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Clinical Trials / / edited by Timothy M. Pawlik, Julie A. Sosa
| Clinical Trials / / edited by Timothy M. Pawlik, Julie A. Sosa |
| Edizione | [2nd ed. 2020.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 |
| Descrizione fisica | 1 online resource (VI, 258 p. 26 illus., 16 illus. in color.) |
| Disciplina | 617 |
| Collana | Success in Academic Surgery |
| Soggetto topico |
Surgery
Medical education Medical Education |
| ISBN | 3-030-35488-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | History of Clinical Trials -- Ethics (COI, informed consent) -- Generating a Testable Hypothesis and Underlying Principles of Clinical Trials -- Trial Design: Overview of Study Designs (phase I, II, III, IV, factorial design) -- Defining the Study Cohort: Inclusion and Exclusion criteria (establishing eligibility and exclusion criteria, how should one define a cohort, balance between being inclusive versus selective / efficacy versus effectiveness trials) -- Building your Clinical Trial Research Team (how to assemble the team: database manager, research nurse) -- Clinical Trials: Ensuring Quality and Standardization (GCP, reporting of AE’s, establishing SOPs, CRF’s) -- Device versus Drug Clinical Trials: Similarities and Important Differences -- Statistics – Setting the Stage (Sample Size, Power, Randomization, Type II error, Treatment allocation/stratification) -- Statistics – Handling the Data (Intention to Treat analyses, Subgroups analyses, expressing the data (relative risk), handling missing data) -- Data Safety Monitoring Board: Interim Analyses, Stopping Rules -- Planning for Data Monitoring and Audit -- Clinical Trials: The Budget -- Regulatory Issues (compliance issues, IRB, FDA) -- Publishing your Clinical Trial (authorship, manuscript preparation, journal selection) -- Pragmatic clinical trials -- Cooperative trials -- International trials -- Inclusion of Patient Reported Outcomes -- Participation in clinical trials/as a clinical trialist for the community surgeon. . |
| Record Nr. | UNINA-9910383843503321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Success in Academic Surgery: Clinical Trials / / edited by Timothy M. Pawlik, Julie A. Sosa
| Success in Academic Surgery: Clinical Trials / / edited by Timothy M. Pawlik, Julie A. Sosa |
| Edizione | [1st ed. 2014.] |
| Pubbl/distr/stampa | London : , : Springer London : , : Imprint : Springer, , 2014 |
| Descrizione fisica | 1 online resource (197 p.) |
| Disciplina | 617.00711 |
| Collana | Success in Academic Surgery |
| Soggetto topico |
Medicine
Surgery Medical education Medicine/Public Health, general Medical Education |
| ISBN | 1-4471-4679-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Building your Clinical Trial Research Team -- 2. Clinical Trials: Ensuring Quality and Standardization -- 3. Statistics - Setting the Stage -- 4. Clinical Trials: Handling the Data -- 5. Data Safety Monitoring Boards -- 6. Planning for Data Monitoring and Audits -- 7. The Budget -- 8. Regulatory Considerations in Human Subjects Research -- 9. Publishing a Clinical Trial -- 10. Device Versus Drug Clinical Trials: Similarities and Important Differences -- 11. Defining the Study Cohort: Inclusion and Exclusion Criteria -- 12. History of Clinical Trials -- 13. Ethics of Clinical Trials -- 14. Trial Design: Overview of Study Designs (Phase I, II, III, IV, Factorial Design). |
| Record Nr. | UNINA-9910300345903321 |
| London : , : Springer London : , : Imprint : Springer, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||