Designing Clinical Research THIRD EDITION

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Clinical Research,THIRD EDITION,STEPHEN B HULLEY M D M P H. Professor and Chair Department of Epidemiology Biostatistics. Director Clinical and Translational Sciences Training Program. University of California San Francisco,STEVEN R CUMMINGS M D. Founding Director San Francisco Coordinating Center. Senior Scientist California Pacific Medical Center Research Institute. Professor Emeritus University of California San Francisco. WARREN S BROWNER M D M P H,Scientific Director Research Institute. Vice President Academic Affairs,California Pacific Medical Center. Adjunct Professor University of California San Francisco. DEBORAH G GRADY M D M P H, Professor of Epidemiology Biostatistics and of Medicine.
Director Women s Health Clinical Research Center, Associate Dean for Clinical Translational Research. University of California San Francisco,THOMAS B NEWMAN M D M P H. Professor of Epidemiology Biostatistics and of Pediatrics. Chief Division of Clinical Epidemiology,Attending Physician Department of Pediatrics. University of California San Francisco,Acquisitions Editor Sonya Seigafuse. Managing Editor Nancy Winter,Project Manager Jennifer Harper.
Manufacturing Coordinator Kathleen Brown,Marketing Manager Kimberly Schonberger. Designer Stephen Druding, Production Services Laserwords Private Limited Chennai India. Printer Data Reproductions Corporation, 2007 by LIPPINCOTT WILLIAMS WILKINS a Wolters Kluwer business. 530 Walnut Street,Philadelphia PA 19106 USA,1998 Williams Wilkins. 2001 Lippincott Williams Wilkins, All rights reserved This book is protected by copyright No part of this book may be reproduced in any.
form or by any means including photocopying or utilized by any information storage and retrieval system. without written permission from the copyright owner except for brief quotations embodied in critical articles. and reviews Materials appearing in this book prepared by individuals as part of their official duties as U S. government employees are not covered by the above mentioned copyright. Printed in the USA, Library of Congress Cataloging in Publication Data. Designing clinical research by Stephen B Hulley et al 3rd ed. Includes bibliographical references and index,ISBN 13 978 0 7817 8210 4. ISBN 10 0 7817 8210 4,1 Clinical trials 2 Medicine Research Methodology. 3 Epidemiology Research Methodology I Hulley Stephen B. DNLM 1 Epidemiologic Methods 2 Research Design WA 950 D457 2007. R853 C55D47 2007,610 72 dc22 2006028271, Care has been taken to confirm the accuracy of the information presented and to describe generally. accepted practices However the authors editors and publisher are not responsible for errors or omissions or. for any consequences from application of the information in this book and make no warranty expressed or. implied with respect to the currency completeness or accuracy of the contents of the publication Application. of this information in a particular situation remains the professional responsibility of the practitioner. The authors editors and publisher have exerted every effort to ensure that drug selection and dosage set. forth in this text are in accordance with current recommendations and practice at the time of publication. However in view of ongoing research changes in government regulations and the constant flow of. information relating to drug therapy and drug reactions the reader is urged to check the package insert for. each drug for any change in indications and dosage and for added warnings and precautions This is. particularly important when the recommended agent is a new or infrequently employed drug. Some drugs and medical devices presented in this publication have Food and Drug Administration. FDA clearance for limited use in restricted research settings It is the responsibility of the health care. provider to ascertain the FDA status of each drug or device planned for use in their clinical practice. To purchase additional copies of this book call our customer service department at 800 638 3030 or. fax orders to 301 223 2320 International customers should call 301 223 2300. Visit Lippincott Williams Wilkins on the Internet at LWW com Lippincott Williams Wilkins. customer service representatives are available from 8 30 am to 6 pm EST. 10 9 8 7 6 5 4 3 2 1,To our families and our students.
Contributing Authors xi,Introduction xiii,Acknowledgments xv. Section I Basic Ingredients,1 Getting Started The Anatomy and. Physiology of Clinical Research 3,Anatomy of Research What It s Made Of 3. Physiology of Research How It Works 8,Designing the Study 13. Summary 14,Appendix 1 1 Outline of a Study 15,Reference 15.
2 Conceiving the Research Question 17,Origins of a Research Question 18. Characteristics of a Good Research Question 19, Developing the Research Question and Study Plan 22. Translational Research 23,Summary 25,References 25. 3 Choosing the Study Subjects Specification Sampling. and Recruitment 27,Basic Terms and Concepts 28,Selection Criteria 29. Sampling 32,Recruitment 33,Summary 35, Appendix 3 1 Selecting a Random Sample from a Table of Random Numbers 36.
References 36,vi Contents, 4 Planning the Measurements Precision and Accuracy 37. Measurement Scales 38,Precision 39,Accuracy 41,Other Features of Measurement Approaches 45. Measurements on Stored Materials 46,In Closing 47,Summary 47. Appendix 4 1 Operations Manual Operational Definition of a Measurement of Grip. Strength 48,References 49, 5 Getting Ready to Estimate Sample Size Hypotheses. and Underlying Principles 51,Hypotheses 51,Underlying Statistical Principles 54.
Additional Points 59,Summary 62,References 63,6 Estimating Sample Size and Power Applications. and Examples 65, Sample Size Techniques for Analytic Studies and Experiments 65. Other Considerations and Special Issues 71,Sample Size Techniques for Descriptive Studies 73. What to do When Sample Size is Fixed 75, Strategies for Minimizing Sample Size and Maximizing Power 76. How to Estimate Sample Size When there is Insufficient Information 81. Common Errors to Avoid 82,Summary 83, Appendix 6A Sample Size Required per Group When Using the t Test.
to Compare Means of Continuous Variables 84, Appendix 6B Sample Size Required per Group When Using the Chi Squared. Statistic or Z Test to Compare Proportions of Dichotomous Variables 86. Appendix 6C Total Sample Size Required When Using the Correlation. Coefficient r 89, Appendix 6D Sample Size for a Descriptive Study of a Continuous. Variable 90, Appendix 6E Sample Size for a Descriptive Study of a Dichotomous. Variable 91,Appendix 6F Use and Misuse of t Tests 92. References 93,Contents vii,Section II Study Designs.
7 Designing a Cohort Study 97,Prospective Cohort Studies 97. Retrospective Cohort Studies 99,Nested Case Control and Case Cohort Studies 100. Multiple Cohort Studies and External Controls 103,Other Cohort Study Issues 104. Summary 106,References 106, 8 Designing Cross Sectional and Case Control Studies 109. Cross Sectional Studies 109,Case Control Studies 112.
Choosing Among Observational Designs 121,Summary 121. Appendix 8A Calculating Measures of Association 122. Appendix 8B Why the Odds Ratio Can Be Used as an Estimate for Relative Risk. in a Case Control Study 123,References 125, 9 Enhancing Causal Inference in Observational Studies 127. Spurious Associations 127,Real Associations Other than Cause Effect 131. Coping With Confounders in the Design Phase 132,Coping with Confounders in the Analysis Phase 137. Underestimation of Causal Effects 141,Choosing a Strategy 141.
Summary 143, Appendix 9A Hypothetical Example of Confounding and Interaction 144. Appendix 9B A Simplified Example of Adjustment 145. References 146,10 Designing a Randomized Blinded Trial 147. Selecting the Intervention and Control Conditions 147. Choosing Outcome Measurements 150,Selecting the Participants 152. Measuring Baseline Variables 154,Randomizing and Blinding 155. Summary 159,References 160,viii Contents, 11 Alternative Trial Designs and Implementation Issues 163.
Alternative Clinical Trial Designs 163,Conducting a Clinical Trial 170. Summary 179, Appendix 11 1 Interim Monitoring of Trial Outcomes 180. References 181,12 Designing Studies of Medical Tests 183. Determining Whether a Test is Useful 183,Studies of Test Reproducibility 186. Studies of the Accuracy of Tests 188, Studies of the Effect of Test Results on Clinical Decisions 192.
Studies of Feasibility Costs and Risks of Tests 193. Studies of the Effect of Testing on Outcomes 194, Pitfalls in the Design or Analysis of Diagnostic Test Studies 196. Summary 199, Appendix 12A Calculation of Kappa to Measure Interobserver Agreement 200. Appendix 12B Numerical Example of Verification Bias 1 202. Appendix 12C Numerical Example of Verification Bias 2 203. References 204,13 Utilizing Existing Databases 207. Advantages and Disadvantages 207,Secondary Data Analysis 208. Ancillary Studies 211,Systematic Reviews 213,Summary 218.
Appendix 13 1 Statistical Methods for Meta Analysis 219. References 220,Section III Implementation,14 Addressing Ethical Issues 225. Ethical Principles 225, Federal Regulations for Research on Human Subjects 226. Research Participants who Require Additional Protections 231. Responsibilities of Investigators 232, Ethical Issues Specific to Certain Types of Research 235. Other Issues 236,Contents ix,Summary 237,References 237. 15 Designing Questionnaires and Interviews 241,Designing Good Instruments 241.
Steps in Assembling the Instruments for the Study 250. Administering the Instruments 252,Summary 253, Appendix 15 1 An Example of a Questionnaire about Smoking 254. References 255,16 Data Management 257,Data Tables 257. Data Entry 261,Extracting Data Queries 266,Identifying and Correcting Errors in the Data 267. Analysis of the Data 268,Confidentiality and Security 268. Summary 269,References 269,17 Implementing the Study and Quality Control 271.
Assembling Resources 272,Finalizing the Protocol 276. Quality Control During the Study 279,Summary 286, Appendix 17 1 Example of an Operations Manual Table of Contents 286. Appendix 17 2 Quality Control Tables and Checklists 287. References 289,18 Community and International Studies 291. Why Community and International Research 291,Community Research 293. International Research 294,Summary 299,References 299.
19 Writing and Funding a Research Proposal 301,Writing Proposals 301. Elements of a Proposal 303,Characteristics of Good Proposals 309. x Contents,Finding Support for Research 310,Summary 315. References 316,Exercises 317,Answers 331,Subject Index 353. CONTRIBUTING AUTHORS,Norman Hearst M D M P H, Professor of Family Community Medicine and of Epidemiology Biostatistics.
Attending Physician Department of Family and Community Medicine. University of California San Francisco,Michael A Kohn M D M P P. Associate Clinical Professor of Epidemiology Biostatistics. Director Data Management Consulting Services,Clinical Translational Sciences Institute. University of California San Francisco,Bernard Lo M D. Professor and Director Program in Medical Ethics, Attending Physician Department of Medicine UCSF Medical Center. University of California San Francisco,Jeffrey N Martin M D M P H.
Associate Professor of Epidemiology Biostatistics and of Medicine. Director Training In Clinical Research Program, Attending Physician Department of Medicine San Francisco General Hospital. University of California San Francisco,Thomas E Novotny M D M P H. Professor in Residence Epidemiology Biostatistics, Director International Programs School of Medicine. University of California San Francisco,INTRODUCTION. This book is about the science of doing clinical research in all its forms translational. research clinical trials patient oriented research epidemiologic studies behavioral. science and health services research Codifying the nature of this broad based science. and how to do it is not straightforward and there is no single approach that everyone. agrees is best Our first two editions drew on the terms and principles of epidemiology. in a practical and reader friendly way emphasizing systematic and common sense. approaches to the many judgments involved in designing a study. The Third Edition of Designing Clinical Research DCR follows the same. path adding new developments along the way New material on observational. studies includes case crossover designs and the use of propensity scores instrumental. variables and Mendelian randomization to control confounding Reorganized chapters. on clinical trials introduce adaptive designs and those on studying medical tests and on. utilizing existing datasets present expanded options that will be attractive to beginning. investigators The chapter on research ethics is extensively updated the one on data. management entirely new reflecting current approaches to information technology. and a rewritten chapter on study implementation and quality control introduces. practicalities of study startup and regulatory issues Good Clinical Practices An. Designing Clinical Research THIRD EDITION STEPHEN B HULLEY M D M P H Professor and Chair Department of Epidemiology amp Biostatistics Director Clinical and Translational Sciences Training Program University of California San Francisco STEVEN R CUMMINGS M D Founding Director San Francisco Coordinating Center

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