A Manager’s Guide to the Design and Conduct of Clinical Trials 2nd Edition by Phillip I Good ISBN 0471788708 978-0471788706
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ISBN 10:0471788708
ISBN 13:978-0471788706
Author:Phillip I.Good
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
Table of contents:
- Cut Costs and Increase Profits
No Excuse for the Wastage
Front-Loaded Solution
Downsizing
Think Transnational
A Final Word - 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
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 - 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 - 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 - Trial Design
Baseline Measurements
Controlled Randomized Clinical Trials
Randomized Trials
Blocked Randomization
Stratified Randomization
Single- vs. Double-Blind Studies
Allocation Concealment
Exceptions to the Rule
Sample Size
Which Formula?
Precision of Estimates
Bounding Type I and Type II Errors
Equivalence
Software
Subsamples
Loss Adjustment
Number of Treatment Sites
Alternate Designs
Taking Cost into Consideration
For Further Information - Exception Handling
Patient Related
Missed Doses
Missed Appointments
Noncompliance
Adverse Reactions
Reporting Adverse Events
When Do You Crack the Code?
Investigator Related
Lagging Recruitment
Protocol Deviations
Site-Specific Problems
Closure
Intent to Treat
Is Your Planning Complete? - Part II Do
Documentation
Guidelines
Common Technical Document
Reporting Adverse Events
Initial Submission to the Regulatory Agency
Sponsor Data
Justifying the Study
Objectives
Patient Selection
Treatment Plan
Outcome Measures and Evaluation
Procedures
Clinical Follow-Up
Adverse Events
Data Management, Monitoring, Quality Control
Statistical Analysis
Investigator Responsibilities
Ethical and Regulatory Considerations
Study Committees
Appendixes
Sample Informed Consent Form
Procedures Manuals
Physician’s Procedures Manual
Laboratory Guidelines
Interim Reports
Enrollment Report
Data in Hand
Adverse Event Report
Annotated Abstract
Final Reports(s)
Regulatory Agency Submissions
e-Subs
Journal Articles
For Further Information - Recruiting and Retaining Patients and Physicians
Selecting Your Clinical Sites
Recruiting Physicians
Teaching Hospitals
Clinical Resource Centers
Look to Motivations
Physician Retention
Get the Trials in Motion
Patient Recruitment
Factors in Recruitment
Importance of Planning
Ethical Considerations
Mass Recruiting
Patient Retention
Ongoing Efforts
Run-In Period
Budgets and Expenditures
For Further Information - Computer-Assisted Data Entry
Pre-Data Screen Development Checklist
Develop the Data Entry Software
Avoid Predefined Groupings in Responses
Screen Development
Radio Button
Pull-Down Menus
Type and Verify
When the Entries are Completed
Audit Trail
Electronic Data Capture
Data Storage: CDISC Guidelines
Testing
Formal Testing
Stress Testing
Training
Reminder
Support
Budgets and Expenditures
For Further Information - Data Management
Options
Flat Files
Hierarchical Databases
Network Database Model
Relational Database Model
Which Database Model?
Object-Oriented Databases
Clients and Servers
One Size Does Not Fit All
Combining Multiple Databases
A Recipe for Disaster
Transferring Data
Quality Assurance and Security
Maintaining Patient Confidentiality
Access to Files
Maintaining an Audit Trail
Security
For Further Information - Are You Ready?
Pharmaceuticals/Devices
Software
Hardware
Documentation
Investigators
External Laboratories
Review Committees
Patients
Regulatory Agency
Test Phase - Monitoring the Trials
Roles of the Monitors
Before the Trials Begin
Kick-Off Meetings
Duties During Trial
Site Visits
Between Visits
Other Duties
Maintaining Physician Interest in Lengthy Trials - Managing the Trials
Recruitment
Supplies
Late and Incomplete Forms
Dropouts and Withdrawals
Protocol Violations
Adverse Events
Quality Control
Visualize the Data
Roles of the Committees
Termination and Extension
Extending the Trials
Budgets and Expenditures
For Further Information - Data Analysis
Report Coverage
Understanding Data
Categories
Metric Data
Statistical Analysis
Categorical Data
Ordinal Data
Metric Data
An Example
Time-to-Event Data
Step By Step
The Study Population
Reporting Primary End Points
Exceptions
Adverse Events
Analytical Alternatives
When Statisticians Can’t Agree
Testing for Equivalence
Simpson’s Paradox
Estimating Precision
Bad Statistics
Using the Wrong Method
Deming Regression
Choosing the Most Favorable Statistic
Making Repeated Tests on the Same Data
Ad Hoc, Post Hoc Hypotheses
Interpretation
Documentation
For Further Information
A Practical Guide to Statistical Terminology - Part III Check
Check
Closure
Patient Care
Data
Spreading the News
Postmarket Surveillance
Budget
Controlling Expenditures
Process Review Committee
Trial Review Committee
Investigatory Drug or Device
Interactions
Adverse Events
Collateral Studies
Future Studies
For Further Information - Appendix Software
Choices
All in One
Almost All in One
Project Management
Data Entry
Handheld Devices
Touch Screen
Speech Recognition
e-CRFs
Do it Yourself
Data Collection Via the Web
Preparing the Common Technical Document
Data Management
Data Entry and Data Management
Small-Scale Clinical Studies
Clinical Database Managers
Data Analysis
Utilities
Sample Size Determination
Screen Capture
Data Conversion
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