Clinical Trials: Ensuring Quality and Standardization
Fig. 2.1 Example of case report form template 2.5 Adverse Event Reporting While the CRF records all events in a trial related to each subject, a subset of the record…
Publishing a Clinical Trial
Fig. 9.1 CONSORT 2010 checklist of information to include when reporting a randomized trial In general, the manuscript should focus on what is novel about the study and what it…
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…
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….
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,…
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…
