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Developpement d'une approche de regu...

Maiga, Diadie.

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Developpement d'une approche de regulation des essais cliniques dans un contexte de pays en developpement: Le cas du Mali.

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Developpement d'une approche de regulation des essais cliniques dans un contexte de pays en developpement: Le cas du Mali./
作者:	Maiga, Diadie.
面頁冊數:	226 p.
附註:	Source: Dissertation Abstracts International, Volume: 74-08(E), Section: B.
Contained By:	Dissertation Abstracts International74-08B(E).
標題:	Health Sciences, Public Health. -
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=NR97670
ISBN:	9780494976708

Developpement d'une approche de regulation des essais cliniques dans un contexte de pays en developpement: Le cas du Mali.
Maiga, Diadie.

Developpement d'une approche de regulation des essais cliniques dans un contexte de pays en developpement: Le cas du Mali. - 226 p.

Source: Dissertation Abstracts International, Volume: 74-08(E), Section: B.

Thesis (Ph.D.)--Universite de Montreal (Canada), 2012.

Mali has become an attractive environment for clinical trials. However, the regulatory framework for oversight of these trials is very limited. The country lacks the expertise, infrastructure and resources to fully implement the regulation. This represents a risk to the safety of research participants and the integrity of scientific results. As such, regulation in Mali does not meet international standards such as the Helsinki Declaration or the International Ethical Guidelines of the Council for International Organizations of Medical Sciences (CIOMS), or regulations of industrialized countries like the United States, Canada, or the European Union. To help address this situation, this study examines issues in the regulation of clinical trials in Mali in order to suggest possible solutions and provide recommendations.

ISBN: 9780494976708Subjects--Topical Terms:

1017659
Health Sciences, Public Health.

Developpement d'une approche de regulation des essais cliniques dans un contexte de pays en developpement: Le cas du Mali.
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100 1 $a Maiga, Diadie. $3 2096629
245 1 0 $a Developpement d'une approche de regulation des essais cliniques dans un contexte de pays en developpement: Le cas du Mali.
300 $a 226 p.
500 $a Source: Dissertation Abstracts International, Volume: 74-08(E), Section: B.
500 $a Advisers: Regis Blais; Lise Lamothe; Bryn Williams-Jones.
502 $a Thesis (Ph.D.)--Universite de Montreal (Canada), 2012.
520 $a Mali has become an attractive environment for clinical trials. However, the regulatory framework for oversight of these trials is very limited. The country lacks the expertise, infrastructure and resources to fully implement the regulation. This represents a risk to the safety of research participants and the integrity of scientific results. As such, regulation in Mali does not meet international standards such as the Helsinki Declaration or the International Ethical Guidelines of the Council for International Organizations of Medical Sciences (CIOMS), or regulations of industrialized countries like the United States, Canada, or the European Union. To help address this situation, this study examines issues in the regulation of clinical trials in Mali in order to suggest possible solutions and provide recommendations.
520 $a The study was carried out using qualitative methods; we reviewed official documents and conducted interviews with key stakeholders involved in clinical trials. Neo-institutional theory served as the framework with which to analyse the data. The focus of the neo-institutional approach is to explain the influence of the institutional environment on organizations. According to this approach, the institutional environment is composed of organizational fields such as local and non-local connections, vertical and horizontal ties, cultural and political influences, and technical exchanges.
520 $a The results presented in the first article show that there are many issues that reflect the weakness of the regulatory system in Mali. The coexistence of four scenarios for approving clinical trials illustrates the inconsistency of current mechanisms. As well as the absence of inspection, there is also limited intervention on the part of the government in regulatory oversight. These issues arise from a double influence on the regulatory authorities and ethics committees. First, they are influenced by an institutional environment that is subject to regulatory, cognitive and normative pressures. Second, researchers operate as institutional entrepreneurs by occupying a central role in the field of regulation, and so influence the oversight bodies.
520 $a In a second article, our study provides a detailed analysis of the factors influencing the regulation of clinical trials, synthesized into five groups that are divided into two spheres of influence. The analysis shows how these factors negatively influence regulation, specifically: 1) there is an incomplete structuring of the regulatory field due to a low degree of interaction, a lack of coordination structure, mutual information and consciousness in the constitution of interdependencies, and 2) the relative positions of the actors involved in the construction of the regulatory field manifests in a weak authority of the government and the domination of research groups..
520 $a Finally, in a third article we propose some mechanisms that, if implemented, could improve the regulation of clinical trials in Mali. These mechanisms are presented, with reference to the theoretical framework, as three channels of influence, namely regulatory, normative and cultural-cognitive.
520 $a In conclusion, the study sends a strong signal for the need for appropriate regulation of clinical trials in Mali. It shows that the most fundamental problems in regulation result from a need for restructuring of the organizational field and a strengthening the position of government.
520 $a Key words: Clinical trials, human subjects, regulation, governance, neo-institutional theory, research ethics, ethics committees, national regulatory authority, influencing factors, mechanisms, developing countries, Africa, Mali.
590 $a School code: 0992.
650 4 $a Health Sciences, Public Health. $3 1017659
650 4 $a Health Sciences, Medical Ethics. $3 1669715
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710 2 $a Universite de Montreal (Canada). $b Health Administration. $3 2096630
773 0 $t Dissertation Abstracts International $g 74-08B(E).
790 $a 0992
791 $a Ph.D.
792 $a 2012
793 $a French
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=NR97670