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
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.
Authors
- Leonard Gunga
- Pia Rausche (ORCID: https://orcid.org/0009-0002-3554-617X)
- Rivo Andry Rakotoarivelo (ORCID: https://orcid.org/0000-0003-3438-8624)
- Daniela Fusco (ORCID: https://orcid.org/0000-0001-8833-239X)
- Aaron Remkes (ORCID: https://orcid.org/0000-0003-0229-1991)
- Raphaël Rakotozandrindrainy
- Valentina Marchese (ORCID: https://orcid.org/0000-0002-5221-1614)
- Jeannine Solonirina
- Mickael Radomanana
- Elveric Fesia
- Norbert Georg Schwarz
- RMJ Razafindrakoto
- Jean-Marc Kutz
- Anna Jager
- Nagham Issa
- Dewi Ismajani Puraduredja
- Natalie Fischer
- Govert van Dam
- Njary Rakotozandrindrainy
- Mandranto Rasamoelina
- Jürgen May
Institutions
- University of Antananarivo (MG)
- Leiden University Medical Center (NL)
- Université de Fianarantsoa (MG)
- German Center for Infection Research (DE)
- Bernhard Nocht Institute for Tropical Medicine (DE)
Publication Details
- Journal
- PLoS neglected tropical diseases
- Published
- 2026-02-09
- DOI
- https://doi.org/10.1371/journal.pntd.0013899
- Citations
- 1
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 41.85