Développement d’une approche de régulation des essais cliniques dans un contexte de pays en développement : le cas du Mali

Le Mali est devenu un milieu attractif pour les essais cliniques. Cependant, le cadre de réglementation pour leur surveillance y est très limité. Le pays manque de l’expertise, de l’infrastructure et des ressources nécessaires pour mettre en œuvre pleinement la régulation. Ceci représente un risque pour la sécurité des sujets de recherche et l’intégrité des résultats scientifiques. Il ne permet pas non plus de s’aligner sur les normes internationales en vigueur, telles que la déclaration d’Helsinki, les directives éthiques internationales du Conseil des organisations internationales des sciences médicales (CIOMS) ou les réglementations de pays industrialisés comme les États-Unis, le Canada ou l’Union Européenne. Pour améliorer la situation, la présente étude vise à comprendre les enjeux de la régulation des essais cliniques au Mali afin de suggérer des pistes de solutions et des recommandations. L’étude a été réalisée à l’aide de méthodes qualitatives, soit l’examen de documents officiels et des entrevues semi-dirigées avec les principaux acteurs impliqués dans les essais cliniques. La théorie néo-institutionnelle a servi de toile de fond à l’analyse des données. L’approche néo-institutionnelle consiste à expliquer l’influence de l’environnement sur les organisations. Selon cette approche, l’environnement s’assimile à des champs organisationnels incluant les connexions locales ou non, les liens horizontaux et verticaux, les influences culturelles et politiques ainsi que les échanges techniques. Les résultats présentés dans un premier article montrent l’existence de nombreux enjeux reflétant la carence du système de régulation au Mali. La coexistence de quatre scénarios d’approbation des essais cliniques illustre bien l’inconsistance des mécanismes. Tout comme l’absence d’inspection, l’inconsistance des mécanismes traduit également l’intervention limitée des pouvoirs publics dans la surveillance réglementaire. Ces enjeux résultent d’une double influence subie par les autorités réglementaires et les comités d’éthique. Ceux-ci sont, d’une part, influencés par l’environnement institutionnel sous pressions réglementaires, cognitives et normatives. D’autre part, les pouvoirs publics subissent l’influence des chercheurs qui opèrent comme des entrepreneurs institutionnels en occupant un rôle central dans le champ de la régulation. Dans un second article, l’étude propose une analyse détaillée des facteurs influençant la régulation des essais cliniques. Ces facteurs sont synthétisés en cinq groupes répartis entre deux sphères d’influence. L’analyse montre combien ces facteurs influencent négativement la régulation, notamment : 1) la structuration inachevée du champ de régulation due à un faible degré d’interactions, une absence de structure de coordination, d’informations mutuelles et de conscience dans la constitution des interdépendances; et 2) les positions relatives des acteurs impliqués dans la construction du champ de régulation se manifestant par une faible autorité des pouvoirs publics et l’ascendance des groupes de recherche. Enfin, dans un troisième article nous proposons quelques mécanismes qui, s’ils sont mis en œuvre, pourraient améliorer la régulation des essais cliniques au Mali. Ces mécanismes sont présentés, en référence au cadre théorique, sous trois types de vecteurs d’influence, notamment réglementaires, normatifs et cognitifs-culturels. En guise de conclusion, l’étude envoie un signal fort pour la nécessité d’une régulation appropriée des essais cliniques au Mali. Elle montre que la plupart des problèmes de fond en matière de régulation relèvent d’un besoin de restructuration du champ organisationnel et de renforcement de la position des pouvoirs publics.

Measuring and evaluating quality of care in referral maternities in Mali and Senegal in the context of overlapping interventions

Dans cette thèse, nous décrivons les résultats d’un projet de recherche visant à mesurer et évaluer la qualité des soins obstétricaux des hôpitaux de référence au Mali et au Sénégal. Dans ces pays, la mortalité maternelle hospitalière est élevée et est liée en partie à la pratique médicale inadéquate. Cette recherche a été réalisée dans le cadre de l’étude QUARITE, un essai randomisé en grappe évaluant l’efficacité du programme GESTA International visant à réduire la mortalité maternelle hospitalière. GESTA a été mis en œuvre entre 2008 et 2010 et consistait en la formation des professionnels de santé et en la revue des cas de décès maternels. En parallèle de QUARITE, les programmes de prévention de la transmission du VIH de la mère à l’enfant (PTME) ont été mis à l’échelle à travers les pays. Ces derniers ayant également la capacité d’augmenter la qualité des soins obstétricaux, nous avons donc évalué les effets des deux programmes (GESTA et PTME) sur la qualité des soins. Dans un premier temps, à l’aide d’une recension des écrits nous avons évalué la capacité d’un audit clinique basé sur des critères à mesurer la qualité des soins obstétricaux. Cet audit vérifiait si l’offre des soins avait respecté les critères cliniques définissant la meilleure prise en charge selon l’évidence scientifique et l’avis des experts. Nous avons démontré que cet outil est largement utilisé dans les pays à faibles et moyens revenus, malgré le peu d’évidence sur sa validité (article 1). Dans un deuxième temps, nous avons développé un audit clinique basé sur des critères qui s’applique au contexte ouest-africain et qui a été approuvé par des experts-obstétriciens nationaux et internationaux. À partir des dossiers obstétricaux, les actes médicaux posés pendant le travail et l’accouchement ont été évalués à l‘aide de cet instrument. La qualité des soins a été estimée sous forme de pourcentage de critères atteints. Appliqué dans différents contextes et par différents auditeurs, nous avons démontré que notre instrument est fiable et valide (article 3). Néanmoins, l’expérience de l’audit nous a amenés à nous questionner sur le mauvais remplissage des dossiers médicaux et ses conséquences sur la qualité des soins (article 2). Dans un troisième temps, l’outil a été appliqué à large échelle pour évaluer les effets de l’intervention GESTA (article 4). Nous avons mené une révision de plus de 800 dossiers obstétricaux dans 32 hôpitaux de référence (16 bénéficiaires de l’intervention et 16 non-bénéficiaires). Grâce à cet audit clinique, nous avons démontré que le programme GESTA contribue à l’amélioration de la qualité des soins, spécifiquement l’examen clinique lors de l’admission et le suivi après l’accouchement. Dernièrement, nous avons utilisé cet instrument afin d’évaluer les effets des programmes de PTME sur la qualité des soins obstétricaux (article 5). Notre travail a documenté que seulement certaines composantes du programme de PTME améliorent la qualité des soins telles que la formation des professionnels et les services complémentaires en nutrition. En conclusion, cette recherche a identifié plusieurs pistes d’intervention pour améliorer la qualité des soins obstétricaux en Afrique de l’Ouest.

Effect of management strategies on the performance of ruminant livestock production systems and the safety of plant and animal products in the city of Sikasso, Mali

The regional population growth in West Africa, and especially its urban centers, will bring about new and critical challenges for urban development policy, especially in terms of ensuring food security and providing employment for the growing population. (Peri-) urban livestock and vegetable production systems, which can contribute significantly to these endeavours, are limited by various constraints, amongst them limited access to expensive production factors and their (in)efficient use. To achieve sustainable production systems with low consumer health risks, that can meet the urban increased demand, this doctoral thesis determined nutrient use efficiencies in representative (peri-) urban livestock production systems in three West African cities, and investigated potential health risks for consumers ensuing from there. The field study, which was conducted during July 2007 to December 2009, undertook a comparative analysis of (peri-) urban livestock production strategies across 210 livestock keeping households (HH) in the three West African cities of Kano/Nigeria (84 HH), Bobo Dioulasso/Burkina Faso (63 HH) and Sikasso/Mali (63 HH). These livestock enterprises were belonging to the following three farm types: commercial gardening plus field crops and livestock (cGCL; 88 HH), commercial livestock plus subsistence field cropping (cLsC; 109 HH) and commercial gardening plus semi-commercial livestock (cGscL; 13 HH) which had been classified in a preceding study; they represented the diversity of (peri-) urban livestock production systems in West Africa. In the study on the efficiency of ruminant livestock production, lactating cowsand sheep herd units were differentiated based on whether feed supplements were offered to the animals at the homestead (Go: grazing only; Gsf: mainly grazing plus some supplement feeding). Inflows and outflows of nutrients were quantified in these herds during 18 months, and the effects of seasonal variations in nutrient availability on animals’ productivity and reproductive performance was determined in Sikasso. To assess the safety of animal products and vegetables, contamination sources of irrigated lettuce and milk with microbiological contaminants, and of tomato and cabbage with pesticide residues in (peri-) urban agriculture systems of Bobo Dioulasso and Sikasso were characterized at three occasions in 2009. Samples of irrigation water, organic fertilizer and ix lettuce were collected in 6 gardens, and samples of cabbage and tomato in 12 gardens; raw and curdled milk were sampled in 6 dairy herds. Information on health risks for consumers of such foodstuffs was obtained from 11 health centers in Sikasso. In (peri-) urban livestock production systems, sheep and goats dominated (P<0.001) in Kano compared to Bobo Dioulasso and Sikasso, while cattle and poultry were more frequent (P<0.001) in Bobo Dioulasso and Sikasso than in Kano. Across cities, ruminant feeding relied on grazing and homestead supplementation with fresh grasses, crop residues, cereal brans and cotton seed cake; cereal grains and brans were the major ingredients of poultry feeds. There was little association of gardens and livestock; likewise field cropping and livestock were rarely integrated. No relation existed between the education of the HH head and the adoption of improved management practices (P>0.05), but the proportion of HH heads with a long-term experience in (peri-) urban agriculture was higher in Kano and in Bobo Dioulasso than in Sikasso (P<0.001). Cattle and sheep fetched highest market prices in Kano; unit prices for goats and chicken were highest in Sikasso. Animal inflow, outflow and dairy herd growth rates were significantly higher (P<0.05) in the Gsf than in the Go cattle herds. Maize bran and cottonseed expeller were the main feeds offered to Gsf cows as dry-season supplement, while Gsf sheep received maize bran, fresh grasses and cowpea pods. The short periodic transhumance of Go dairy cows help them maintaining their live weight, whereas Gsf cows lost weight during the dry season despite supplement feeding at a rate of 1506 g dry matter per cow and day, resulting in low productivity and reproductive performance. The daily live weight gains of calves and lambs, respectively, were low and not significantly different between the Go and the Gsf system. However, the average live weight gains of lambs were significantly higher in the dry season (P<0.05) than in the rainy season because of the high pressure of gastrointestinal parasites and of Trypanosoma sp. In consequence, 47% of the sheep leaving the Go and Gsf herds died due to diseases during the study period. Thermo-tolerant coliforms and Escherichia coli contamination levels of irrigation water significantly exceeded WHO recommendations for the unrestricted irrigation of vegetables consumed raw. Microbial contamination levels of lettuce at the farm gate and the market place in Bobo Dioulasso and at the farm gate in Sikasso were higher than at the market place in Sikasso (P<0.05). Pesticide residues were detected in only one cabbage and one tomato sample and were below the maximum residue limit for consumption. Counts of thermo-tolerant coliforms and Escherichia coli were higher in curdled than in raw milk (P<0.05). From 2006 to x 2009, cases of diarrhea/vomiting and typhoid fever had increased by 11% and 48%, respectively, in Sikasso. For ensuring economically successful and ecologically viable (peri-) urban livestock husbandry and food safety of (peri-) urban foodstuffs of animal and plant origin, the dissemination and adoption of improved feeding practices, livestock healthcare and dung management are key. In addition, measures fostering the safety of animal products and vegetables including the appropriate use of wastewater in (peri-) urban agriculture, restriction to approve vegetable pesticides and the respect of their latency periods, and passing and enforcement of safety laws is required. Finally, the incorporation of environmentally sound (peri-) urban agriculture in urban planning by policy makers, public and private extension agencies and the urban farmers themselves is of utmost importance. To enable an efficient (peri-) urban livestock production in the future, research should concentrate on cost-effective feeding systems that allow meeting the animals’ requirement for production and reproduction. Thereby focus should be laid on the use of crop-residues and leguminous forages. The improvement of the milk production potential through crossbreeding of local cattle breeds with exotic breeds known for their high milk yield might be an accompanying option, but it needs careful supervision to prevent the loss of the local trypanotolerant purebreds.

El apoyo de Argelia a la independencia del grupo étnico saharawi como fachada para el alcance de su interés geopolítico (2008-2012)

El objetivo principal del presente estudio de caso es determinar el interés geopolítico que impulsa a Argelia a apoyar las intenciones de independencia de la República Árabe Saharawi Democrática (RASD). Como consecuencia del proceso de descolonización del Sahara Occidental que ha sido negado por las potencias colonizadoras que allí se encontraban y por Marruecos, país que reivindica su posesión del territorio; Argelia se ha apadrinado de la causa saharawi mediante la transferencia de armamento y envío de alimentos al Frente Polisario de Liberación y ha logrado que 26 países de la Unión Africana reconozcan la existencia de la RASD. Sin embargo, detrás de la vocación argelina sobre la promoción al respeto del principio de autodeterminación se esconden una serie de intereses geopolíticos, comerciales y de seguridad que pueden ser satisfechos con un Sahara Occidental independiente.

Análisis de la ayuda oficial al desarrollo. estudio de caso: programa conjunto de UNICEF y UNFPA sobre la mutilación genital femenina en Kenia (2008-2012)

El interés de este estudio de caso es analizar el Programa Conjunto de UNFPA y UNICEF sobre MGF/E en Kenia bajo la luz de los postulados poscolonialistas. Partiendo de la idea de que la MGF es una manifestación de las desigualdades de género, se argumenta que el PC reproduce la imagen de la mujer keniana como una víctima del poder masculino. A partir de esta imagen se deslegitima el orden cultural de los grupos que siguen esta tradición, afectando las lógicas de unidad y cohesión de la sociedad. El análisis de este tipo de dinámicas permite comprender mejor los procesos de intervención de las organizaciones internacionales sobre las estructuras sociales de actores frágiles del sistema internacional.

'Agricultural poverty' and the expansion of artisanal mining in sub-Saharan Africa: Experiences from southwest Mali and southeast Ghana

Why do people engage in artisanal and small-scale mining (ASM) – labour-intensive mineral extraction and processing activity – across sub-Saharan Africa? This paper argues that ‘agricultural poverty’, or hardship induced by an over-dependency on farming for survival, has fuelled the recent rapid expansion of ASM operations throughout the region. The diminished viability of smallholder farming in an era of globalization and overreliance on rain-fed crop production restricted by seasonality has led hundreds of thousands of rural African families to ‘branch out’ into ASM, a move made to secure supplementary incomes. Experiences from Komana West in Southwest Mali and East Akim District in Southeast Ghana are drawn upon to illustrate how a movement into the ASM economy has impacted farm families, economically, in many rural stretches of sub-Saharan Africa.

The Jua Kali and the Mali-Mali: the informal/formal nexus amongst Kenyan micro enterprises

This paper presents a preliminary exploration of the informal/formal economy nexus and entrepreneurial processes amongst a sample of Kenyan roadside vendors who mostly operate in the informal economy. Using semi-structured interviews, data was collected from sixty street vendors across Kenya. In particular the paper focuses on the relationship between the informal and formal economy and the factors that promote formality amongst micro and small enterprises in developing countries. The paper presents a conceptualization of a potential segmentation of the informal economy, considering the implications of this in terms of base of the pyramid initiatives and the promotion of development through enterprise.

Development Aid to Water Management in Mali: The Actors, ‘Global’ Paradigms, and ‘Local’ Translations

Development aid involves a complex network of numerous and extremely heterogeneous actors. Nevertheless, all actors seem to speak the same ‘development jargon’ and to display a congruence that extends from the donor over the professional consultant to the village chief. And although the ideas about what counts as ‘good’ and ‘bad’ aid have constantly changed over time —with new paradigms and policies sprouting every few years— the apparent congruence between actors more or less remains unchanged. How can this be explained? Is it a strategy of all actors to get into the pocket of the donor, or are the social dynamics in development aid more complex? When a new development paradigm appears, where does it come from and how does it gain support? Is this support really homogeneous? To answer the questions, a multi-sited ethnography was conducted in the sector of water-related development aid, with a focus on 3 paradigms that are currently hegemonic in this sector: Integrated Water Resources Management, Capacity Building, and Adaptation to Climate Change. The sites of inquiry were: the headquarters of a multilateral organization, the headquarters of a development NGO, and the Inner Niger Delta in Mali. The research shows that paradigm shifts do not happen overnight but that new paradigms have long lines of descent. Moreover, they require a lot of work from actors in order to become hegemonic; the actors need to create a tight network of support. Each actor, however, interprets the paradigms in a slightly different way, depending on the position in the network. They implant their own interests in their interpretation of the paradigm (the actors ‘translate’ their interests), regardless of whether they constitute the donor, a mediator, or the aid recipient. These translations are necessary to cement and reproduce the network.

Ein "Parlamentsheer" ohne "preußische Erbstücke"? Der zivil-militärische Konflikt um die Kaiserlichen Schutztruppen

Die Kaiserlichen Schutztruppen waren im Unterschied zur Preußischen Armee und zur Marine der Kaiserlichen Kommandogewalt weitgehend entzogen. Dieser Bruch mit der konservativen Militärpolitik wurde dadurch ermöglicht, dass die politischen und militärischen Eliten in der Gründungsphase der Schutzgebiete und -truppen den absoluten Primat auf die kontinentale Sicherheit legten und ein ernsthaftes Engagement der etablierten Streitkräfte an der Peripherie entschieden ablehnten. Den Führungsspitzen der Armee und der Marine missfiel es aber grundsätzlich, dass die leitenden Stellen der zivilen Kolonialbehörden militärische Kernkompetenzen ausübten. Durch die ganze Institutionsgeschichte der Schutztruppe hindurch sollten sie daher in einem Konflikt mit den Kolonialbehörden über die konstitutionelle Stellung dieser militärischen Formation stehen. Zwar blieb die zivile Kontrolle über das Militär in den Kolonien auf dem Papier erhalten, sie konnte in ausgeprägten Bedrohungslagen dem Druck der Militärs jedoch nicht standhalten. So ignorierte der Kommandeur der ostafrikanischen Schutztruppe, von Lettow-Vorbeck, alle verfassungsrechtlichen Hindernisse und übernahm die militärische Macht im Schutzgebiet. Obwohl es sich dabei letztlich um einen Militärputsch handelt, war Lettow-Vorbecks Handlungsweise zutiefst in der preußischen Militärtradition verankert und machte es möglich, dass der Kommandeur zum Kriegshelden wurde.

The Mirage of the State: Why the West has failed in Afghanistan, Iraq, Libya, Mali and Central African Republic? Jean Monnet/Robert Schuman Paper Series Vol. 14 No. 15, July 2014

The state still matters. However, the members of the Euro-Atlantic community may be misinterpreting this crucial baseline prior launching their military interventions since 2001. The latest violence and collapse of the state of Iraq after the invasion of Northern Iraq by a radical Sunni Muslim terrorist group, so-called Islamic State of Iraq and Syria (ISIS), demonstrate once again the centrality and requirement of a functioning state in order to maintain violent forces to disrupt domestic and regional stability. Since 2001, the US and its European allies have waged wars against failed-states in order to increase this security and national interests, and then have been involved in some type of state-building.1 This has been the case in Afghanistan, Iraq, Libya, Mali, and Central African Republic (CAR). France went into Mali (2012) and CAR (2013), which preceded two European Union military and civilian Common Security and Defense Policy missions (CSDP), in order to avoid the collapse of these two states. The threat of the collapse of both states was a concern for the members of the Euro-Atlantic community as it could have spread to the region and causing even greater instabilities. In Mali, the country was under radical Islamic pressures coming from the North after the collapse of Libya ensuing the 2011 Western intervention, while in CAR it was mainly an ethno-religious crisis. Failed states are a real concern, as they can rapidly become training grounds for radical groups and permitting all types of smuggling and trafficking.2 In Mali, France wanted to protect its large French population and avoid the fall of Mali in the hands of radical Islamic groups directly or indirectly linked to Al-Qaeda. A fallen Mali could have destabilized the region of the Sahel and ultimately affected the stability of Southern European borders. France wanted to avoid the development of a safe haven across the Sahel where movements of people and goods are uncontrolled and illegal.3 Since the end of the Cold War, Western powers have been involved in stabilizing neighborhoods and regions, like the Balkans, Africa, and Middle East, which at the exceptions of the Balkans, have led to failed policies. 9/11 changes everything. The US, under President George W. Bush, started to wage war against terrorism and all states link to it. This started a period of continuous Western interventions in this post-9/11 era in Afghanistan, Iraq, Libya, Mali and CAR. If history has demonstrated one thing, the members of the Euro-Atlantic community are struggling and will continue to struggle to stabilize Afghanistan, Iraq, Libya, Mali and Central African Republic (CAR) for one simple reason: no clear endgame. Is it the creation of a state à la Westphalian in order to permit these states to operate as the sole guarantor of security? Or is the reestablishment of status quo in these countries permitting to exit and end Western operations? This article seeks to analyze Western interventions in these five countries in order to reflect on the concept of the state and the erroneous starting point for each intervention.4 In the first part, the political status of each country is analyzed in order to understand the internal and regional crisis. In a second time, the concept of the state, framed into the Buzanian trinity, is discussed and applied to the cases. In the last part the European and American civilian-military doctrines are examined in accordance with their latest military interventions and in their broader spectrum.