Clinical Research Transformed

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Clinical Research Transformed

Olli S. Miettinen,Johann Steurer,Albert Hofman
Clinical Research Transformed Book PDF

Author : Olli S. Miettinen,Johann Steurer,Albert Hofman
Publisher : Springer Nature
Page : 302 pages
File Size : 47,8 Mb
Release : 2019-10-15
Category : Medical
ISBN : 9783030061760

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Clinical Research Transformed by Olli S. Miettinen,Johann Steurer,Albert Hofman Pdf

In this Information Age, the practices of clinical medicine should no longer be based on what clinical doctors actively know. Rather, all of the importantly practice-relevant knowledge should not only already exist but also be codified in cyberspace, in directly practice-guiding 'expert systems' -- for the benefit of both doctors and patients everywhere. Each of these systems (discipline-specific) would, prompted by a particular type of case presentation, present the doctor a questionnaire specific to cases of the type at issue, and document the doctor's answers to the questions. If at issue would be a case of complaint about a (particular type of) sickness, the system would translate the resulting diagnostic profile of the case into the corresponding probabilities of the illnesses to be considered. Similarly, if at issue would be an already-diagnosed case of a particular illness, the system would ask about, and record, the relevant elements in the prognostic profile of the case and then translate this profile into the probabilities of various outcomes to be considered, probabilities specific to the choice of treatment and prospective time in addition to that profile. And besides, these systems would analogously address the causal origin -- etiogenesis -- of cases of particular types of illness. While the requisite knowledge-base for these systems -- notably for the probabilities in them -- has not been addressed by such 'patient-oriented' clinical research as has been conducted (very extensively) up to now, this book delineates the nature of the suitably-transformed research (gnostic). The critically-transformative innovation in the research is the studies' focus on Gnostic Probability Functions -- dia-, etio-, and prognostic -- in the framework of logistic regression models. This book also presents a vision of how this critically-transformative research would most expeditiously be provided for and also conducted, among select sets of academic teaching hospitals.

Transforming Clinical Research in the United States

Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Transforming Clinical Research in the United States Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 151 pages
File Size : 54,5 Mb
Release : 2010-10-22
Category : Medical
ISBN : 9780309163354

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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 Transformed

Olli Sakari Miettinen,Johann Steurer,A. Hofman
Clinical Research Transformed Book PDF

Author : Olli Sakari Miettinen,Johann Steurer,A. Hofman
Publisher : Unknown
Page : 128 pages
File Size : 40,7 Mb
Release : 2019
Category : Clinical medicine
ISBN : 3030061779

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Clinical Research Transformed by Olli Sakari Miettinen,Johann Steurer,A. Hofman Pdf

This book delineates the fundamental transformations that, according to its precepts, are now needed in the objects and methods of 'patient-oriented' clinical research, in order to make it genuinely patient-relevant. These transformations are presented as providing for transition from today's 'evidence-based' practices (advocated by 'clinical epidemiologists') to knowledge-based succedanea of these. While those existing practices vary according to doctors' personal opinions about the burden of the available evidence, their knowledge-based succedanea will be essentially invariant across individual doctors, as they'll be guided by 'expert systems' (imbedded in cyberspace). At issue in this is transformation in what the authors present as the very essence of clinical medicine, namely clinical doctors' esoteric ad-hoc knowing: "gnosis." This is clinical doctors' knowing - probabilistic - about relevant-but-hidden truths about their patients' health, and constitutes the basis for their teaching ("doctoring") the patients about these esoteric insights. The probabilities are 'personalized' in the meaning of their specificity to the cases' gnostic profiles. Genuinely patient-relevant clinical knowledge this book presents as the requisite basis for three species of clinical doctors' gnosis: diagnosis - knowing about whether a particular type of illness is present (though hidden) in the patient; etiognosis - knowing about whether the patient's illness was caused by a particular antecedent of it; and prognosis - knowing about the patient's future health, including as to its dependence on the choice of treatment. Pivotal in gnostic clinical research this book presents to be the studies' objects design in terms of a statistical model for the rate of occurrence of the entity of health in question, in a defined domain of case presentations. The essentials of the studies' methods designs are deduced from their objects designs. Study of this book - on the theory of "meta-epidemiological clinical research" - is essential preparation for teaching 'patient-oriented' clinical research and for actual design & conduct of the studies and of their critical reviews. And by the same token, study of this book is essential preparation for the needed replacement of 'case-based learning' of clinical medicine, for suitably-learned teaching of the practice of clinical medicine - focused on the status quo of the scientific knowledge-base for (gnoses in) the discipline ('specialty') at issue.

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
Neuroscience Trials of the Future Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 111 pages
File Size : 48,7 Mb
Release : 2016-11-07
Category : Medical
ISBN : 9780309442589

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Neuroscience Trials of the Future by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

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.

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
Envisioning a Transformed Clinical Trials Enterprise in the United States Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 248 pages
File Size : 53,5 Mb
Release : 2012-09-13
Category : Medical
ISBN : 9780309253185

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Envisioning a Transformed Clinical Trials Enterprise in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop

National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation
Envisioning a Transformed Clinical Trials Enterprise for 2030 Proceedings of a Workshop Book PDF

Author : National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation
Publisher : National Academies Press
Page : 128 pages
File Size : 48,6 Mb
Release : 2022-08-09
Category : Medical
ISBN : 0309269288

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Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop by National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation Pdf

The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.

Sharing Clinical Trial Data

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Sharing Clinical Trial Data Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 50,6 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

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.

Evidence-Based Medicine and the Changing Nature of Health Care

Institute of Medicine,LeighAnne M. Olsen,Elizabeth G. Nabel,J. Michael McGinnis,Mark B. McClellan
Evidence Based Medicine and the Changing Nature of Health Care Book PDF

Author : Institute of Medicine,LeighAnne M. Olsen,Elizabeth G. Nabel,J. Michael McGinnis,Mark B. McClellan
Publisher : National Academies Press
Page : 202 pages
File Size : 44,8 Mb
Release : 2008-09-06
Category : Medical
ISBN : 9780309113694

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Evidence-Based Medicine and the Changing Nature of Health Care by Institute of Medicine,LeighAnne M. Olsen,Elizabeth G. Nabel,J. Michael McGinnis,Mark B. McClellan Pdf

Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

The Transformation of Academic Health Centers

Steven Wartman
The Transformation of Academic Health Centers Book PDF

Author : Steven Wartman
Publisher : Academic Press
Page : 290 pages
File Size : 47,5 Mb
Release : 2015-03-30
Category : Science
ISBN : 9780128010044

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The Transformation of Academic Health Centers by Steven Wartman Pdf

The Transformation of Academic Health Centers: The Institutional Challenge to Improve Health and Well-Being in Healthcare’s Changing Landscape presents the direct knowledge and vision of accomplished academic leaders whose unique positions as managers of some of the most complex academic and business enterprises make them expert contributors. Users will find invaluable insights and leadership perspectives on healthcare, health professions education, and bio-medical and clinical research that systematically explores the evolving role of global academic health centers with an eye focused on the transformation necessary to be successful in challenging environments. The book is divided into five sections moving from the broad perspective of the role of academic health centers to the role of education, training, and disruptive technologies. It then addresses the discovery processes, improving funding models, and research efficiency. Subsequent sections address the coming changes in healthcare delivery and future perspectives, providing a complete picture of the needs of the growing and influential healthcare sector. Outlines strategies for academic health centers to successfully adapt to the global changes in healthcare and delivery Offers forward-thinking and compelling professional and personal assessments of the evolving role of academic health centers by recognized outstanding academic healthcare leaders Includes case studies and personal reflections, providing lessons learned and new recommendations to challenge leaders Provides discussions on the discovery process, improving funding models, and research efficiency

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
Virtual Clinical Trials Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 127 pages
File Size : 54,7 Mb
Release : 2019-11-16
Category : Medical
ISBN : 9780309494885

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Virtual Clinical Trials by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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 Informatics

Rachel Richesson,James Andrews
Clinical Research Informatics Book PDF

Author : Rachel Richesson,James Andrews
Publisher : Springer Science & Business Media
Page : 415 pages
File Size : 41,9 Mb
Release : 2012-02-15
Category : Medical
ISBN : 9781848824478

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Clinical Research Informatics by Rachel Richesson,James Andrews Pdf

The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

Transforming Clinical Research in the United States

Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Transforming Clinical Research in the United States Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 150 pages
File Size : 43,6 Mb
Release : 2010-11-22
Category : Medical
ISBN : 9780309153324

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Relieving Pain in America

Institute of Medicine,Board on Health Sciences Policy,Committee on Advancing Pain Research, Care, and Education
Relieving Pain in America Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Advancing Pain Research, Care, and Education
Publisher : National Academies Press
Page : 383 pages
File Size : 41,6 Mb
Release : 2011-10-26
Category : Medical
ISBN : 9780309214841

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Relieving Pain in America by Institute of Medicine,Board on Health Sciences Policy,Committee on Advancing Pain Research, Care, and Education Pdf

Chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently underdiagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person's experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps. Pain is a major driver for visits to physicians, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority.

Transforming Global Health

Korydon H. Smith,Pavani Kalluri Ram
Transforming Global Health Book PDF

Author : Korydon H. Smith,Pavani Kalluri Ram
Publisher : Springer Nature
Page : 342 pages
File Size : 48,9 Mb
Release : 2020-02-05
Category : Medical
ISBN : 9783030321123

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Transforming Global Health by Korydon H. Smith,Pavani Kalluri Ram Pdf

This contributed volume motivates and educates across fields about the major challenges in global health and the interdisciplinary strategies for solving them. Once the purview of public health, medicine, and nursing, global health is now an interdisciplinary endeavor that relies on expertise from anthropology to urban planning, economics to political science, geography to engineering. Scholars and practitioners in the health sciences are seeking knowledge from a wider array of fields while, simultaneously, students across majors have a growing interest in humanitarian issues and are pursuing knowledge and skills for impacting well-being across geographic and disciplinary borders. Using a highly practical approach and illustrative case studies, each chapter of this edited volume frames a particular problem and illustrates how interdisciplinary problem-solving can address the greatest challenges in global health today. In doing so, each chapter spurs critical and creative thinking about emergent and future problems. Topics explored among the chapters include: Transforming health and well-being for refugees and their communities Governing to deliver safe and affordable water The global crisis of antimicrobial resistance Low-tech, high-impact interventions to prevent neonatal mortality Communicating taboo health subjects Alternative housing delivery for slum upgrades Transforming Global Health: Interdisciplinary Challenges, Perspectives, and Strategies is a vital and timely compendium for any reader invested in improving global health equity. It will find an audience with researchers, practitioners, policymakers, and program implementers, as well as undergraduate and graduate students and faculty in the fields of global health, public health, and the health sciences.

Fundamentals of Clinical Trials

Lawrence M. Friedman,Curt Furberg,David L. DeMets
Fundamentals of Clinical Trials Book PDF

Author : Lawrence M. Friedman,Curt Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Page : 384 pages
File Size : 40,5 Mb
Release : 1998
Category : Clinical trials
ISBN : 0387985867

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Fundamentals of Clinical Trials by Lawrence M. Friedman,Curt Furberg,David L. DeMets Pdf

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.