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A manager's guide to the design and conduct of clinical trials [[electronic resource] /] / Phillip I. Good
| A manager's guide to the design and conduct of clinical trials [[electronic resource] /] / Phillip I. Good |
| Autore | Good Phillip I |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Hoboken, NJ, : Wiley-Liss, c2006 |
| Descrizione fisica | 1 online resource (274 p.) |
| Disciplina |
610.72/4
610.724 |
| Soggetto topico |
Clinical trials
Clinical medicine - Research |
| ISBN |
1-280-44821-0
9786610448210 0-470-32719-7 0-471-93091-1 0-471-93087-3 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
A MANAGER'S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS; Contents; 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 PhysiciansF. 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 PatientsTransnational Trials; Conduct the Trials; Programs for Data Analysis; Analyze and Interpret the Data; The People You Don't Need; For Further Information; 5 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 ExpendituresFor 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 NoncomplianceAdverse 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 |
| Record Nr. | UNINA-9910841353303321 |
Good Phillip I
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| Hoboken, NJ, : Wiley-Liss, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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