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Cancer Informatics: Essential Technologies for Clinical Trials PDF

395 Pages·2002·7.412 MB·English
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Health 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

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