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Standard of care in clinical trial   Message List  
Reply | Forward Message #31 of 190 |
Re: [EGYPTIAN_RECS] Standard of care in clinical trial

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#:  +20105249889 


--- On Fri, 1/2/09, hanysafwat8 <hanysafwat8@...> wrote:
From: hanysafwat8 <hanysafwat8@...>
Subject: [EGYPTIAN_RECS] Standard of care in clinical trial
To: EGYPTIAN_RECS@yahoogroups.com
Date: Friday, January 2, 2009, 1:43 PM

Dear friends and colleagues

We all know that guidelines obligate the testing of new drug against
standard of care but some time in developing countries like Egypt where
standard of care is not available placebo can be considered a standard
of care.

Should RECs allow the standard of care in clinical trial to be the best
available to study population or best available world-wide?

Your thoughts and why?




Sat Jan 3, 2009 8:18 am

amrshebaita
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Message #31 of 190 |
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Dear friends and colleagues We all know that guidelines obligate the testing of new drug against standard of care but some time in developing countries like...
hanysafwat8
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Jan 2, 2009
11:43 am

Dear Hany; thank you for the important question and debate you raised by it; in my opinion the best -of course- is to offer the best available world- wide...
Azza Saleh
azzasaleh187
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Jan 3, 2009
4:47 am

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...
amr shebaita
amrshebaita
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Jan 3, 2009
8:18 am

Dear Friends, Isn't this the point of debate since the start of research ethics starting from the Tuskeeji study?? I believe this will depend on the disease...
hkassem67
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Jan 4, 2009
2:58 pm

Dear Dr. Hany, Thank you very much for raising this important question. 1. The main role of the RECs is the protection of the research participants. 2. in my...
Abdullah Hattab
hattabas
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Jan 5, 2009
9:14 pm
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