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