Table Of ContentHealth Informatics
(formerly Computers in Health Care)
Kathryn J. Hannah Marion J. Ball
Series Editors
Springer Science+Business Media, LLC
Health Informatics Series
(formerly Computers in Health Care)
Series Editors
Kathryn J. Hannah Marion J. Ball
Dental Informatics
Integrating Technology into the Dental Environment
L.M. Abbey and J. Zimmerman
Aspects of the Computer-based Patient Record
MJ. Ball and M.F. Collen
Performance Improvement Through Information Management
Health Care's Bridge to Success
M.J. Ball and J.V. Douglas
Strategies and Technologies for Healthcare Information
Theory into Practice
M.J. Ball, J.V. Douglas, and D.E. Garets
Nursing Informatics
H1zere Caring and Technology Meet, Third Edition
MJ. Ball, K.J. Hannah, S.K. Newbold, and LV. Douglas
Healthcare Information Management Systems
A Practical Guide, Second Edition
M.J. Ball, D.W. Simborg, J.W. Albright, andJ.V. Douglas
Clinical Decision Support Systems
Theory and Practice
E.S. Berner
Strategy and Architecture of Health Care Information Systems
M.K. Bourke
Information Networks for Community Health
P.F. Brennan, S.L Schneider, and E. Tornquist
Introduction to Clinical Informatics
P. Degoulet and M. Fieschi
Patient Care Information Systems
Successful Design and Implementation
E.L. Drazen, J.B. Metzger, J.L. Ritter, and M.K. Schneider
Introduction to Nursing Informatics, Second Edition
KJ. Hannah, M.J. Ball, and MJ.A. Edwards
Information Technology for the Practicing Physician
J.M. Kiel
(continued after Index)
John S. Silva Marion J. Ball
Christopher G. Chute Judith V. Douglas
Curtis P. Langlotz Joyce C. Niland
William L. Scherlis
Editors
Cancer Informatics
Essential Technologies
for Clinical Trials
With a Foreword by Richard D. Klausner
With 62 Illustrations
, Springer
John S. Silva, MD Marion J. Ball, EdD Christopher G. Chute, MD, DrPH
Center for Bioinfonnatics Vice President, Clinical Solutions Professor of Medical Infonnatics
National Cancer Institute Healthlink, Inc. Head, Section of Medical
E1dersburg, MD 21784, USA Adjunct Professor Infonnation Resources
[email protected] Johns Hopkins University School Mayo Clinic
of Nursing Rochester, MN 55905, USA
Baltimore, MD 21210, USA [email protected]
Judith V. Douglas, MA, MHS
[email protected]
Adjunct Faculty
Joyce C. Niland, PhD
Johns Hopkins University
Curtis P. Langlotz, MD, PhD Chair, Division of Infonnation
School of Nursing
Assistant Professor of Radiology, Sciences
Reisterstown, MD 21136, USA
Epidemiology, and Computer Director, Department of Biostatistics
[email protected]
and Infonnation Science City ofHope National Medical Center
Formerly Associate,
University of Pennsylvania Duarte, CA 91010, USA
First Consulting Group
Moorestown, NJ 08057, USA [email protected]
Faculty of Medicine
[email protected]
Baltimore, MD 21210, USA
Marion J. BaII, EdD
Series Editors: Vice President, Clinical Solutions
William L. Scherlis, PhD Kathryn J. Hannah, PhD, RN Healthlink, Inc.
Principal Research Scientist Professor, Department of Adjunct Professor
School of Computer Science Community Health Science Johns Hopkins University School
Carnegie Mellon University The University of Calgary of Nursing
Pittsburgh, PA 15213, USA Calgary, Alberta, Canada Baltimore, MD 21210, USA
[email protected] [email protected] [email protected]
Library of Congress Cataloging-in-Publication Data
Cancer infonnatics: essential technologies for c1inical trials/editors, John S. Silva [et al.].
p.; cm. - (Health infonnatics)
Includes bibliographical references and index.
ISBN 978-1-4612-6547-4 ISBN 978-1-4613-0063-2 (eBook)
DOI 10.1007/978-1-4613-0063-2
1. Cancer-Research. 2. Clinical trials. 3. Medical infonnatics. 1. Silva, John S. II. Series.
[DNLM: 1. Neoplasms. 2. Clinical Trials-methods. 3. Medical Infonnatics. QZ 26.5 C215 2002]
RC267 .C363 2002
616.99'~c21
Printed on acid-free paper. 2001040097
© 2002 Springer Science+Business Media New York
Originally published by Springer-Verlag New York, Inc in 2002
Softcover reprint of the hardcover l st edition 2002
AII rights reserved. This work may not be translated or copied in whole or in part without the writlen permission of
the publisher Springer Science+Business Media, LLC except for brief excerpts in connection with reviews or scholarly
analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software,
or by similar or dissimilar methodology now known or hereafter developed is forbidden.
The USe of general descriptive names, trade names, trademarks, etc., in this publication, eVen if the former are not
especially identified, is not to be taken as a sign that such names, as understood by the Trade Marks and Merchandise
Marks Act, may accordingly be used freely by anyone.
While the advice and information in this book are believed to be true and accurate at the date of going to press,
neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions
that may be made. The publisher makes no warranty, express or implied, with respect to the material contained
herein.
Production coordinated by Chemow Editorial' Services, Inc., and managed by Tim Taylor; manufacturing
supervised by Joe Quatela.
Typeset by SPS Publishing Service (P) Ltd., Madras, India.
9 8 7 6 5 432 I
ISBN 978-1-4612-6547-4
Dedication
Here is a book dedicated to people who have experience with cancer, those who
will benefit from the creation of a Cancer Informatics Infrastructure.
This book is the first to set forth this vision. To do so, it brings together a
constellation of contributors who describe how information technology can
improve clinical trials. It culls information from top institutions, associations,
journals, and projects to explain how this informatics infrastructure can help
translate cancer research into cancer care and control.
As this vision becomes real, it will accelerate knowledge about cancer, its
causes, and its treatment, paralleling the creation by the National Library of
Medicine, NIH, of the Clinical Trials Database, www.clinicaltrials.gov. Like
that database, the Cancer Informatics Infrastructure reaches beyond basic
science and its investigators to physicians and to patients, offering them
resources that apply to each individual situation with its specific personal
challenges.
Today, clinicaltrials.gov is an answer to the dilemma of what is the newest,
most hopeful, available clinical trial and how to get into it. Tomorrow, the
Cancer Informatics Infrastructure will join it in applying information technology
to science and clinical medicine and making knowledge available to all.
Tenley E. Albright, MD
Harvard Medical School
Whitehead Biomedical Research Institute
Former Chairman, Board of Regents, National Library of Medicine
v
Foreword
It has become de rigueur to pronounce this the age of informatics in medicine
and biology. Of course, at some level, this is a reflection of the larger
information age that pervades so much of modem society. Despite the new
automaticity of this claim, the pronouncement speaks the truth. Yet, in medicine
and biology, the age of informatics is not a statement about the current reality
but rather a vision of where we must go.
The transformation of biology, or rather of biologic research, from an
experimental to an experimental plus information science is deep and profound.
It reflects not just a new approach to doing research (although that too is
happening) but a fundamental evolution in how biologic questions are asked,
how data are acquired and analyzed, and how we begin to grapple with both the
daunting complexity of biology and its enormous and essential variability.
Biologic research is asking and answering questions about living systems and
life processes. That information lay at the core of biology is not new but rather
directly reflects the great biologic revolution of the mid-twentieth century with
the discovery of the structure of DNA, the genetic code, and the emergence of
molecular genetics/molecular biology. With these developments, biology
fundamentally became the study of the storage, transmission, and decoding of
information, on the one hand, and the function and structures of the decoded
information products, on the other hand. It is interesting, and not coincidental,
that a qualitative change in the approach to biology as an information intense
science comes at the same time that the rest of society is entering the
information age. The capacity to cope with, analyze, exchange, and communi
cate large amounts of information and the wide dissemination of that capacity in
biology is a reflection of the same microprocessor revolution that has enabled
the broader information age. The human genome project, genomics, and the
proliferation of other "-omics" are all possible because of high capacity
computing. Equally important, the dissemination of these changes to the broad
scientific community was made possible by the distribution of computers,
networking and a sociology of computer literacy/familiarity within the biologic
research community. High-throughput analyses of biologic systems are
producing data sets of extremely high dimensionality. A growing collection of
vii
viii Foreword
measurement tools, more extensive laboratory and imaging data acquisition, and
an emerging domain of inquiry (including organ and organismal biology,
genetic variation, polygenic traits, structural biology, population science), and a
growing acceptance of the possible role of computational modeling as of real
value to biology are all ushering in the need to marry biology with
computational and information sciences.
On the other end of the biology-medicine spectrum is the recognition of the
role of information sciences in clinical medicine. This is driven by three factors.
First are the administrative demands for more efficient and accurate "business"
systems for medical records, pharmacy, laboratory, and special studies, as well
as billing, quality control, and, when applicable, reporting requirements. Second
is the need to access a growing amount of information in all aspects of medicine.
Third is the need to provide that information to multiple users and to couple its
accessibility with the ability to communicate.
About four years ago in a speech to the American Society of Clinical
Oncology, I proposed the need for a Cancer Informatics Infrastructure (CII) to
enable the cancer research enterprise and to link it to the delivery of cancer care.
I envisioned this as a difficult but essential undertaking for the National Cancer
Institute (NCI). The goal was to develop a process and commit the resources for
the creation of an enabling architecture, a set of standards, a means of
dissemination and training, and, when appropriate, the development, adoption,
and modification of tools and applications. Although these issues needed to be
addressed for all aspects of the National Cancer Research Program, we felt
we should tum to clinical trials as the centerpiece and starting point for the
CII.
Why Clinical Trials?
First, clinical trials represent the crucible through which the insights, ideas, and
tools of basic science and technology meet clinical practice through the testing
of hypotheses in human beings and the garnering of evidence that will drive the
changing behavior of the medical and public health systems. If we were to begin
to meaningfully ask precise, detailed, and intelligent questions about biology,
pharmacology, physiology and pathology in human beings, the crucible of the
clinical trial needs to be up to the task; this would require the capacity to ask and
answer these increasingly complex questions and to monitor states that would be
rich and complex in information content. Furthermore, if we were going to be
able to develop meaningfully the interfaces between the description of clinical
states, molecular pathology, complex imaging data, genetics, and chemistry to
create scientifically intense clinical trials, common language and compatible
data sets would be essential.
Second, clinical trials, especially multi-site clinical trials, have always been
enterprises that could only work if standards were established and applied and if
data from disparate sites could be reliably merged.
Foreword ix
Third, we recognized the need to re-evaluate the actual functioning of the
clinical trials system to achieve a number of goals:
1. The design, implementation, monitoring, and reporting of clinical trials had
to become more efficient and less administratively burdensome.
2. We needed to move towards a truly national system, in which access to
available clinical trials was made broader and more facile for physicians and
patients.
3. We needed to smoothly link the clinical trials system to an open, accessible
information and communication system available to physicians, patients,
healthcare organizations, sponsors, and funders.
Clearly, none of these goals could be achieved without an information system
through which clinical trials could be designed, executed, analyzed, and
reported.
With these considerations, we embarked on a program to begin to create a CII
for cancer clinical trials. We recognized multiple challenges:
1. Strategic Vision. We needed to articulate an overall set of concepts about
the models upon which the CII would be built, the principles underlying
those models, the nature of the system architecture, and the scope and
definition of standards.
2. Tactical Approach. We needed next to define the planning, oversight, and
implementation processes. These included critical technical decisions and
establishing affordable budgets. Decisions had to be made about the order of
development, how to deal with legacy systems, what to specify and what not
to specify, what to develop or adopt, and what to adapt, purchase, or leave to
users to solve. We needed to establish how the CII would integrate with
other standard developers, both conceptually and technically.
3. Sociologic Issues. The success or failure of the CII will rest not only with
these strategic and tactical decisions or even with the products per se. Rather
it will succeed or fail with the users. Only an approach that would satisfy
their needs and be perceived and experienced as satisfying these needs and
as being of benefit could be adopted. This would require buy-in from the
beginning, ongoing input, usability-based development, and a realistic plan
for dissemination, distribution, and adoption.
There is no question that the only way we will fully realize the potential of
cancer research is to develop better tools for acquiring, analyzing, sharing, and
communicating data and for being sure that we optimize how data are turned
into meaningful information. This volume, many of whose contributors are
actively engaged in the realization of the concept of a Cancer Informatics
Infrastructure, describes current thinking about how such an infrastructure might
be constructed. It is hard to produce a book in areas such as informatics and
clinical trials that will remain relevant in the face of rapidly changing
x Foreword
technologies, evolving policy issues, and ever-expanding expectations. Despite
that challenge, this volume lays out principles and processes that are of interest
and value and will remain relevant for some time to come.
Richard D. Klausner, MD
Director, National Cancer Institute
Series Preface
This series is directed to healthcare professionals who are leading the
transformation of health care by using information and knowledge. Launched
in 1988 as Computers in Health Care, the series offers a broad range of titles:
some addressed to specific professions such as nursing, medicine, and health
administration; others to special areas of practice such as trauma and radiology.
Still other books in the series focus on interdisciplinary issues, such as the
computer-based patient record, electronic health records, and networked
healthcare systems.
Renamed Health Informatics in 1998 to reflect the rapid evolution in the
discipline now known as health informatics, the series will continue to add titles
that contribute to the evolution of the field. In the series, eminent experts,
serving as editors or authors, offer their accounts of innovations in health
informatics. Increasingly, these accounts go beyond hardware and software to
address the role of information in influencing the transformation of healthcare
delivery systems around the world. The series also will increasingly focus on
"peopleware" and the organizational, behavioral, and societal changes that
accompany the diffusion of information technology in health services
environments.
These changes will shape health services in the new millennium. By making
full and creative use of the technology to tame data and to transform
information, health informatics will foster the development of the knowledge
age in health care. As coeditors, we pledge to support our professional
colleagues and the series readers as they share advances in the emerging and
exciting field of health informatics.
Kathryn 1. Hannah, PhD, RN
Marion 1. Ball, EdD
Xl
