If it is a disease that is only in egypt and there is no standard of care, then this is accepted. but if it is a world wide disease and there is a standard of care any where in the world then it is mandatory not to include a placebo in the study. Including a palcebo while there is a standard of care is unethical based on the exploitation and coercion . The justification of my opinion is that if the drug company wants to conduct the clinicl trial in Egypt only becuase it has no standard of care for a disease then this is an exploitation of the whole country. Also by logic:if there is a standard of care for a disease then it is the best for results of the clinical trial to be done with the a standard of care so the trial is evidance based.
The solution? The drug company should make the clinical trial with the known standard of care and provide it to the subjects who will be enrolled where the first group recieves the clinical trial and the second recives the standard of care.
Amr Shebaita B.D.S.,M.Sc.D
Research Assistant Ethics Consultant For Dental, Oral and Maxillofacial Research
Certified Trainer in Health Research Ethics, University of Maryland, USA Scientific Coordinator For International Visiting Professors Department of Oral and Dental Medicine Research Medical Research Division National Research Centre 33 El Bohouth St.(Ex El-Tahrir), Dokki, Cairo 12311, Egypt cell phone#: --- On Fri, 1/2/09, hanysafwat8 <hanysafwat8@...> wrote: From: hanysafwat8 <hanysafwat8@...> |