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Clinical researchers in developing countries face multiple challenges related to contextual constraints, poor regulation and vulnerability of trials' subjects. The World Health Organization issued in 1995 its Good Clinical Practices (GCP) Guidelines, setting globally applicable standards for clinical trials. Non-compliance with GCP principles leaves room for misconduct and abuse, while a rigid interpretation of GCP processes and procedures may unnecessarily increase the research costs and even prevent research relevant to public health from being carried out. Ethical principles and scientific standards governing research are universal and should be adopted everywhere, to ensure persons' protection and data's reliability, while avoiding any North-South ethical divide. However, principles should be translated into simple and effective processes and procedures, which ensure quality of the research and subjects' protection, without putting unnecessary obstacles to public-health oriented research. It is time to "reinvent" GCP, by updating the 1995 WHO Guidelines in light of the 15-year experience of worldwide implementation. The revision should include old and new stakeholders (including academic institutions from the South and the North, NGOs, public-private partnerships, donors, patients associations etc.) and could, by making clearer distinction between essential and procedural requirements, help researchers and sponsors to design new patient-centered tools and practices.

Type

Journal article

Journal

Giornale Italiano di Medicina Tropicale

Publication Date

01/01/2010

Volume

15

Pages

1 - 8