Sham surgery controls in Parkinson's disease clinical trials: Views of participants

Movement Disorders

Volumn 27, Issue 11, 2012, Pages 1461-1465

  Kim, Scott Y H ^a,b   De Vries, Raymond ^b   Holloway, Robert G ^c,d   Wilson, Renee ^c   Parnami, Sonali ^b   Kim, H Myra ^b   Frank, Samuel ^e   Kieburtz, Karl ^c,d  

^a UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

^c UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^d UNIVERSITY OF ROCHESTER   (United States)

^e BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Bioethics; Gene therapy; Parkinson's disease; Sham surgery

Indexed keywords

PLACEBO;

ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DECISION MAKING; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PARKINSON DISEASE; PRIORITY JOURNAL; SHAM PROCEDURE;

ATTITUDE; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; MALE; PARKINSON DISEASE; QUESTIONNAIRES; RESEARCH DESIGN;

EID: 84866629832     PISSN: 08853185     EISSN: 15318257     Source Type: Journal    
DOI: 10.1002/mds.25155     Document Type: Article

References (12)

1. Gross RE, Watts RL, Hauser RA, et al. Intrastriatal transplantation of microcarrier-bound human retinal pigment epithelial cells versus sham surgery in patients with advanced Parkinson's disease: a double-blind, randomised, controlled trial. Lancet Neurol 2011; 10: 509-519.
2. LeWitt PA, Rezai AR, Leehey MA, et al. AAV2-GAD gene therapy for advanced Parkinson's disease: a double-blind, sham-surgery controlled, randomised trial. Lancet Neurol 2011; 10: 309-319.
3. Marks WJ Jr, Bartus RT, Siffert J, et al. Gene delivery of AAV2-neurturin for Parkinson's disease: a double-blind, randomised, controlled trial. Lancet Neurol 2010; 9: 1164-1172.
4. Kim SYH, Frank S, Holloway R, Zimmerman C, Wilson R, Kieburtz K. Science and ethics of sham surgery: a survey of Parkinson disease clinical researchers. Arch Neurol 2005; 62: 1357-1360.
5. Alterman RL, Tagliati M, Olanow CW. Open-label surgical trials for Parkinson disease: time for reconsideration. Ann Neurol 2011; 70: 5-8.
6. Katsnelson A. Experimental therapies for Parkinson's disease: why fake it? Nature 2011; 476: 142-144.
7. Macklin R. The ethical problems with sham surgery in clincial research. N Engl J Med 1999; 341: 992-996.
8. Pollack A. Parkinson's patients suing Amgen over drug. New York Times April 27, 2005.
9. Kim SYH, Wilson RM, Kim HM, et al. Comparison of enrollees and decliners of Parkinson disease sham surgery trials. Mov Disord 2012; 27: 506-511.
10. Kim SYH, Schrock L, Wilson RM, et al. An approach to evaluating the therapeutic misconception. IRB 2009; 31: 7-14.
11. Frank S, Kieburtz K, Holloway R, Kim SYH. What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports. Neurology 2005; 65: 1101-1103.
12. Agrawal M, Emanuel EJ. Ethics of phase 1 oncology studies: reexamining the arguments and data. JAMA 2003; 290: 1075-1082.