Authors:
, , , , , , , , , , , , , , , , , and
ProCite
RefWorks
Reference Manager
BibTeX
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-
1.
Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T, Fineberg H, Garcia P, Ke Y, Kelley P, Kistnasamy B, Meleis A, Naylor D, Pablos-Mendez A, Reddy S, Scrimshaw S, Sepulveda J, Serwadda D, Zurayk H, 2010. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world. Lancet 376: 1923–1958.
-
2.
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA, 2009. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 360: 816–823.
-
3.
European Group on Ethics in Science and New Technologies to the European Commission, 2003. Opinion on the Ethical Aspects of Clinical Research in Developing Countries. Opinion N° 17, 4th February 2003. Luxembourg: Office for Official Publications of the European Communities 2003.
-
4.
Levinson DR, 2010. Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials. US Department of Health and Human Services, Office of Inspector General. 2010, OEI-01-08-00510. Washington, DC: Department of Health and Human Services.
-
5.
European Medicines Agency, 2012. Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorisation Applications to the EU Regulatory Authorities. 16 April 2012. EMA/121340/2011. London, UK: European Medicines Agency.
-
6.
Mgone CS, Salami W, 2009. EDCTP: a genuine North-South partnership. Trop Med Int Health 14: 1327–1328.
-
7.
Dolgin E, 2010. African networks launch to boost clinical trial capacity. Nat Med 16: 8.
-
8.
Nuremberg Military Tribunal, 1996. The Nuremberg Code. JAMA 276: 1691.
-
9.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979. Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. April 18, 1979. Washington, DC: Department of Health, Education, and Welfare. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.
-
10.
2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in Collaboration with the World Health Organization (WHO). CIOMS, Geneva, 2002.
-
11.
World Medical Association Declaration of Helsinki, 2011. Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and Last Amended by the 59th WMA General Assembly, Seoul, October 2008. Ferney-Voltaire, France: WMA.
-
12.
World Health Organization, 1995. Technical Report Series No 850. Annex 3, Guidelines for GCP for Trials on Pharmaceutical Products. Geneva: WHO.
-
13.
World Health Organization, 2002. World Health Organization Handbook for Good Clinical Research Practices. Guidance for Implementation. Geneva: WHO.
-
14.
1996. International Conference of Harmonization. Tripartite Guideline for Good Clinical Practices E6 (R1), 10th June 1996. Geneva: ICH.
-
15.
Angell M, 1997. The ethics of clinical research in the third world. N Engl J Med 337: 847–849.
-
16.
Nuffield Council on Bioethics, 1999. The Ethics of Clinical Research in Developing Countries. London, UK: Nuffield Council on Bioethics.
-
17.
Nuffield Council on Bioethics, 2002. The Ethics of Research Related to Healthcare in Developing Countries. London, UK: Nuffield Council on Bioethics.
-
18.
Lancet, 2007. Strengthening clinical research in India. Lancet 369: 1233.
-
19.
World Health Organization, 2008. Clinical trials in India: ethical concerns. Transnational drug companies are moving their clinical trials business to India, giving a new urgency to clinical trials registry reform there. Patralekha Chatterjee reports. Bull World Health Organ 86: 58.
-
20.
Emanuel EJ, Wendler D, Killen J, Grady C, 2004. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 189: 930–937.
-
21.
Heimburger DC, Carothers CL, Gardner P, Primack A, Warner TL, Vermund SH, 2011. Nurturing the global workforce in clinical research: the National Institutes of Health Fogarty International Clinical Scholars and Fellows Program. Am J Trop Med Hyg 85: 971–978.
-
22.
Ravinetto R, Tinto H, Rouamba N, Talisuna A, Adoke Y, Kadima Ebeja A, Maketa V, Grietens KP, Buve A, Crawley F, 2010. Health research: the challenges related to ethical review and informed consent in developing countries. Italian Journal of Tropical Medicine 15: 15–20.
-
23.
Ravinetto R, Buvé A, Halidou T, Lutumba P, Talisuna A, Juffrie M, D'Alessandro U, Boelaert M, 2011. Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership? Trop Med Int Health 16: 527–530.
-
24.
Paré Toé L, 2011. Informed Consent and Decision-Making in Vulnerable Populations. The Findings of a Multi-Methods Study Carried Out in Burkina Faso. Personal Communication at the 6th EDCTP Forum, Addis Ababa, October 2011. Available at: http://globalhealthtrials.tghn.org/site_media/media/articles/2011_ITM__Satellite_EDCTP_Forum_.pdf. Accessed January 17, 2013.
-
25.
van Loen H, Thiongo M, Battara A, Kalonji H, Meester R, Mwakazanga D, Ouedraogo S, Smedley J, Sopheak S, Woukeu A, Gondol G, Ravinetto R, Claeys Y, 2011. Data Management in Non-Commercial North-South Collaborative Clinical Research: Lessons Learned from Some EDCTP Trials. Abstract Accepted as Oral Communication at the Sixth EDCTP Forum, Addis Ababa. The Hague, The Netherlands: EDCTP. Available at: http://www.edctpforum.org/programme/. Accessed January 17, 2013.
-
26.
Claeys Y, Ouedraogo S, Battara A, Kalonji H, Meester R, Mwakazanga D, Smedley J, Sopheak S, Thiongo M, Woukeu A, Gondol G, Ravinetto R, van Loen H, 2011. Data Management in Tropical Medicine: A Call for Uniformity. Tropical Medicine & International Health Volume 16, Supplement 1, October 2011 Abstracts of the 7th European Congress on Tropical Medicine and International Health.
-
27.
Chilengi R, Ogetii G, Lang T, 2010. A sensible approach to monitoring trials: finding effective solutions in-house. WebmedCentral CLINICAL TRIALS 1: WMC00891.
-
28.
Lang T, Cheah PY, White NJ, 2011. Clinical research: time for sensible global guidelines. Lancet 377: 1553–1555.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1373 | 1281 | 265 |
| Full Text Views | 348 | 11 | 0 |
| PDF Downloads | 107 | 11 | 0 |
Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice
Halidou Tinto
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
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
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
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
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
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
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
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.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T, Fineberg H, Garcia P, Ke Y, Kelley P, Kistnasamy B, Meleis A, Naylor D, Pablos-Mendez A, Reddy S, Scrimshaw S, Sepulveda J, Serwadda D, Zurayk H, 2010. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world. Lancet 376: 1923–1958.
-
2.
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA, 2009. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 360: 816–823.
-
3.
European Group on Ethics in Science and New Technologies to the European Commission, 2003. Opinion on the Ethical Aspects of Clinical Research in Developing Countries. Opinion N° 17, 4th February 2003. Luxembourg: Office for Official Publications of the European Communities 2003.
-
4.
Levinson DR, 2010. Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials. US Department of Health and Human Services, Office of Inspector General. 2010, OEI-01-08-00510. Washington, DC: Department of Health and Human Services.
-
5.
European Medicines Agency, 2012. Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorisation Applications to the EU Regulatory Authorities. 16 April 2012. EMA/121340/2011. London, UK: European Medicines Agency.
-
6.
Mgone CS, Salami W, 2009. EDCTP: a genuine North-South partnership. Trop Med Int Health 14: 1327–1328.
-
7.
Dolgin E, 2010. African networks launch to boost clinical trial capacity. Nat Med 16: 8.
-
8.
Nuremberg Military Tribunal, 1996. The Nuremberg Code. JAMA 276: 1691.
-
9.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979. Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. April 18, 1979. Washington, DC: Department of Health, Education, and Welfare. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.
-
10.
2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in Collaboration with the World Health Organization (WHO). CIOMS, Geneva, 2002.
-
11.
World Medical Association Declaration of Helsinki, 2011. Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and Last Amended by the 59th WMA General Assembly, Seoul, October 2008. Ferney-Voltaire, France: WMA.
-
12.
World Health Organization, 1995. Technical Report Series No 850. Annex 3, Guidelines for GCP for Trials on Pharmaceutical Products. Geneva: WHO.
-
13.
World Health Organization, 2002. World Health Organization Handbook for Good Clinical Research Practices. Guidance for Implementation. Geneva: WHO.
-
14.
1996. International Conference of Harmonization. Tripartite Guideline for Good Clinical Practices E6 (R1), 10th June 1996. Geneva: ICH.
-
15.
Angell M, 1997. The ethics of clinical research in the third world. N Engl J Med 337: 847–849.
-
16.
Nuffield Council on Bioethics, 1999. The Ethics of Clinical Research in Developing Countries. London, UK: Nuffield Council on Bioethics.
-
17.
Nuffield Council on Bioethics, 2002. The Ethics of Research Related to Healthcare in Developing Countries. London, UK: Nuffield Council on Bioethics.
-
18.
Lancet, 2007. Strengthening clinical research in India. Lancet 369: 1233.
-
19.
World Health Organization, 2008. Clinical trials in India: ethical concerns. Transnational drug companies are moving their clinical trials business to India, giving a new urgency to clinical trials registry reform there. Patralekha Chatterjee reports. Bull World Health Organ 86: 58.
-
20.
Emanuel EJ, Wendler D, Killen J, Grady C, 2004. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 189: 930–937.
-
21.
Heimburger DC, Carothers CL, Gardner P, Primack A, Warner TL, Vermund SH, 2011. Nurturing the global workforce in clinical research: the National Institutes of Health Fogarty International Clinical Scholars and Fellows Program. Am J Trop Med Hyg 85: 971–978.
-
22.
Ravinetto R, Tinto H, Rouamba N, Talisuna A, Adoke Y, Kadima Ebeja A, Maketa V, Grietens KP, Buve A, Crawley F, 2010. Health research: the challenges related to ethical review and informed consent in developing countries. Italian Journal of Tropical Medicine 15: 15–20.
-
23.
Ravinetto R, Buvé A, Halidou T, Lutumba P, Talisuna A, Juffrie M, D'Alessandro U, Boelaert M, 2011. Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership? Trop Med Int Health 16: 527–530.
-
24.
Paré Toé L, 2011. Informed Consent and Decision-Making in Vulnerable Populations. The Findings of a Multi-Methods Study Carried Out in Burkina Faso. Personal Communication at the 6th EDCTP Forum, Addis Ababa, October 2011. Available at: http://globalhealthtrials.tghn.org/site_media/media/articles/2011_ITM__Satellite_EDCTP_Forum_.pdf. Accessed January 17, 2013.
-
25.
van Loen H, Thiongo M, Battara A, Kalonji H, Meester R, Mwakazanga D, Ouedraogo S, Smedley J, Sopheak S, Woukeu A, Gondol G, Ravinetto R, Claeys Y, 2011. Data Management in Non-Commercial North-South Collaborative Clinical Research: Lessons Learned from Some EDCTP Trials. Abstract Accepted as Oral Communication at the Sixth EDCTP Forum, Addis Ababa. The Hague, The Netherlands: EDCTP. Available at: http://www.edctpforum.org/programme/. Accessed January 17, 2013.
-
26.
Claeys Y, Ouedraogo S, Battara A, Kalonji H, Meester R, Mwakazanga D, Smedley J, Sopheak S, Thiongo M, Woukeu A, Gondol G, Ravinetto R, van Loen H, 2011. Data Management in Tropical Medicine: A Call for Uniformity. Tropical Medicine & International Health Volume 16, Supplement 1, October 2011 Abstracts of the 7th European Congress on Tropical Medicine and International Health.
-
27.
Chilengi R, Ogetii G, Lang T, 2010. A sensible approach to monitoring trials: finding effective solutions in-house. WebmedCentral CLINICAL TRIALS 1: WMC00891.
-
28.
Lang T, Cheah PY, White NJ, 2011. Clinical research: time for sensible global guidelines. Lancet 377: 1553–1555.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1373 | 1281 | 265 |
| Full Text Views | 348 | 11 | 0 |
| PDF Downloads | 107 | 11 | 0 |