In June 1993, a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although, all the remaining patients
Clinical trials
β Scribed by Pawlik, Timothy M.;Sosa, Julie Ann
- Publisher
- Springer
- Year
- 2014
- Tongue
- English
- Leaves
- 197
- Series
- Success in academic surgery
- Category
- Library
No coin nor oath required. For personal study only.
β¦ Synopsis
Success in Academic Surgery: Clinical Trials is a unique and portable handbook that focuses on clinical trials. It includes new educational materials which are necessary to address not only the rapid evolution and rise of novel research methodologies in basic science and clinical/educational research, but also the changing environment for academic surgeons. Aimed at medical students, surgical residents and others considering a career within surgery, Success in Academic Surgery: Clinical Trials is a valuable text which offers practical guidance on developing a career within surgical education. Written by expert authors from around the world who are members of the AAS (Association for Academic Surgery), this book looks at all aspects of clinical trials, from trial design and building a research team to statistics and getting your trial published.;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).
β¦ Table of Contents
- 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).
β¦ Subjects
Academic Medical Centers;Clinical trials;Clinical Trials as Topic--methods;General Surgery;Surgery--Research--Methodology;Surgery -- Research -- Methodology;Clinical Trials as Topic -- methods
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