Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice

Halidou Tinto Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso; QGates Clinical Research Organization, Dar es Salaam, Tanzania; African Malaria Network Trust, Dar es Salaam, Tanzania; Service de Médecine Interne, Hopital Abass Ndao, Dakar, Senegal; Malariology Unit, Institute of Tropical Medicine, Antwerp, Belgium; Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Disease Control and Elimination, Medical Research Council Unit, Banjul, The Gambia; Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium

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Ramadhani A. Noor Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso; QGates Clinical Research Organization, Dar es Salaam, Tanzania; African Malaria Network Trust, Dar es Salaam, Tanzania; Service de Médecine Interne, Hopital Abass Ndao, Dakar, Senegal; Malariology Unit, Institute of Tropical Medicine, Antwerp, Belgium; Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Disease Control and Elimination, Medical Research Council Unit, Banjul, The Gambia; Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium

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Charles L. Wanga Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso; QGates Clinical Research Organization, Dar es Salaam, Tanzania; African Malaria Network Trust, Dar es Salaam, Tanzania; Service de Médecine Interne, Hopital Abass Ndao, Dakar, Senegal; Malariology Unit, Institute of Tropical Medicine, Antwerp, Belgium; Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Disease Control and Elimination, Medical Research Council Unit, Banjul, The Gambia; Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium

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Innocent Valea Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso; QGates Clinical Research Organization, Dar es Salaam, Tanzania; African Malaria Network Trust, Dar es Salaam, Tanzania; Service de Médecine Interne, Hopital Abass Ndao, Dakar, Senegal; Malariology Unit, Institute of Tropical Medicine, Antwerp, Belgium; Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Disease Control and Elimination, Medical Research Council Unit, Banjul, The Gambia; Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium

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Maimouna Ndour Mbaye Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso; QGates Clinical Research Organization, Dar es Salaam, Tanzania; African Malaria Network Trust, Dar es Salaam, Tanzania; Service de Médecine Interne, Hopital Abass Ndao, Dakar, Senegal; Malariology Unit, Institute of Tropical Medicine, Antwerp, Belgium; Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Disease Control and Elimination, Medical Research Council Unit, Banjul, The Gambia; Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium

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Umberto D'Alessandro Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso; QGates Clinical Research Organization, Dar es Salaam, Tanzania; African Malaria Network Trust, Dar es Salaam, Tanzania; Service de Médecine Interne, Hopital Abass Ndao, Dakar, Senegal; Malariology Unit, Institute of Tropical Medicine, Antwerp, Belgium; Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Disease Control and Elimination, Medical Research Council Unit, Banjul, The Gambia; Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium

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Raffaella M. Ravinetto Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso; QGates Clinical Research Organization, Dar es Salaam, Tanzania; African Malaria Network Trust, Dar es Salaam, Tanzania; Service de Médecine Interne, Hopital Abass Ndao, Dakar, Senegal; Malariology Unit, Institute of Tropical Medicine, Antwerp, Belgium; Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Disease Control and Elimination, Medical Research Council Unit, Banjul, The Gambia; Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, Leuven, Belgium

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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.

Author Notes

* Address correspondence to Raffaella M. Ravinetto, ITM, Nationalestraat 155, Antwerp 2000, Belgium. E-mail: rravinetto@itg.be

Financial support: This course was funded by the Belgian Directorate-General for Development Cooperation (DGD) under the Framework Agreement 3 (FA3) with the Institute of Tropical Medicine, Antwerp (Belgium). The Clinical Trials Unit of the Institute of Tropical Medicine (ITM) is supported by the Department of Economy, Science and Innovation of the Flemish Government.

Authors' addresses: Halidou Tinto and Innocent Valea, Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS)/Centre Muraz, Clinical Research Unit Nanoro, Bobo-Dioulasso, Burkina Faso, E-mails: tintohalidou@yahoo.fr and innocentvalea@yahoo.fr. Ramadhani A. Noor and Charles L. Wanga, Clinical Research Organization, QGates, Dar es Salaam, Tanzania, and African Malaria Network Trust, Dar es Salaam, Tanzania, E-mails: ramanoor@gmail.com and charles.wanga@gmail.com. Maimouna Ndour Mbaye, Hopital Abass Ndao, Service de Médecine Interne, Dakar, Senegal, E-mail: mbayester@gmail.com. Umberto D'Alessandro, Malariology Unit, Institute Tropical Medicine, Antwerp, Belgium, and Disease Control and Elimination, Medical Research Council, Banjul, The Gambia, E-mail: udalessandro@mrc.gm. Raffaella M. Ravinetto, Clinical Trials Unit, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium, and Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium, E-mail: rravinetto@itg.be.

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