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Standard of care in clinical trial

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  • hanysafwat8
    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
    Message 1 of 5 , Jan 2, 2009
      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?
    • Azza Saleh
      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
      Message 2 of 5 , Jan 2, 2009
        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 standard of care in clinical trial,BUT,as you mentioned
        sometimes this is difficult in developing countries , the RECs can
        allow it to be best available to study population ,but again this
        depends on the type and severity of disease studied.Generally
        speaking , I am not with considering placebo as one type of care !!!!
        Best and waiting for the replies of our dear friends :)
        Azza













        --- In EGYPTIAN_RECS@yahoogroups.com, "hanysafwat8" <hanysafwat8@...>
        wrote:
        >
        > 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?
        >
      • amr shebaita
        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
        Message 3 of 5 , Jan 3, 2009
          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?


        • hkassem67
          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
          Message 4 of 5 , Jan 4, 2009
            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 under investigation and ofcourse if the standard of care is
            not available due to economic reasons then if the company cannot
            provide the currently available standard of treatment to set a state
            of equipoise then this study should be undertaken in the places where
            the alternative therapy is available. Again I stress that every
            situation has to be weighed according to risk benefit ratio. I can't
            give a final decision whether this is ehtical or not without further
            details are given particularly on the type of disease we are talking
            about and the risks with and without taking the tested medication.
            Thank you for raising this ever lasting point of debate.
            --- In EGYPTIAN_RECS@yahoogroups.com, "hanysafwat8" <hanysafwat8@...>
            wrote:
            >
            > 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?
            >
          • Abdullah Hattab
            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
            Message 5 of 5 , Jan 5, 2009

              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 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......".
              3. 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
               

              Abdulla Saeed Hattab, MPH, PhD
              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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