A Managers’ Guide to the Design and Conduct of Clinical Trials, 2nd Edition临床实验设计与实施管理人员指南 第2版 txt umd azw3 下载 fb2 pdf 在线 免费

　　This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.

Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.

This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-includethe following material:

·Should the trials be conducted?

·Put it in the computer and keep it there

·Staffing for success

·Designing trials and determining sample size

·Budgeting

·Recruiting and retaining patients and physicians

·Data management

·Monitoring the trials

·Data analysis

·After action review

·Exception handling

Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource.

1. Cut Costs and Increase Profits.

　No Excuse for the Wastage.

　Front-Loaded Solution.

　Downsizing.

　Think Transnational.

　A Final Word.

2. Guidelines.

　Start with Your Reports.

　The Wrong Way.

　Keep It in the Computer.

　Don’t Push the River.

　KISS.

　Plug the Holes as They Arise.

　Pay for Results, Not Intentions.

　Plan, Do, Then Check.

PART I PLAN.

　3. Prescription for Success.

　　Plan.

　　　A. Predesign Phase.

　　　B. Design the Trials.

　　Do.

　　　C. Obtain Regulatory Agency Approval for the Trials.

　　　D. Form the Implementation Team.

　　　E. Line Up Your Panel of Physicians.

　　　F. Develop the Data Entry Software.

　　　G. Test the Software.

　　　H. Train.

　　　I. Recruit Patients.

　　　J. Set Up External Review Committees.

　　　K. Conduct the Trials.

　　　L. Develop Suite of Programs for Use in Data Analysis.

　　　M. Analyze and Interpret the Data.

　　Check.

　　　N. Complete the Submission.

　4. Staffing for Success.

　　The People You Need.

　　　Design Team.

　　　Obtain Regulatory Approval for the Trials.

　　　Track Progress.

　　　Implementation Team.

　　　Develop Data Entry Software.

　　　Test the Software.

　　　Line Up Your Panel of Physicians.

　　　External Laboratories.

　　　Site Coordinators.

　　　External Review Committees.

　　　Recruit and Enroll Patients.

　　　Transnational Trials.

　　　Conduct the Trials.

　　　Programs for Data Analysis.

　　　Analyze and Interpret the Data.

　　The People You Don’t Need.

　　For Further Information.

　5. Design Decisions.

　　Should the Study Be Performed?

　　Should the Trials Be Transnational?

　　Study Objectives.

　　End Points.

　　　Secondary End Points.

　　　Should We Proceed with a Full-Scale Trial?

　　　Tertiary End Points.

　　　Baseline Data.

　　　Who Will Collect the Data?

　　Quality Control.

　　Study Population.

　　Timing.

　　Closure.

　　　Planned Closure.

　　　Unplanned Closure.

　　Be Defensive. Review, Rewrite, Review Again.

　　Checklist for Design.

　　Budgets and Expenditures.

　　For Further Information.

　6. Trial Design.

　7. Exception Handling.

PART II DO

　8. Documentation.

　9. Recruiting and Retaining Patients and Physicians.

　10. Computer-Assisted Data Entry.

　11. Data Management.

　12. Are You Ready?

　13. Monitoring the Trials.

　14. Managing the Trials.

　15. Data Analysis.

PART III CHECK.

　16. Check.

Appendix Software.

Author Index.

Subject Index.

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作者简介：

Phillip Good, Ph.D., a graduate of UC Berkeley's statistics program, is the author of sixteen published books. He has 23 years of experience in the pharmaceutical and medical device industries, first with Upjohn, and then as an independent consultant. He has taught anatomy and biology, and has also served as Calloway Professor of Computer Science at the University of Georgia at Fort Valley. Dr. Good has lectured extensively throughout the world, including an appointment as traveling lecturer for the American Statistical Association.

书籍介绍

This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.

Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.

This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-includethe following material:

* Should the trials be conducted?

* Put it in the computer and keep it there

* Staffing for success

* Designing trials and determining sample size

* Budgeting

* Recruiting and retaining patients and physicians

* Data management

* Monitoring the trials

* Data analysis

* After action review

* Exception handling

Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource.

Praise for the First Edition:

". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ."

-Statistics in Medicine

"The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." -Technometrics

"This book is must-have reading for anyone in the business . . ."

-Clinical Chemistry