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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3091_Библиотеки_им_академика_М_И_Перельмана
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289
Tal J (2011) Strategy and statistics in clinical trials. A non-statisticians guide to
thinking, designing and executing. Academic Press, Cambridge
The focus is on the research process and the role of statistics in these processes. It
describes the statistical building blocks and concepts of clinical trials and promotes
effective cooperation between statisticians and other important parties. Topics
include the link between research objectives and statistical thinking, estimation,
testing procedures, statistical signicance, explanation, and prediction. It distin-
guishes between exploratory and conrmatory trials, describes the tension between
hypothesis testing and multiplicity, and outlines basic elements of clinical trials,
choice of endpoints, and determination of sample size. [Author Note: Useful for any
non-statistician who is interested in obtaining a better basic understanding of how
statistics are applied to clinical trials.]
Browner WS (2012) Publishing & presenting clinical research, 3rd edn.
Lippincott Williams & Wilkins, Philadelphia
This book explains the essentials of clinical trials and and how to publish them. It is
perfect for investigators who seek information on how to organize, deliver, and pub-
lish the outcomes of their trials in the most effective way. It includes topics on how
to make clear oral presentations and details on how to prepare manuscripts, tables,
and abstracts for publication. [Author Note: The unique focus of this book is on
publication and presentation of clinical trial results, an important but neglected area
in clinical trial methods.]
Harrington D (2012) Designs for clinical trials. Perspectives on current issues.
Springer, NewYork
This edited volume is an examination of current issues and controversies in the
design of clinical trials, including topics in adaptive and sequential designs, the
design of correlative genomic studies, the design of studies in which missing data
are anticipated, and interim monitoring for futility. As a collection, the chapters
serve as guidance for statisticians designing clinical trials. [Author Note: The book
is written by a biostatistician who is a recognized and respected leader in statistical
methods for clinical trials and an expert in data coordinating centers.]
Meinert CL (2012) Clinical trials dictionary: terminology and usage recom-
mendations, 2nd edn. Wiley, Hoboken
This book provides clear, precise, and detailed entries on all aspects of modern-day
clinical trials, incorporating the disciplines of medicine, statistics, epidemiology,
computer science, and bioethics. It supplies readers with A–Z terminology needed
to design, conduct, and analyze trials. It features historical gures and institutions
in the eld, and an extensive bibliography for additional resources. [Author Note:
This book is written by one of the world’s leading clinical trialists and is a valuable
resource for developing a comprehensive understanding of trial terminology and the
range of considerations needed to maximize the strength of a clinical trial.]
Appendix: Books onClinical Trials
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290
van Belle G, Kerr KF (2012) Design and analysis of experiments in the health
sciences. Wiley, Hoboken
This book advances the idea that design drives analysis and analysis reveals the
design. It explains how to apply design and analysis principles in animal, human,
and laboratory experiments while illustrating topics with examples from random-
ized clinical trials. The authors focus on ve types of designs that form the basis of
most experimental structures: completely randomized designs, randomized block
designs, factorial designs, multilevel experiments, and repeated measures designs.
A website features data sets that are used throughout the book and allow readers
hands-on applications, and an extensive bibliography outlines additional resources
for further study. [Author Note: The theme of this book is the intimate connection
between design and analysis. The ve designs presented are the most common
designs in clinical trials.]
Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB (2013)
Designing clinical research, 4th edn. Lippincott Williams & Wilkins,
Philadelphia
This book continues to set the standard as a practical guide for doctors, nurses,
pharmacists, and other health professionals involved in all forms of clinical, trans-
lational, and public health research. It presents advanced epidemiologic concepts in
a reader-friendly way and provides common sense approaches to the challenging
judgments involved in designing, funding, and implementing a clinical trial. [Author
Note: This book integrates epidemiological concepts with clinical trial methodol-
ogy. It is among the top books on clinical trials, written by a leader of, and com-
mentator on, some of the most inuential behavioral efcacy trials to date.]
Meinert CL (2013) Clinical trials handbook. Design and conduct.
Wiley, Hoboken
The success or failure of clinical trials hinges on hundreds of details that need to be
developed, often under less than ideal conditions. This is a systematic approach to
all aspects of designing clinical trials, with a focus on simplifying the process and
avoiding costly mistakes. Topics include masking, randomization, consent, enroll-
ment, eligibility, sample size, data collection, working with study centers and
research staff, monitoring, and data analysis. [Author Note: This book is written by
one of the world’s leading trialists as a companion to the Clinical Trials Dictionary.
It provides insights from an experienced expert into the complexity and range of
decisions needed in a clinical trial and how to make them.]
Appendix: Books onClinical Trials
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291
Friedman LM, Furberg CD, DeMets D, Reboussin DM, Granger CB (2015)
Fundamentals of clinical trials, 5th edn. Springer, Cham
The clinical trial is the most denitive tool for comparing the potential for alterna-
tive treatments to improve health, improve the quality of health care, and control
costs. It has been called “the gold standard” against which all other clinical research
works are measured. Although many clinical trials are of high quality, a careful
reader of the medical literature will notice a large number of deciencies in design,
conduct, analysis, presentation, and/or interpretation of results. Improvements have
occurred over the past few decades, but too many trials are still conducted without
adequate attention to the fundamental principles, suggesting that attention to these
fundamentals is needed. The fth edition adds two new authors, a chapter on regula-
tory issues, more detail on data monitoring, contemporary clinical trial examples,
and new material on adverse events, adherence, analysis, electronic data sharing,
and international trials. [Author Note: This is the best book on fundamentals of
clinical trials to date. It is a must-read for a behavioral clinical trialist who follows
a progressive translational model, pushes toward a Phase III efcacy trial, and
wants a rm foundation in clinical trials fundamentals.]
George TC (2016) Investigator initiated trials (IITs) simplied. A practical
guide for clinical trial investigators to conduct IITs. Sunshine Press, Edison
This book is designed to serve as a guide for the clinical trial investigator who is
willing to initiate a trial on their own. The chapters include basics of IITs, regula-
tion, association with industry, protocol design, budget preparation, case report
forms, informed consent, reporting, clinical trial registration, conduct, monitoring,
and data management. [Author Note: This book focuses on the operational side of
clinical trials.]
Rosenberger WF, Lachin JM (2016) Randomization in clinical trials. Theory
and practice, 2nd edn. Wiley, Hoboken
This is a go-to guide for biostatisticians that features a unique combination of the
applied aspects of randomization in clinical trials with a nonparametric approach to
inference. [Author Note: This is everything you wanted to know about random
assignment.]
Shih WJ, Aisner J (2016) Statistical design and analysis of clinical trials: prin-
ciples and methods. Chapman & Hall/CRC, Boca Raton
This book concentrates on the biostatistics component of clinical trials. Developed
from the authors’ courses taught to public health and medical students, residents,
and fellows during the past 15years, the text shows how biostatistics in clinical tri-
als is an integration of many fundamental scientic principles and statistical meth-
ods. [Author Note: Drawing on extensive teaching experience, this book makes
statistical analyses of clinical trials easy and accessible.]
Appendix: Books onClinical Trials
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292
Wassmer G, Brannath W (2016) Group sequential and conrmatory adaptive
designs in clinical trials. Springer International, Switzerland
This book provides a review of the general principles of, and techniques for, conr-
matory adaptive designs. In these designs, interim analyses are performed with con-
trol for the type I error rate and a data-driven change in aspects of the design at
interim stages is permitted, including sample-size reassessment, treatment arm
selection, and selection of a prespecied population. Adaptive design methodology
is introduced at an elementary level and is appropriate for applied statisticians with
a sound statistical background. [Author Note: The focus of this book is on the mean-
ing of an adaptive design for a clinical trial in the statistical literature.]
Pfeiffer J, Wells C (2017) A practical guide to managing clinical trials. CRC
Press, Boca Raton
This is a basic, comprehensive guide to the operational side of clinical trials. This
user-friendly reference guides the reader through each step of the clinical trial pro-
cess from site selection to site setup, subject recruitment, trial visits, and trial 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 and FDA
regulations, and good clinical practices. [Author Note: This excellent book is
focused on trial operations and will be of considerable value to research staff.]
Piantadosi S (2017) Clinical trials: a methodologic perspective, 3rd edn.
Wiley, Hoboken
This is a straightforward, detailed, and authoritative presentation of quantitative
methods for clinical trials. Readers will encounter the principles of design for vari-
ous types of clinical trials and are then guided through the complete process of
planning the experiment, assembling a study cohort, assessing data, and reporting
results. Throughout the process, readers are alerted to the problems that may arise
and are offered common sense solutions. [Author Note: This book is written by one
of the world’s leading experts in the design and analysis of clinical trials in cancer.]
Rauch G, Schüler S, Kieser M (2017) Planning and analyzing clinical trials
with composite endpoints. Springer, NewYork
This book addresses the planning and evaluation of clinical trials with composite
primary endpoints so that clinically meaningful and valid interpretations result.
Composite endpoints combine several variables of interest within a single compos-
ite measure and, as a result, all variables that are of major clinical relevance can be
considered in the primary analysis without the need to adjust for multiplicity.
Composite endpoints can increase the size of the expected effects thus making clini-
cal trials more powerful. [Author Note: This book provides details on the pros and
cons of using composite endpoints to maximize efciency without losing clinical or
statistical signicance.]
Appendix: Books onClinical Trials
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293
National Academies of Sciences, Engineering, and Medicine (2019) Virtual
clinical trials: challenges and opportunities: Proceedings of a workshop.
National Academies Press, Washington, DC
The current model for clinical trials is outdated, inefcient, and costly. Clinical tri-
als are limited by small sample sizes that do not reect diversity, nancial burdens
on participants, slow processes, and, as a result, disconnect between research and
practice. This workshop was convened to explore benets and challenges to imple-
menting virtual clinical trials as an enhanced alternative for the future. [Author
Note: Virtual clinical trials are the wave of the future but are not without challenges.
This book presents the current state of the art and balances the opportunities against
the challenges.]
Pawlik TM, Sosa JA (2020) Clinical trials, 2nd edn. Springer, Cham
This is a comprehensive book on clinical trials covering history, ethics, design,
types of trials (pragmatic, cooperative, international), data handling, statistics, bud-
get, publishing, and patient-reported outcomes. The focus is on trials in surgery but
the topics reect recent developments in basic clinical trial methodology that apply
to a variety of outcomes. [Author Note: Surgical trials tend to be unblinded and, as
such, face challenges that are similar to those of behavioral trials. It is instructive to
see how similar challenges are being met across different disciplines.]
AppendixBooks onClinical Trials
https://t.me/medicina_free
295© Springer Nature Switzerland AG 2021
L. H. Powell et al., Behavioral Clinical Trials for Chronic Diseases,
https://doi.org/10.1007/978-3-030-39330-4
APPENDIX
Books onBehavioral Clinical Trials
These books represent the emerging literature on behavioral clinical trial methodol-
ogy. They are a reection of the relatively recent realization that trials testing behav-
ioral treatments face unique challenges seldom seen in double-blind drug trials.
Nezu AM, Nezu CM (2008) Evidence-based outcome research: a practical
guide to conducting randomized controlled trials for psychosocial interven-
tions. Oxford University Press, NewYork
This edited volume provides both conceptual and practical information for conduct-
ing and evaluating evidence-based outcome studies. It encompasses psychotherapy
research for traditional mental health disorders, such as depression and anxiety, and
psychosocial-based treatments provided to medical patients to inuence such dis-
ease processes as pain and cardiovascular risk or to improve quality of life. This is
a hands-on book with an emphasis on the practical nuts-and-bolts implementation
of psychosocial-based randomized trials from conception to completion. [Author
Note: This book emphasizes psychotherapy for mental health disorders and features
excellent chapters on treatment manuals, training therapists, and treatment delity.
Written by leading researchers and statisticians, chapters are organized around con-
ceptual, assessment, design, and data analysis issues.]
Torgerson DJ, Torgerson CJ (2008) Designing randomised trials in health, edu-
cation and the social sciences. An introduction. Palgrave Macmillan, NewYork
This book focuses on the design of rigorous trials rather than their statistical under-
pinnings. It features chapters on pragmatic designs, placebo controls, preference
designs, unequal allocation, economic evaluation, analytical approaches, and ran-
domization methods. [Author Note: This book provides an introduction to the
design of randomized trials in the social sciences. It features excellent descriptions
of factorial designs, cluster randomized designs, pragmatic trials, and explanatory
trials.]
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296
Boutron I, Ravaud P, Moher D (2012) Randomized clinical trials of nonphar-
macological treatments. Chapman & Hall/CRC, Boca Raton
Nonpharmacological treatments include a wide variety of treatments such as sur-
gery, technical procedures, implantable and non-implantable devices, rehabilitation,
psychotherapy, and behavioral interventions. Unlike pharmacological treatments,
these have no specic requirements for approval and consequently can be widely
proposed in clinical practice but inadequately evaluated. This situation is an impor-
tant barrier for the evaluation of the benecial effects of these treatments and the
conduct of clinical trials. This edited book focuses on the methods for assessing
nonpharmacological treatments, highlighting specic issues and trial designs.
[Author Note: Edited by leaders in the CONSORT collaboration, this book includes
excellent chapters on blinding, placebos, external validity, cluster randomized
designs, patient preference designs, and reporting guidelines.]
Areán PA, Kraemer HC (2013) High-quality psychotherapy research: From
conception to piloting to national trials. Oxford University Press, NewYork
Although psychotherapy research shares many of the same methodological issues
that pharmacology trials do, psychotherapy research poses unique challenges,
including the difculty of keeping participants blind to treatment assignment, the
need for a replicable treatment manual and therapist training procedure, the impor-
tance of outside observation of therapy quality ratings, and the problems research-
ers face in measuring the active ingredients of psychotherapy. Organized
developmentally, this book explains the conceptualization of the trial, the pilot
study, the large-scale study, and the multi-site trial. Topics include innovations in
data analysis, the operation of a multi-site psychotherapy trial, mediation of treat-
ment outcomes, translation to community practice, training community providers to
be study therapists, and recruiting hard-to-reach populations. This is a practical
book appropriate for a broad range of readers, from junior investigators developing
their rst study idea to seasoned investigators who wish to take their research to a
larger-scale level. [Author Note: This book is co-authored by a leader in behavioral
clinical trial methodology who has published extensively on methodological inno-
vation. The book is organized using a progressive translational model and features
excellent chapters on treatment manuals, interventionist training, and delity
assessment. Highly recommended for behavioral trialists with or without interests
in psychotherapy treatments.]
Appendix: Books onBehavioral Clinical Trials
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297
Tohen M, Bowden CL, Nierenberg AA, Geddess JR (2015) Clinical trial design
challenges in mood disorders. Academic Press, Cambridge
Poor clinical trial designs result in failed studies, wasted research funds, and limited
advancement of cures for disorders. This edited book outlines classic problems
researchers face in designing clinical trials for mood disorder treatments and dis-
cusses how to address them for the most denitive and generalizable results. Topics
include the placebo response, the generalizability of studies conducted in the devel-
oping world, maintenance studies, and the application of ndings to clinical prac-
tice. With international contributors from academia, industry, regulatory agencies,
and advocacy groups, this book will contribute to improved clinical trial design and
valid, precise, and reliable answers about what works better and faster for patients.
[Author Note: This book focuses on clinical trials for patients with mood and bipo-
lar disorders. It is a comprehensive description of the most problematic method-
ological issues that emerge when a treatment is aimed at alleviating mental health
disorders.]
Gitlin LN, Czaja SJ (2016) Behavioral intervention research. Designing, evalu-
ating, and implementing. Springer, NewYork
This unique text provides comprehensive coverage of one of the most neglected, yet
vitally important, areas of public health research: developing, evaluating, and imple-
menting novel behavioral interventions in service and practice settings. Written for
novice and expert researchers, this book examines the most critical issues needed to
successfully implement current and future evidence-based protocols in practice set-
tings. Topics include ways to develop and advance an intervention, hybrid trial
designs, theories and models for integrating behavioral interventions with imple-
mentation science, recruitment and retention strategies for diverse samples, research
designs for different stages of intervention development, treatment delity models
and measures, novel measurement and analytic strategies, cost analyses, selection
of control groups, use of mixed methodology, ethics and informed consent, technol-
ogy-based intervention approaches, and professional considerations. Abundant case
examples from successful national and international behavioral intervention trials
illustrate key concepts. [Author Note: This edited book focuses on the practical side
of designing and implementing behavioral clinical trials. It includes excellent chap-
ters on implementation/dissemination, grant writing, publishing, and the impor-
tance of assembling the right team.]
Appendix: Books onBehavioral Clinical Trials
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298
Robertson CT, Kesselheim AS (2016) Blinding as a solution to bias.
Strengthening biomedical science, forensic science, and law. Academic Press,
Cambridge
What information should jurors have during court proceedings to render a just deci-
sion? Should politicians know who is donating money to their campaigns? Will
scientists draw biased conclusions about drug efcacy when they know more about
the patient or study population? The potential for bias in decision-making by physi-
cians, lawyers, politicians, and scientists has been recognized for hundreds of years
and drawn attention from media and scholars seeking to understand the role that
conicts of interest and other psychological processes play. However, commonly
proposed solutions to biased decision-making, such as transparency (disclosing
conicts) or exclusion (avoiding conicts), do not directly solve the underlying
problem of bias and may have unintended consequences. [Author Note: Behavioral
clinical trials often preclude the ability to double-blind to treatments. This book is a
deep dive into blinding, the consequences that result when it is not protected, and its
central role in producing a conclusive result in a behavioral trial. It is recommended
for those with serious interests in pushing toward conrmatory behavioral clinical
trials.]
Leigh A (2018) Randomistas. How radical researchers changed our world. Yale
University Press, New Haven
Across medicine, business and government, there’s no simpler or more powerful
tool for nding out what works than a randomised experiment. Investigating every-
thing from jails to ad compaigns, philanthropy, teaching, and crime, the randomistas
build evidence and bust myths. Andrew Leigh is an economist who tells the stories
of the radical researchers who overturned conventional wisdom in medicine, poli-
tics, economics, and law enforcement. From nding the cure to scurvy to discover-
ing what policies really improve literacy rates, randomistas have shaped life as we
know it—but they often had to ght to conduct their trials and have their ndings
implemented. [Author Note: This book features an engaging set of stories about
how random assignment has led to the debunking of myths and discovery of truth.
It is fun to read and in the process produces an in-depth understanding of the value
of randomization: the sine qua non of clinical trials.]
AppendixBooks onBehavioral Clinical Trials
https://t.me/medicina_free
299© Springer Nature Switzerland AG 2021
L. H. Powell et al., Behavioral Clinical Trials for Chronic Diseases,
https://doi.org/10.1007/978-3-030-39330-4
APPENDIX
Chapter Reviewers
Walter Ambrosius, PhD
Department of Biostatistical Sciences
Division of Public Health Sciences
Wake Forest University Health Sciences
VINE, 4529
Medical Center Boulevard
Winston-Salem, NC 27157
Bradley Appelhans, PhD
Department of Preventive Medicine
Rush University Medical Center
1700W.Van Buren St., Suite 470
Chicago, IL 60612
Simon L.Bacon, PhD, FTOS, FCCS,
FABMR
Department of Health, Kinesiology, and
Applied Physiology
Concordia University
7141 Sherbrooke St. West, L-SP 165-35
Montreal, Quebec, H4B 1R6
Canada
Kelly Glazer Baron, PhD, MPH, DBSM
Division of Public Health
Department of Family and Preventive Medicine
University of Utah
Salt Lake City, UT 84132
Rogelio A.Coronado, PhD
Department of Orthopaedic Surgery and
Rehabilitation
Vanderbilt University Medical Center
Nashville, TN 37232
Melissa Crane, PhD
Department of Preventive Medicine
Rush University Medical Center
1700W.Van Buren St., Suite 470
Chicago, IL 60612
Susan M.Czajkowski, PhD
Health Behaviors Research Branch
Behavioral Research Program
Division of Cancer Control
and Population Sciences
National Cancer Institute
National Institutes of Health
9609 Medical Center Drive
BG 9609 MSC 9760
Bethesda, MD 20892
Bradley Efron, PhD
Department of Statistics
390 Serra Mall
Stanford University
Stanford, CA 94305
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