A Managers Guide to the Design and Conduct of Clinical Trials

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 thereStaffing for successDesigning trials and determining sample sizeBudgetingRecruiting and retaining patients and physiciansData managementMonitoring the trialsData analysisAfter action reviewException 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

Spis treści:
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 Decis ions.
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.
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.
7. 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.
8. 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 Ma nuals.
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.
9. 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.
10. 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.
11. 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.
12. Are You Ready?
Pharmaceuticals/Devices.
Software.
Hardware.
Documentation.
Investigators.
External Laboratories.
Review Committees.
Patients.
Regulatory Age