The ethics of sham invasive intervention trials

Clinical Trials

Volumn 6, Issue 5, 2009, Pages 401-402

  Miller, Franklin G ^a   Wendler, David ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

ANALGESIA; CHRONIC PANCREATITIS; CLINICAL RESEARCH; EDITORIAL; ENDOSCOPIC SURGERY; INTERMETHOD COMPARISON; INTERVENTION STUDY; INVASIVE PROCEDURE; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; PLACEBO EFFECT; PREVALENCE; PRIORITY JOURNAL; RANDOMIZATION; RESEARCH ETHICS; RESEARCH SUBJECT; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK REDUCTION; SHAM PROCEDURE; STENT; SURGEON; SURGICAL RISK;

CLINICAL TRIALS AS TOPIC; HUMANS; PLACEBOS; RESEARCH DESIGN; RISK ASSESSMENT;

EID: 71049169642     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774509344146     Document Type: Editorial

References (6)

1. Wilcox CM, Lopes TL A randomized trial comparing endoscopic stenting to a sham procedure for chronic pancreatitis. Clin Trials 2009; 6: 455-63.
2. Cahen DL, Gouma DJ, Nio Y. et al. Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis. N Engl J Med 2007; 356: 676-84.
3. Flory JH, Wendler D., Emanuel E. Empirical Issues in Informed Consent for Research. The Oxford Textbook on Clinical Research Ethics. Oxford University Press, Oxford, 2008.
4. Moseley JB, O'Malley K., Petersen NJ et al. A controlled trial of arthroscopic intervention for osteoarthritis of the knee. N Engl J Med 2002; 347: 81-88.
5. Wendler D. Can we ensure all research subjects give valid consent? Arch Intern Med 2004; 164: 2201-04.
6. Miller FG, Kaptchuk TJ Sham procedures and the ethics of clinical trials. J Roy Soc Med 2004; 97: 576-78.