Top
| 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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