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Brain Imaging in the Evaluation of Putative Alzheimer’s Disease-Slowing, Risk-Reducing and Prevention Therapies

Eric M. Reiman and Jessica B. S. Langbaum

in Imaging the Aging Brain

Published in print:
2009
Published Online:
February 2010
ISBN:
9780195328875
eISBN:
9780199864836
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195328875.003.0020
Subject:
Neuroscience, Techniques, Development

This chapter describes the emerging roles of brain imaging and other biomarker measurements of Alzheimer's disease (AD) progression and pathology in the evaluation of putative AD-slowing, ... More


Clinical Trials in Neurology

Lorene M. Nelson, Caroline M. Tanner, Stephen K. Van Den Eeden, and Valerie M. McGuire

in Neuroepidemiology: From principles to practice

Published in print:
2004
Published Online:
September 2009
ISBN:
9780195133790
eISBN:
9780199863730
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195133790.003.17
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This chapter provides extensive coverage of concepts related to controlled clinical trials in neurology. It describes the main issues in clinical trial design, conduct, and analysis, by examples from ... More


Enrolment in clinical trials

Richard Brown and Terrance L Albrecht

in Handbook of Communication in Oncology and Palliative Care

Published in print:
2010
Published Online:
November 2011
ISBN:
9780199238361
eISBN:
9780191730290
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199238361.003.0020
Subject:
Palliative Care, Patient Care and End-of-Life Decision Making, Palliative Medicine Research

Despite recent advances, the five-year survival rates for many cancers remains low, and there is a continued need for research to improve cancer outcomes. Clinical trials represent the gold standard ... More


Clinical–ethical implications and applications

Fabrizio Benedetti

in Placebo Effects: Understanding the mechanisms in health and disease

Published in print:
2008
Published Online:
September 2009
ISBN:
9780199559121
eISBN:
9780191724022
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199559121.003.0010
Subject:
Neuroscience, Molecular and Cellular Systems

The recent neurobiological advances in placebo research can stimulate the development of new clinical trial designs for the validation of new treatments, and lead to an uncertainty principle, whereby ... More


Principles of designing clinical trials in palliative care

Michael I. Bennett

in Research Methods in Palliative Care

Published in print:
2007
Published Online:
November 2011
ISBN:
9780198530251
eISBN:
9780191729980
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780198530251.003.0002
Subject:
Palliative Care, Palliative Medicine Research, Patient Care and End-of-Life Decision Making

Clinical practice in palliative care is focused primarily on improving the quality of life for people that are facing advanced and incurable disease. As such, clinical trials are used to test and ... More


Global Trends Toward Transparency in Participant-Level Clinical Trials Data

Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer

in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0009
Subject:
Law, Medical Law

In this chapter, the authors review recent regulatory and private efforts focused on broadening access to participant-level data collected as part of clinical trials. The authors consider the risks ... More


Children in clinical trials in Ireland: addressing the gaps in the legal framework

Katherine Wade

in Ethical and Legal Debates In Irish Healthcare: Confronting complexities

Published in print:
2016
Published Online:
May 2016
ISBN:
9780719099465
eISBN:
9781526104410
Item type:
chapter
Publisher:
Manchester University Press
DOI:
10.7228/manchester/9780719099465.003.0012
Subject:
Sociology, Culture

This chapter focuses on two key areas which require further clarity and elaboration in the context of research with children, namely, the requirements for research which does not offer the child the ... More


Imaging Applications to Parkinson’s Disease Clinical Trials

Martin Niethammer and Andrew Feigin

in Imaging in Parkinson’s Disease

Published in print:
2011
Published Online:
September 2011
ISBN:
9780195393484
eISBN:
9780199914494
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195393484.003.0119
Subject:
Neuroscience, Disorders of the Nervous System, Techniques

This chapter reviews the role of neuroimaging in PD clinical trials to investigate both symptomatic and potential disease-modifying therapies. While clinical ratings are typically used as the primary ... More


The traditional concept of placebo

Fabrizio Benedetti

in Placebo Effects: Understanding the mechanisms in health and disease

Published in print:
2008
Published Online:
September 2009
ISBN:
9780199559121
eISBN:
9780191724022
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199559121.003.0001
Subject:
Neuroscience, Molecular and Cellular Systems

The history of medicine is basically the history of placebos, as most early medical interventions were nothing but placebos, i.e., inert. Over the centuries, doctors started using sham treatments to ... More


Shopping for a Trial?

Curtis L. Meinert

in An Insider’s Guide to Clinical Trials

Published in print:
2011
Published Online:
September 2011
ISBN:
9780199742967
eISBN:
9780199897278
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199742967.003.0020
Subject:
Public Health and Epidemiology, Epidemiology, Public Health

This chapter presents guidelines for persons in search of a clinical trial to enroll in. By and large, one should be shopping for randomized trials because two things are certain: firstly, that there ... More


The decision to decline to enrol in a clinical trial: a blind spot in the literature on decision-making for research participation

Claire Snowdon, Diana Elbourne, and Jo Garcia

in The Limits of Consent: A socio-ethical approach to human subject research in medicine

Published in print:
2009
Published Online:
September 2009
ISBN:
9780199231461
eISBN:
9780191723858
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199231461.003.0004
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This chapter examines the decisions of parents of critically ill babies who had not consented to take part in research. Their decisions were based on a misunderstanding of the information they had ... More


Ethical and practical issues in designing and conducting clinical trials in palliative care

Yolanda Zuriarrain Reyna, Mchael I. Bennett, and Eduardo Bruera

in Research Methods in Palliative Care

Published in print:
2007
Published Online:
November 2011
ISBN:
9780198530251
eISBN:
9780191729980
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780198530251.003.0003
Subject:
Palliative Care, Palliative Medicine Research, Patient Care and End-of-Life Decision Making

This chapter discusses certain ethical and practical issues involved in designing and conducting clinical trials in palliative care. It also highlights several ethical, administrative, and ... More


‘… disavowing the tree’

William A. Silverman

in Where's the Evidence?: Debates in Modern Medicine

Published in print:
1999
Published Online:
September 2009
ISBN:
9780192630889
eISBN:
9780191723568
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780192630889.003.0013
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This chapter presents a 1990 commentary on two clinical trials conducted in Kuala Lumpur and the US. A comparison of the trials provides supporting evidence for the claim that there has been ... More


How Did Médecins Sans Frontières Negotiate Clinical Trials of Unproven Treatments During the 2014–2015 Ebola Epidemic?

Annette Rid and Annick Antierens

in The Politics of Fear: Médecins sans Frontières and the West African Ebola Epidemic

Published in print:
2017
Published Online:
February 2017
ISBN:
9780190624477
eISBN:
9780190624507
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780190624477.003.0008
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

In 2014, the world began to witness an unprecedented Ebola epidemic in West Africa that is now smoldering. Ebola had a fatality rate of 40% to 60% in this epidemic due to a lack of adequate health ... More


Introduction

Curtis L. Meinert and Susan Tonascia

in Clinical Trials: Design, Conduct and Analysis

Published in print:
1986
Published Online:
September 2009
ISBN:
9780195035681
eISBN:
9780199864478
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195035681.003.0001
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This introduction chapter begins with a brief discussion of the definition of a clinical trial. It then presents a historical sketch of clinical trials followed by a terminology of conventions. The ... More


Trials and Tribulations

Michael Kinch

in Prescription for Change: The Looming Crisis in Drug Development

Published in print:
2016
Published Online:
May 2017
ISBN:
9781469630625
eISBN:
9781469630649
Item type:
chapter
Publisher:
University of North Carolina Press
DOI:
10.5149/northcarolina/9781469630625.003.0003
Subject:
Business and Management, Innovation

The testing of new medicines is a complex, labor- and cost-intensive practice that has evolved over the past 200 years. This chapter explains some of the jargon used by medical practioners and ... More


Begin with ‘If…’

William A. Silverman

in Where's the Evidence?: Debates in Modern Medicine

Published in print:
1999
Published Online:
September 2009
ISBN:
9780192630889
eISBN:
9780191723568
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780192630889.003.0009
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This chapter presents a 1989 commentary on randomized clinical trials. It argues that given the uncertainties about the wide extrapolation of results after any and all formal clinical studies, it ... More


Introduction

Curtis L. Meinert

in An Insider’s Guide to Clinical Trials

Published in print:
2011
Published Online:
September 2011
ISBN:
9780199742967
eISBN:
9780199897278
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199742967.003.0001
Subject:
Public Health and Epidemiology, Epidemiology, Public Health

This introductory chapter begins with a brief description of the origins of the term clinical trial and the concept of randomization. It then details the development of modern-day clinical trials, ... More


16. Experimental studies: clinical trials, field trials, community trials, and intervention studies

Barrie M. Margetts and Ian L. Rouse

in Design Concepts in Nutritional Epidemiology

Published in print:
1997
Published Online:
September 2009
ISBN:
9780192627391
eISBN:
9780191723704
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780192627391.003.0016
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

Experimental studies set out to alter, rather than just observe, relevant exposures of interest, and to assess over time their impact on health status or disease outcomes. This chapter begins with an ... More


An Insider’s Guide to Clinical Trials

Curtis L Meinert

Published in print:
2011
Published Online:
September 2011
ISBN:
9780199742967
eISBN:
9780199897278
Item type:
book
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199742967.001.0001
Subject:
Public Health and Epidemiology, Epidemiology, Public Health

Clinical trials receive a lot of media attention; we hear or read about them almost daily in reports heralding new and promising treatments or reports raising questions about the safety or efficacy ... More


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