Journal of Pharmacovigilance

Role of clinical trials: In Lebanon

2^nd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

November 18-19, 2013 Hilton San Antonio Airport, TX, USA

Fadi Abou-Mrad

Accepted Abstracts: J Pharmacovigilance

Abstract:

This study is considered the first to analyze the situation in Lebanon concerning the ethical frame of therapeutic trials in order to compare to the two largest groups of industrials and developing countries. The national survey was held in 144 hospitals working in the Lebanese environment characterized by a plurality of communities. Three methodological tools were used: a questionnaire (IRB, pharmaceutical companies, patients), direct and semi-direct interviews. The analysis about the ethical quality of IRB works legitimacy was developed according to Berdeu chart. There is heterogeneity in the practices of essential definitions regarding biomedical research and its limitations. IRB regulations are rather permissive to researchers and industrial promoters. The future of research and the protection of concerned participants are at stake. The scientific expertise within IRBs, and the criteria applied in determining ethical opinions are major concerns. The absence of a pharmacovigilance system or of a competent authority in health safety increases the seriousness of the current situation. The field is now open to industrial promoters, and the right goal of clinical trials is under questioning. The country has to decide to which extent it will accept and support clinical and scientific investigations implying citizens? participation. This mission is essential and necessary to avoid transforming research into oppression and manipulation of the human being.