title: Good clinical practice in resource-limited settings: translating theory into practice.
abstract: 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.
authors.affiliation: Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso. tintohalidou@yahoo.fr
authors.forename: Halidou
authors.initials: H
authors.lastname: Tinto
authors.forename: Ramadhani A
authors.initials: RA
authors.lastname: Noor
authors.forename: Charles L
authors.initials: CL
authors.lastname: Wanga
authors.forename: Innocent
authors.initials: I
authors.lastname: Valea
authors.forename: Maimouna Ndour
authors.initials: MN
authors.lastname: Mbaye
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.forename: Raffaella M
authors.initials: RM
authors.lastname: Ravinetto
mesh_terms: D035843:Biomedical Research / Q000193:education* / Q000379:methods / Q000592:standards; D002050:Burkina Faso; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic; D032984:Ethics, Research; D006268:Health Facilities / Q000592:standards; D006282:Health Personnel / Q000193:education* / Q000458:organization & administration; D006801:Humans; D015397:Program Evaluation; D000078329:Workforce
references.citation: Lancet. 2010 Dec 4;376(9756):1923-58
references.pmid: 21112623
references.citation: Am J Trop Med Hyg. 2011 Dec;85(6):971-8
references.pmid: 22144429
references.citation: Bull Med Ethics. 2002 Oct;(182):17-23
references.pmid: 14983848
references.citation: J Infect Dis. 2004 Mar 1;189(5):930-7
references.pmid: 14976611
references.citation: J Am Coll Dent. 2014 Summer;81(3):4-13
references.pmid: 25951677
references.citation: Lancet. 2007 Apr 14;369(9569):1233
references.pmid: 17434377
references.citation: Nat Med. 2010 Jan;16(1):8
references.pmid: 20057398
references.citation: Trop Med Int Health. 2009 Nov;14(11):1327-8
references.pmid: 19840349
references.citation: Trop Med Int Health. 2011 Apr;16(4):527-30
references.pmid: 21410849
references.citation: Lancet. 2011 May 7;377(9777):1553-5
references.pmid: 21334737
references.citation: N Engl J Med. 1997 Sep 18;337(12):847-9
references.pmid: 9295243
references.citation: N Engl J Med. 2009 Feb 19;360(8):816-23
references.pmid: 19228627
references.citation: JAMA. 1996 Nov 27;276(20):1691
references.pmid: 11644854