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article · PLoS neglected tropical diseases

Implementation of good clinical practice in clinical research in the context of limited resources settings: Lessons learnt from the freeBILy trial using an embedded mixed methods approach

20261 citationOpen accessUniversity Of Antananarivo

Abstract

This study shows the limitations of datacentric clinical trial management to assess GCP performances in the frame of clinical trials in resource-limited settings. We highlight the importance of well-trained and integrated study staff, as well as thorough preparation, budgeting and context appropriate monitoring. This achieves high quality, patient centered and compliant research, implemented through alternative frameworks for monitoring and evaluation.

Research topics

  • Ethics in Clinical Research
  • Health Policy Implementation Science
  • Global Health and Surgery

Sustainable Development Goals

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DOI: 10.1371/journal.pntd.0013899

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