Clinical trials /
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Edition: | Second edition. |
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Imprint: | Cham : Springer, [2020] ©2020 |
Description: | 1 online resource |
Language: | English |
Series: | Success in academic surgery Success in academic surgery. |
Subject: | |
Format: | E-Resource Book |
URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/12604225 |
Table of Contents:
- 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 AEs, establishing SOPs, CRFs)
- 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.