Ethical issues associated with globalization of placebo-controlled in pulmonary arterial hypertension

Journal of Heart and Lung Transplantation

Volumn 29, Issue 7, 2010, Pages 825-826

  Farber, Harrison W ^a   Walkey, Allan J ^a   O'Donnell, Max R ^a  

^a BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; VASODILATOR AGENT;

CENTRAL VENOUS CATHETER; CLINICAL ASSESSMENT; DRUG EFFICACY; DRUG SAFETY; HUMAN; INVASIVE PROCEDURE; LETTER; LONG TERM CARE; MEDICAL ETHICS; MEDICAL RESEARCH; MORTALITY; PRIORITY JOURNAL; PULMONARY HYPERTENSION;

CATHETERIZATION, CENTRAL VENOUS; CONTROLLED CLINICAL TRIALS AS TOPIC; DEVELOPED COUNTRIES; HUMANS; HYPERTENSION, PULMONARY; INTERNATIONALITY; PLACEBOS; VASODILATOR AGENTS;

EID: 77953706099     PISSN: 10532498     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.healun.2010.03.010     Document Type: Letter

References (7)

1. Declaration of Helsinki, and World Medical Association. http://www.wma.net/en/30publications/10policies/b3/index.html (accessed February 8, 2010)
2. Hiremath J., Thanikachalam S., Parikh K., et al. Exercise improvement and plasma biomarker changes with intravenous treprostinil therapy for pulmonary arterial hypertension: a placebo-controlled trial. J Heart Lung Transplant 29 (2010) 137-149
3. Park M.H., and Rubin L.J. The globalization of clinical trials in pulmonary arterial hypertension. J Heart Lung Transplant 29 (2010) 157-158
4. Hellman D.L., Brown A.W., Jackson J.L., et al. Analyzing the short-term effect of placebo therapy in pulmonary arterial hypertension potential implications for the design of future clinical trials. Chest 132 (2007) 764-772
5. Galiè N., Manes A., Negro L., et al. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension. Eur Heart J 30 (2009) 394-403
6. Halpern S.D., Doyle R., and Kawut S.M. The ethics of randomized clinical trials in pulmonary arterial hypertension. Proc Am Thorac Soc 5 (2008) 631-635
7. Angell M. The ethics of clinical research in the Third World. N Engl J Med 337 (1997) 847-849