6 - An exploration of the philosophy and environment of a South African randomized, double-blind, placebo-controlled trial of Lessertia frutescens
Revue africaine de sociologie,
Vol. 15 No 1 (2011): Revue africaine de sociologie
Résumé
Le présent document décrit la mise en contexte qui a été entreprise lors de la conception et de la réalisation de la première étude pilote sur la sécurité de Sutherlandia (lessertia frutescences), une plante indigène d'Afrique du Sud qui est généralement utilisée, dans le pays, comme médicament traditionnel dans le le traitement d'un certain nombre de maladies, y compris les symptômes associés au vih/sida. il pose la question suivante : les chercheurs qui ont mené l'essai clinique considèrent-ils la justification de manière suffisamment large, approfondie et objective ? il examine comment et pourquoi la mise en contexte a été entreprise et met en évidence les aspects importants de la culture et de l'organisation de l'essai clinique qui pourraient avoir influencéles expériences des participants dans le recrutement et la participation aux essais. L'objectif général est de dresser un tableau de l'environnement dans lequel les essais cliniques ont été proposés et administrés. En effet, des essais cliniques correctement menés sont essentiels aux connaissances dont les organismes de soins de santé ont besoin pour fournir un traitement efficace, sûr et économiquement viable. L'accent est mis sur l'organisation du travail de l'institut qui a mené l'essai clinique, la place du travail d'essai au sein de l' institut et les croyances, attitudes et pratiques du personnel.
Mots-clés
Télécharger la référence bibliographique
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- Abdul-Quarter, A. S., Heckathorn, D. D., Sabin, K. and Saidel T. 2006. Implementation and analysis of respondent driven sampling: Lessons learned from the field. Journal of African health, 83 (6 Suppl), pp. il-5
- Bianchi, A., Bishara, D., Enekwe, P., Frost, B., Kastning, A., and Tiffany, J.2003. Friends inviting friends: Participant-driven recruitment in an HIV prevention research project. community Youth Development Journal 4 (1): 26-31.
- Broadhead, V., Volkanevsky,T., Rydanova, M., et al. 2006. Peer-driven HIV interventions for drug injectors in Russia. First year impact results of a field experiment. international Journal of Drug Policy 17 (5), pp. 379-392.
- Editorial PloS clinical trials e16 .2007.
- Gibson, A., 2010. Negotiating the Search for Diagnosis and Healing of Tuberculosis in Namibia: A Case Study of a Ju/’hoansi soeaking man. African Sociological Review, Vol. 14, 2, pp. 47-61
- Gibson, A. 2011. Science as material practice: clinical trials and the science of Sutherlandia frutescens African Sociological review, Vol. 15 1.
- Glasser, B. G. and Strauss, Anselm. 1965 Awareness of Dying Chicago: Aldine Pub. co Fred Hutchinson Cancer Research Centre, “South Africa Starts Major HIV/AIDS Trial” News-Medical. Net, http://www.newsmedical.net//?id=21812, February, 11, 2007.
- Johnson, Quinton, Syce, James, Nell, Haylene, Rudeen, Kevin and Folk, William, R.,2007. A Randomized, Double-Blind, Placebo-Controlled Trial of lessertia frutescens in Healthy Adults PloS clinical trials, e16 April
- McIntosh, J 1977 communication and Awareness in a cancer ward London: Crom Helm McQuay, Henry., Carroll, Dawn. and Moore, Andrew. 1995. Variation in the placebo effect in randomized trials of analgesics: All is as blind as it seems Pain, 64, pp. 331-5.
- Musavel, M. C., Simon, D. van Stade, and Buchbinder. M. 2005. Community-based participatory research (CBPR) in South Africa: Engaging multiple constituents to shape the research question. Social Science and Medicine 61 (12): 2577-2587
- Oloyede, 2010. Epistemological Issues in the Making of an African Medicine: Sutherlandia lessertia frutescens African Sociological review Vol. 14, no 2, pp. 74-88.
- Reilly, David. 2000.The unblind leading the blind: The Achilles heel of too many trials Journal of Alternative and complementary Medicine 6 (6), pp.479-80.
- Ruggie,Mary.2004. Marginal to Mainstream: Alternative Medicine in America Cambridge: Cambridge University Press.
- Sackett, David and Cook, Deborah, J. 1993. Can we learn anything from small trials? In Kenneth S. Warren and Frederick Mosteller (eds.) Doing More good Than harm: The education of health care interventions (pp. 25-32). New York: BiC/PCP.
- Schulz, K. F. 1997. The case for unbiased research: Randomized clinical trials and the CONSORT? reporting guidelines. Annals of neurology 41, Issue 5, 569-73.
- Tindana, P. O., Singh, J. A., Tracy, C. S., Upshur, R. E., Daar, A. S., Singer, P. A., Frohlich, J., and Lavery, J. V. 2007. Grand challenges in global health: Community engagement in research in developing countries. PloS Med 4 (9): e273.
- UNAIDS, 2007. Ethical considerations in biomedical HIV prevention trials. In Joint united nations
- Programme on hiv/AiDS (unAiDS) and world health organization. Geneva: UNAIDS.
- UNAIDS. 2008. Report on Global AIDS Epidemic, http://data.Unaids.org/pub/GlobalReport/2008/ JC1511_GR08_Executive Summary_en.pdf.
- Virk, Karen Politis. 2009. South Africa Today , Applied clinical trials appliedclinicaltrialsonline.com assessed 6th November.
Les références
Abdul-Quarter, A. S., Heckathorn, D. D., Sabin, K. and Saidel T. 2006. Implementation and analysis of respondent driven sampling: Lessons learned from the field. Journal of African health, 83 (6 Suppl), pp. il-5
Bianchi, A., Bishara, D., Enekwe, P., Frost, B., Kastning, A., and Tiffany, J.2003. Friends inviting friends: Participant-driven recruitment in an HIV prevention research project. community Youth Development Journal 4 (1): 26-31.
Broadhead, V., Volkanevsky,T., Rydanova, M., et al. 2006. Peer-driven HIV interventions for drug injectors in Russia. First year impact results of a field experiment. international Journal of Drug Policy 17 (5), pp. 379-392.
Editorial PloS clinical trials e16 .2007.
Gibson, A., 2010. Negotiating the Search for Diagnosis and Healing of Tuberculosis in Namibia: A Case Study of a Ju/’hoansi soeaking man. African Sociological Review, Vol. 14, 2, pp. 47-61
Gibson, A. 2011. Science as material practice: clinical trials and the science of Sutherlandia frutescens African Sociological review, Vol. 15 1.
Glasser, B. G. and Strauss, Anselm. 1965 Awareness of Dying Chicago: Aldine Pub. co Fred Hutchinson Cancer Research Centre, “South Africa Starts Major HIV/AIDS Trial” News-Medical. Net, http://www.newsmedical.net//?id=21812, February, 11, 2007.
Johnson, Quinton, Syce, James, Nell, Haylene, Rudeen, Kevin and Folk, William, R.,2007. A Randomized, Double-Blind, Placebo-Controlled Trial of lessertia frutescens in Healthy Adults PloS clinical trials, e16 April
McIntosh, J 1977 communication and Awareness in a cancer ward London: Crom Helm McQuay, Henry., Carroll, Dawn. and Moore, Andrew. 1995. Variation in the placebo effect in randomized trials of analgesics: All is as blind as it seems Pain, 64, pp. 331-5.
Musavel, M. C., Simon, D. van Stade, and Buchbinder. M. 2005. Community-based participatory research (CBPR) in South Africa: Engaging multiple constituents to shape the research question. Social Science and Medicine 61 (12): 2577-2587
Oloyede, 2010. Epistemological Issues in the Making of an African Medicine: Sutherlandia lessertia frutescens African Sociological review Vol. 14, no 2, pp. 74-88.
Reilly, David. 2000.The unblind leading the blind: The Achilles heel of too many trials Journal of Alternative and complementary Medicine 6 (6), pp.479-80.
Ruggie,Mary.2004. Marginal to Mainstream: Alternative Medicine in America Cambridge: Cambridge University Press.
Sackett, David and Cook, Deborah, J. 1993. Can we learn anything from small trials? In Kenneth S. Warren and Frederick Mosteller (eds.) Doing More good Than harm: The education of health care interventions (pp. 25-32). New York: BiC/PCP.
Schulz, K. F. 1997. The case for unbiased research: Randomized clinical trials and the CONSORT? reporting guidelines. Annals of neurology 41, Issue 5, 569-73.
Tindana, P. O., Singh, J. A., Tracy, C. S., Upshur, R. E., Daar, A. S., Singer, P. A., Frohlich, J., and Lavery, J. V. 2007. Grand challenges in global health: Community engagement in research in developing countries. PloS Med 4 (9): e273.
UNAIDS, 2007. Ethical considerations in biomedical HIV prevention trials. In Joint united nations
Programme on hiv/AiDS (unAiDS) and world health organization. Geneva: UNAIDS.
UNAIDS. 2008. Report on Global AIDS Epidemic, http://data.Unaids.org/pub/GlobalReport/2008/ JC1511_GR08_Executive Summary_en.pdf.
Virk, Karen Politis. 2009. South Africa Today , Applied clinical trials appliedclinicaltrialsonline.com assessed 6th November.