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Clinical trials in developing countries

Clinical trials in developing countries. HAI Europe Open Seminar 21 November 2008 Annelies den Boer. Ski where the snow is!. Discover Russia for conducting clinical research!. Billion dollar clinical research opportunity lies in India!. Dr. Amar Jessani.

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Clinical trials in developing countries

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  1. Clinical trials in developing countries HAI Europe Open Seminar 21 November 2008 Annelies den Boer

  2. Ski where the snow is!

  3. Discover Russia for conducting clinical research!

  4. Billion dollar clinical research opportunity lies in India!

  5. Dr. Amar Jessani Many doctors in India involved in clinical trials are given enormous sums of money for recruiting patients. This leads to a conflict of interests, of which the patients are the victims. When they find they need medical attention, the financial obstacles they encounter tempt them to close their eyes to the possible risks of clinical trials.’

  6. Tests increasingly carried out in low income countries • Popular destinations; Eastern Europe, Asia and Latin America • Often medicines destined for consumption in lucrative Western Markets

  7. Cheap Fast Easy

  8. Scale of CT outside US/ W.Europe No universal registration system Scientists: 30 - 40 % Big pharma: 30 - 70% NGO’s: more CRO’s Estimate SOMO: 18.000- 24.000 CTs

  9. Why be concerned? No access Conflicts of interest Insufficient supervision

  10. Protection of participants Declaration of Helsinki Violations by Pfizer, Occam, Astra Zeneca

  11. What to do? CT Watch Lobby against market authorisation in EU Capacity building Compulsory and public registration

  12. European bottlenecks Lack of implementation of EU directives Medicines agencies: ‘It is not in our system’

  13. Change? 13 MEP’s support position Wemos Dutch MP’s questioned Minister New study and call for ethical trials

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