Design and conduct issues in surgical clinical trials.
The design and conduct of surgical clinical trials present unique challenges to the investigator that are not encountered in drug studies. Using the Veterans Affairs Cooperative Studies Program Hernia Trial as a case study, this article explores the potential problems and solutions.
Neumayer
Leigh
L
Salt Lake City Veterans Affairs Medical Center and the Department of Surgery, University of Utah School of Medicine, 50 North Medical Drive, Salt Lake City, Utah 84132, USA. leigh.neumayer@hsc.utah.edu
D002986:Clinical Trials as Topic / Q000379:methods*; D003142:Communication; D006552:Hernia, Inguinal / Q000601:surgery; D006801:Humans; D018579:Patient Selection; D011643:Publishing; D012107:Research Design / Q000592:standards*; D013514:Surgical Procedures, Operative / Q000009:adverse effects / Q000379:methods; D014481:United States; D014493:United States Department of Veterans Affairs