Editor's response to "Ethical issues associated with globalization of placebo-controlled trials in pulmonary arterial hypertension"

Journal of Heart and Lung Transplantation

Volumn 29, Issue 7, 2010, Pages 827-828

  Park, Myung H ^a   Rubin, Lewis J ^b  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENDOTHELIN RECEPTOR ANTAGONIST; PHOSPHODIESTERASE INHIBITOR; PLACEBO; PROSTANOID; UNIPROST;

CLINICAL RESEARCH; HUMAN; LETTER; MEDICAL ETHICS; MEDICAL LITERATURE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PULMONARY HYPERTENSION; TREATMENT RESPONSE;

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

EID: 77953714514     PISSN: 10532498     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.healun.2010.03.009     Document Type: Letter

References (14)

1. 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
2. Park M.H., and Rubin L.J. The globalization of clinical trials in pulmonary arterial hypertension. J Heart Lung Transplant 29 (2010) 157-158
3. Miller F.G., and Brody H. What makes placebo-controlled trials unethical?. Am J Bioethics 2 (2002) 3-9
4. van der Graaf R., and van Delden J.J.M. What is the best standard for the standard of care in clinical research?. Am J Bioethics 9 (2009) 35-43
5. Declaration of Helsinki. World Medical Association. http://www.wma.net/en30publications/10policies/b3/index.html
6. Halpern S.D., Doyle R., and Kawut S.M. The ethics of randomized clinical trials in pulmonary arterial hypertension. Proc Am Thorac Soc 15 (2008) 631-635
7. Farber HW, Walkey AJ, O'Donnell MR. Ethical issues associated with globalization of placebo-controlled trials in pulmonary arterial hypertension. J Heart Lung Transplant (ahead of print).
8. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infraction. N Engl J Med 2989;321:406-12.
9. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med 336 (1997) 525-533
10. Maron B.J., Nishimura R.A., McKenna W.J., et al. Assessment of permanent dual-chamber pacing as a treatment for drug-refractory symptomatic patients wtih obstructvie hypertrophic cardiomyopathy. A randomized, double-blind, crossover study (M-PATHY). Circulation 99 (1999) 2927-2933
11. Laliberte K., Arneson C., Jeffs R., et al. Pharmacokinetics and steady-state bioequivalence of treprostinil sodium (Remodulin) administered by the intravenous and subcutaneous route to normal volunteers. J Cardiovasc Pharmacol 44 (2004) 209-214
12. Badesch D.B., Abman S.H., Simmonneau G., et al. Medical therapy for pulmonary arterial hypertension: updated ACCP evidence-based clinical practice guidelines. Chest 131 (2007) 1917-1928
13. Wegman D.H., and Major E. Protecting human subjects: how much responsibility falls to editorial boards?. Am J Indust Med 52 (2009) 172-175
14. van Giersbergen P.L.M., Gunawardena K.A., and Dingemanse J. Influence of ethnic origin and sex on the pharmacokinetics of clozosentan. J Clin Pharmacol 47 (2007) 1374-1380