Trial Design: Overview of Study Designs (Phase I, II, III, IV, Factorial Design)
Fig. 14.1 Phases of clinical trials – 0, 1, 2, 3, 4 14.3.1 Phase 0 Phase 0 trials are preclinical trials and are intended to expedite the clinical evaluation of…
GENERAL & FAMILY MEDICINE
The History of Clinical Trials
Fig. 12.1 Vaticanus graecus 277, 10v-11r: table of contents in a fourteenth-century Hippocratic Corpus manuscript. Marcus Fabius Calvus owned this manuscript, transcribed it in his own hand, and used it…
Ethics of Clinical Trials
Guideline Source Date Reference Nuremberg Code Nuremberg Military Tribunal United States v. Brandt et al. 1947 http://www.hhs.gov/ohrp/archive/nurcode.html Declaration of Helsinki World Medical Association 1964 http://www.wma.net/en/30publications/10policies/b3/index.html Belmont Report National Commission for…
Defining the Study Cohort: Inclusion and Exclusion Criteria
Fig. 11.1 CONSORT statement 2010 flow diagram 11.6 Modifying Selection Criteria Under certain circumstances, it may be necessary to modify the original study eligibility criteria after recruitment has been initiated….
Device Versus Drug Clinical Trials: Similarities and Important Differences
Timothy M. Pawlik and Julie A. Sosa (eds.)Success in Academic SurgerySuccess in Academic Surgery: Clinical Trials201410.1007/978-1-4471-4679-7_10 © Springer-Verlag London 2014 10. Device Versus Drug Clinical Trials: Similarities and Important Differences T. Clark Gamblin1 and William S. Ragalie1 (1) Department…
Data Safety Monitoring Boards
1. High risk or vulnerable populations 2. Trials investigating new interventions with few or no safety data available 3. Trials with primary endpoints such as mortality or major morbidity 4….
Clinical Trials: Handling the Data
Died Survived Drug A 27 498 525 Placebo 75 500 575 102 998 1,100 The row totals are the total number of patients receiving Drug A and placebo, whereas…
Statistics: Setting the Stage
Fig. 3.1 Power curve. A power curve demonstrates the increasing differences (δ) between the control group and the intervention group with a one-sided significance level of 0.05 and a total…
Regulatory Considerations in Human Subjects Research
1. The voluntary consent of the human subject is absolutely essential. The person involved should have legal capacity to give consent; should be so situated as to be able to…
Planning for Data Monitoring and Audits
Timothy M. Pawlik and Julie A. Sosa (eds.)Success in Academic SurgerySuccess in Academic Surgery: Clinical Trials201410.1007/978-1-4471-4679-7_6 © Springer-Verlag London 2014 6. Planning for Data Monitoring and Audits Lisa Jacobs1 (1) Department of Surgery, Johns Hopkins University,…
