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Good clinical practice in developing countries: applying recommendations.

François Bompart1, François Hirsch, Pierre-Henri Bertoye

  • 1Direction Accès au Médicament, Sanofi Aventis, Paris, France. francois.bompart@sanofi-aventis.com

Therapie
|June 20, 2008
PubMed
Summary
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This article addresses critical issues in clinical research in developing countries, expanding on 2007 recommendations. It focuses on informed consent, ethics review, and safety reporting for international trials.

Area of Science:

  • Clinical Research Ethics
  • International Health Regulations
  • Global Clinical Trials

Background:

  • Clinical research recommendations for developing nations were established in 2007.
  • Certain critical issues require further in-depth discussion and clarification.
  • This article builds upon existing guidelines to address emerging challenges.

Purpose of the Study:

  • To explore specific, underexplored ethical and logistical issues in clinical trials conducted in developing countries.
  • To provide nuanced guidance on complex aspects of international research conduct.
  • To enhance the ethical and operational standards of global health research.

Main Methods:

  • Qualitative analysis of previously unaddressed issues in clinical research.

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  • Discussion and elaboration on key ethical considerations.
  • Review of specific operational challenges in multinational research settings.

    • Main Results:

    • Identified and discussed critical areas including informed consent processes.
    • Addressed the dual ethics committee review requirement and standards of care.
    • Examined management of biological samples, follow-up committees, and Serious Adverse Event (SAE) reporting.

    Conclusions:

    • There is a need for expanded guidance beyond the 2007 recommendations for clinical research in developing countries.
    • Specific attention to paediatric trials and the role of Contract Research Organizations (CROs) is crucial.
    • Addressing these nuanced issues will improve the quality and ethical integrity of global clinical research.