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Clinical Trial in developing countries

Rome -

International Round Table on problems of clinical trials in developing countries

UNICRI and the Italian Drug Agency will present a research symposium on ethical and legal issues related to the various stages of clinical trials in developing countries. The Round Table is to be held on December 15-16 in Rome at FAO, Viale delle Terme di Caracalla, starting at 9am. In recent years, the proliferation of clinical research on human beings in these countries have raised concerns about the ethical and legal implications associated with the poor conduct of trials, the violation of human rights and welfare of participants pertaining to an inadequate review of ethics and scientific protocols and absence of an inadequate system of regulation of medicines.
A particular focus is devoted to the level of protection for participants and legislation put forth in Biomedical Research in Africa to identify the countries which require more urgent and specific training on the review of ethics in the protocols on inspections of good clinical practice and the problems connected to strengthening legislation.
The Roundtable will also provide an opportunity to compare experiences on the protection of participants in clinical trials between national and international institutions and promote the needs, expectations and proposals coming from the field in order to better plan future training programs and development through the efforts of international organizations and civil society, and to improve universal instruments in biomedicine to effectively regulate clinical trials.

Please find below the International Round Table Conclusions and Recommendations.

  • AIFA Conclusions
  • UNICRI Recommendations