Our colleagues at The Association for Data Management in the Tropics (ADMIT) recently shared with us a publication that we believe would be of general interest to the Global Health Network community. This is an article published in December 2012 in the American Jornal of Tropical Medicine and Hygiene (AJTMH), which recounts the experiences of a theoretical and practical GCP course that took place in Burkina Faso in 2010, as part of the Switching the Poles Network initiative. The Switching the Poles Clinical Research Network develops the capacity, tools and procedures to apply universal standards for clinical research in resource-poor settings. It is coordinated by the Antwerp Institute of Tropical Medicine and brings together clinical researchers from Belgium, Benin, Burkina Faso, Cambodia, Cuba, DRC, Ethiopia, Indonesia, Nepal, Peru, Uganda, Vietnam and Zambia. More can be read about this network by clicking on this link and navigating to the bottom of the page.
The full reference is: H into, RA Noor, CL Wanga, I Valea, M Ndour Mbaye, U D'Alessandro, and RM Ravinetto. Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice. Am J Trop Med Hyg 2013;88 608-613
With this piece, the authors hope to stimulate further debate on the need to rethink the traditional the GCP training, by bringing theorical learning together with field practice, rather than relying on theoretical training only. This theroretical & practical approach helps the trainees to translate the newly-acquired knowledge in concrete skills, and it also connect them immediately to the real challenges faced when conduction medical research in resource-constrained settings.
The abstract of the article in the AJTMH can be accessed by clicking here:
A Good Clinical Practices (GCPs) course, based on the combination of theoretical modules with a practical training in real-life conditions, was held in 2010 in Burkina Faso. It was attended by 15 trainees from nine African, Asian, and Latin American countries. There were some discrepancies between the average good results at the end of the theoretical phase and the GCP application during the first days of the practical phase, underlying the difficulties of translating theoretical knowledge into good practices. Most of the findings were not unexpected and reflected the challenges commonly faced by clinical investigators in resource-poor contexts (i.e., the high workload at peripheral health facilities, the need to conciliate routine clinical activities with clinical research, and the risk of creating a double standard among patients attending the same health facility [free care for recruited patients versus user fees for non-recruited patients with the same medical condition]). Even if limited in number and time, these observations suggest that a theoretical training alone may not be sufficient to prepare trainees for the challenges of medical research in real-life settings. Conversely, when a practical phase immediately follows a theoretical one, trainees can immediately experience what the research methodology implicates in terms of work organization and relationship with recruited and non-recruited patients. This initial experience shows the complexity of translating GCP into practice and suggests the need to rethink the current conception of GCP training.
read through also and understood.
This is one relevant topic we need to discuss that would facilitate conduct of clinical research in low income countries. I come from Nepal. There are many studies that are being conducted in random manner. But one question that we should be raising now is, "are we conducting these studies as per ICH / WHO GCP standards and how about Ethical bodies - are they constituted well and functioning as per required process? I am raising this question because i came to know a pathetic situation in a leading medical college, which runs post graduation courses and can you imagine - IRB is not functioning properly !!!