutional data remains a challenge for both researchers and those involved in patient care. Patient-generated data can contribute precious information to healthcare professionals by enabling monitoring under normal life conditions and also helping patients play a more active role in their own care. This book presents the proceedings of MEDINFO 2019, the 17th World Congress on Medical and Health Informatics, held in Lyon, France, from 25 to 30 August 2019. The theme of this year’s conference was ‘Health and Wellbeing: E-Networks for All’, stressing the increasing importance of networks in healthcare on the one hand, and the patient-centered perspective on the other. Over 1100 manuscripts were submitted to the conference and, after a thorough review process by at least three reviewers and assessment by a scientific program committee member, 285 papers and 296 posters were accepted, together with 47 podium abstracts, 7 demonstrations, 45 panels, 21 workshops and 9 tutorials. All accepted paper and poster contributions are included in these proceedings. The papers are grouped under four thematic tracks: interpreting health and biomedical data, supporting care delivery, enabling precision medicine and public health, and the human element in medical informatics. The posters are divided into the same four groups. The book presents an overview of state-of-the-art informatics projects from multiple regions of the world; it will be of interest to anyone working in the field of medical informatics.

Career Advice for Young Scientists in Biomedical Research

Career Advice for Young Scientists in Biomedical Research Book
Author : Béla Z. Schmidt
Publisher : Springer Nature
Release : 2021-12-02
ISBN : 3030855716
Language : En, Es, Fr & De

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Book Description :

Pursuing a career in biomedical research can be daunting, considering the stiffer competition and uncertain career prospects in academia. This book summarizes career advice gathered during in-depth interviews with 106 biomedical scientists who lead their own laboratories. The participating principal investigators are from 44 research institutions in 11 countries. This book is unique in that it provides a glimpse into the mindset of principal investigators. Here, the reader will learn about common thought patterns and values, as well as the range of opinions and ways of thinking to be found among a large group of active principal investigators – without having to read more than a hundred individual autobiographies. The book will benefit all PhD students who want to learn more about their supervisor’s mindset in order to successfully complete their projects. It can help freshly graduated PhDs planning to pursue an academic career, and MDs contemplating a career in research, to decide whether they truly want to embark on this path. Lastly, it can offer young principal investigators a source of inspiration on how to succeed and achieve their goals.

Reproducible Research in Pattern Recognition

Reproducible Research in Pattern Recognition Book
Author : Bertrand Kerautret,Miguel Colom,Pascal Monasse
Publisher : Springer
Release : 2017-04-04
ISBN : 3319564145
Language : En, Es, Fr & De

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Book Description :

This book constitutes the thoroughly refereed post-proceedings of the First International Workshop on Reproducible Research in Pattern Recognition, RRPR 2016, held in Cancún, Mexico, in December 2016. The 12 revised full papers, among them 2 invited talks, presented were carefully reviewed and selected from 16 submissions. They focus on pattern recognition algorithms; reproducible research frameworks; reproducible research results, previous works on reproducible research.

Reproducibility

Reproducibility Book
Author : Edo D. Pellizzari,Kathleen N. Lohr,Alan Blatecky,Darryl V. Creel
Publisher : RTI Press
Release : 2017
ISBN : 1934831212
Language : En, Es, Fr & De

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Book Description :

Science is allegedly in the midst of a reproducibility crisis, but questions of reproducibility and related principles date back nearly 80 years. Numerous controversies have arisen, especially since 2010, in a wide array of disciplines that stem from the failure to reproduce studies or their findings:biology, biomedical and preclinical research, business and organizational studies, computational sciences, drug discovery, economics, education, epidemiology and statistics, genetics, immunology, policy research, political science, psychology, and sociology. This monograph defines terms and constructs related to reproducible research, weighs key considerations and challenges in reproducing or replicating studies, and discusses transparency in publications that can support reproducible research goals. It attempts to clarify reproducible research, with its attendant (and confusing or even conflicting) lexicon and aims to provide useful background, definitions, and practical guidance for all readers. Among its conclusions: First, researchers must become better educated about these issues, particularly the differences between the concepts and terms. The main benefit is being able to communicate clearly within their own fields and, more importantly, across multiple disciplines. In addition, scientists need to embrace these concepts as part of their responsibilities as good stewards of research funding and as providers of credible information for policy decision making across many areas of public concern. Finally, although focusing on transparency and documentation is essential, ultimately the goal is achieving the most rigorous, high-quality science possible given limitations on time, funding, or other resources. “The authors have written a nuanced and thoughtful primer on scientific reproducibility. By highlighting the social, political, and technical importance of reproducibility, together with a precise description of the related concepts of reproducibility, replicability, and repeatability, this primer provides a significant resource that all practicing researchers should read.” Daniel Reed, Vice President for Research and Economic Development, University of Iowa and former Corporate Vice President, Microsoft “This is a well-written, clearly articulated, and timely primer on the developing and evolving rich terminology of reproducible research. The primer, put together by authors with deep experience and expertise in the topic area, focuses primarily on human-centric research in biomedicine, medicine, and the social sciences as well as reproducibility issues in analytics and computational science. The growing focus on reproducibility will open new vistas in research methodologies, meta analysis, comparative studies of research results, and reuse and adaptation of results from prior research. This primer provides an excellent overview of the subject area, and I would recommend it to anyone interested in coming up to speed on current issues in reproducible research.” Chaitan Baru, Distinguished Scientist and Associate Director for Data Initiatives, San Diego Supercomputing Center; current appointment as Senior Advisor for Data Science, Computer and Information Science and Engineering Directorate, National Science Foundation “Pellizzari et al. have taken on the Herculean task of collecting, synthesizing, and relating the various interpretations of reproducibility used in the research community today, and turned the result into an accessible must-read guide. This important work provides a Rosetta Stone for various stakeholders to discuss and implement solutions that make real progress toward a research enterprise that routinely produces reproducible findings.” Victoria Stodden, Associate Professor at the School of Information Sciences, University of Illinois at Urbana Champaign and co-editor of the books Implementing Reproducible Research and Privacy, Big Data, and the Public Good: Frameworks for Engagement

Experimental Design for Laboratory Biologists

Experimental Design for Laboratory Biologists Book
Author : Stanley E. Lazic
Publisher : Cambridge University Press
Release : 2016-12-08
ISBN : 1316810674
Language : En, Es, Fr & De

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Book Description :

Specifically intended for lab-based biomedical researchers, this practical guide shows how to design experiments that are reproducible, with low bias, high precision, and widely applicable results. With specific examples from research using both cell cultures and model organisms, it explores key ideas in experimental design, assesses common designs, and shows how to plan a successful experiment. It demonstrates how to control biological and technical factors that can introduce bias or add noise, and covers rarely discussed topics such as graphical data exploration, choosing outcome variables, data quality control checks, and data pre-processing. It also shows how to use R for analysis, and is designed for those with no prior experience. An accompanying website (https://stanlazic.github.io/EDLB.html) includes all R code, data sets, and the labstats R package. This is an ideal guide for anyone conducting lab-based biological research, from students to principle investigators working in either academia or industry.

Getting to Good

Getting to Good Book
Author : Arthur L. Caplan,Barbara K. Redman
Publisher : Springer
Release : 2018-07-23
ISBN : 3319513583
Language : En, Es, Fr & De

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Book Description :

This book represents the first comprehensive, gold standard reader on research integrity in the biomedical sciences. Now more than ever, the responsible conduct of research (RCR) has become critically important as new technologies affect research practices in both positive and negative ways. Since learning to do science and practicing it brings researchers into contact with a vast array of ethical issues, it is critical to know the standards and how they are evolving. Indeed, research integrity requires scientists at all levels to operate ethically in a system that supports ethical practice. This unique, foundational text covers all the relevant areas -- subject protection, research misconduct and conflict of interest as well as newly quantified concerns about research bias and non-reproducibility, as well as other unique issues. Developed by renowned experts, this compelling title discusses the full range of practices and policies that should support research that is honestly produced and disseminated. It also specifically incorporates topics noted by the National Institutes of Health as essential and required for training in RCR. Getting to Good – Research Integrity in the Biomedical Sciences is a major contribution to the literature on bioethics and will serve as an invaluable resource for all researchers, students, administrators and professionals interested in research ethics and integrity.

On the Move to Meaningful Internet Systems OTM 2017 Conferences

On the Move to Meaningful Internet Systems  OTM 2017 Conferences Book
Author : Hervé Panetto,Christophe Debruyne,Walid Gaaloul,Mike Papazoglou,Adrian Paschke,Claudio Agostino Ardagna,Robert Meersman
Publisher : Springer
Release : 2017-10-20
ISBN : 3319694596
Language : En, Es, Fr & De

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Book Description :

This double volumes LNCS 10573-10574 constitutes the refereed proceedings of the Confederated International Conferences: Cooperative Information Systems, CoopIS 2017, Ontologies, Databases, and Applications of Semantics, ODBASE 2017, and Cloud and Trusted Computing, C&TC, held as part of OTM 2017 in October 2017 in Rhodes, Greece. The 61 full papers presented together with 19 short papers were carefully reviewed and selected from 180 submissions. The OTM program every year covers data and Web semantics, distributed objects, Web services, databases, information systems, enterprise workflow and collaboration, ubiquity, interoperability, mobility, grid and high-performance computing.

Roundtable on Data Science Postsecondary Education

Roundtable on Data Science Postsecondary Education Book
Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Division on Engineering and Physical Sciences,Board on Science Education,Computer Science and Telecommunications Board,Committee on Applied and Theoretical Statistics,Board on Mathematical Sciences and Analytics
Publisher : National Academies Press
Release : 2020-10-02
ISBN : 030967770X
Language : En, Es, Fr & De

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Book Description :

Established in December 2016, the National Academies of Sciences, Engineering, and Medicine's Roundtable on Data Science Postsecondary Education was charged with identifying the challenges of and highlighting best practices in postsecondary data science education. Convening quarterly for 3 years, representatives from academia, industry, and government gathered with other experts from across the nation to discuss various topics under this charge. The meetings centered on four central themes: foundations of data science; data science across the postsecondary curriculum; data science across society; and ethics and data science. This publication highlights the presentations and discussions of each meeting.

Experimental Design and Reproducibility in Preclinical Animal Studies

Experimental Design and Reproducibility in Preclinical Animal Studies Book
Author : José M. Sánchez Morgado,Aurora Brønstad
Publisher : Springer Nature
Release : 2021
ISBN : 3030661474
Language : En, Es, Fr & De

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Book Description :

This highly-readable text provides grounds on how to plan and conduct animal experiments that can be reproduced by others. The book touches on factors that may impact the reproducibility of animal studies including: the animal genetic background, the animal microbial flora, environmental and physiological variables affecting the animal, animal welfare, statistics and experimental design, systematic reviews of animal studies, and the publishing process. The book addresses advanced undergraduates, graduate students and all scientists working with animals.

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants Book
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories
Publisher : National Academies Press
Release : 2018-09-23
ISBN : 0309475171
Language : En, Es, Fr & De

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Book Description :

When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine Book
Author : Claudio Carini,Mark Fidock,Alain van Gool
Publisher : CRC Press
Release : 2019-04-16
ISBN : 0429576730
Language : En, Es, Fr & De

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Book Description :

"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Medical Reasoning

Medical Reasoning Book
Author : Erwin B. Montgomery
Publisher : Oxford University Press, USA
Release : 2018-11-14
ISBN : 0190912928
Language : En, Es, Fr & De

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Book Description :

Modern medicine is one of humankind's greatest achievements.Yet today, frequent medical errors and irreproducibility in biomedical research suggest that tremendous challenges beset it. Understanding these challenges and trying to remedy them have driven considerable and thoughtful critical analyses, but the apparent intransigence of these problems suggests a different perspective is needed. Now more than ever, when we see options and opportunities for healthcare expanding while resources are diminishing, it is extremely important that healthcare professionals practice medicine wisely. In Medical Reasoning, neurologist Erwin B. Montgomery, Jr. offers a new and vital perspective. He begins with the idea that the need for certainty in medical decision-making has been the primary driving force in medical reasoning. Doctors must routinely confront countless manifestations of symptoms, diseases, or behaviors in their patients. Therefore, either there are as many different "diseases" as there are patients or some economical set of principles and facts can be combined to explain each patient's disease. The response to this epistemic conundrum has driven medicine throughout history: the challenge is to discover principles and facts and then to develop means to apply them to each unique patient in a manner that provides certainty. This book studies the nature of medical decision making systematically and rigorously in both an analytic and historical context, addressing medicine's unique need for certainty in the face of the enormous variety of diseases and in the manifestations of the same disease in different patients. The book also examines how the social, legal, and economic circumstances in which medical decision-making occurs greatly influence the nature of medical reasoning. Medical Reasoning is essential for those at the intersection of healthcare and philosophy.

Access to Non Summary Clinical Trial Data for Research Purposes Under EU Law

Access to Non Summary Clinical Trial Data for Research Purposes Under EU Law Book
Author : Daria Kim
Publisher : Springer Nature
Release : 2021-11-20
ISBN : 3030867781
Language : En, Es, Fr & De

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Book Description :

This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.