title: Trials and tribulations: current challenges in conducting clinical trials.
abstract: Randomized controlled trials are the gold standard for the evaluation of new therapies and surgical procedures and as such require strict attention to study design and statistical analysis. There are, however, multiple challenges in conducting a well-designed clinical trial. This article describes the difficulties encountered at a single institution participating in a multicenter drug study and reviews the challenges involved in developing a high-quality randomized controlled study.
authors.affiliation: Department of Surgery, University of Washington, Box 356410, 1959 NE Pacific St, Seattle, WA 98125, USA.
authors.forename: Lillian S
authors.initials: LS
authors.lastname: Kao
authors.forename: Beth C
authors.initials: BC
authors.lastname: Aaron
authors.forename: E Patchen
authors.initials: EP
authors.lastname: Dellinger
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use; D004338:Drug Combinations; D006801:Humans; D006853:Hydrocodone / Q000627:therapeutic use; D007258:Informed Consent / Q000592:standards; D007527:Isoenzymes / Q000037:antagonists & inhibitors; D008565:Membrane Proteins; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000592:standards*; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D018579:Patient Selection; D011451:Prostaglandin-Endoperoxide Synthases; D016032:Randomized Controlled Trials as Topic / Q000592:standards*
chemical_list: D000700:Analgesics; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D004338:Drug Combinations; D007527:Isoenzymes; D008565:Membrane Proteins; D000082:Acetaminophen; D006853:Hydrocodone; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases