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 | |
Plan | |
Prescription for Success | |
Plan | |
Predesign Phase | |
Design the Trials Do | |
Obtain Regulatory Agency Approval for the Trials | |
Form the Implementation Team | |
Line Up Your Panel of Physicians | |
Develop the Data Entry Software | |
Test the Software | |
Train | |
Recruit Patients | |
Set Up External Review Committee | |
Conduct the Trials | |
Develop Suite of Programs for Use in Data Analysis | |
Analyze and Interpret the Data Check | |
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? | |
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 Ph | |
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