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Dear Dr. Hany,
Thank you very much for raising this important question.
- The main role of the RECs is the protection of the research participants.
- in my opinion new drugs should be tested against the best available world-wide treatment. This opinion is based on paragragh No.29 of the Declaration of Helsinki, that staes, "The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods......".
- The unavailability of standard treatment in developing countries, could not justify the use of placebo in clinical trials - in the presence of a standard treatment elswhere- because it constitutes gross exploitation of the research partcipants. It is the role of the RECs to safeguard the interest of the research participants and prevent their exploitation.
Best regards,
Abdallah
Professor of Social Medicine and Public Health
Aden University
Tel: +967 2 231403
Fax: +967 2 231788
Mobile: +967 733311900
POBox: 6165 (Khormaksar)
ADEN-YEMEN
From: hanysafwat8 <hanysafwat8@...>
To: EGYPTIAN_RECS@yahoogroups.com
Sent: Friday, January 2, 2009 14:43:07
Subject: [EGYPTIAN_RECS] Standard of care in clinical trial
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?
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