[Critical approach to clinical trials: difficulties of such research in Lebanon]. / Approche critique des essais thérapeutiques : difficultés de ce type de recherche au Liban.

Clinical trials represent new steps in the progress of knowledge. Yet in spite of all the norms, guidelines and good clinical practices established since 1947, trials are still being published which seem to be, but in fact are not, well-conducted. Experts in planning and analyzing trial results have determined the factors that may affect clinical investigations at different phases. Among articles published over the last 30 years selected from Medline, one-third were biased. These biased articles were cited 2034 times. Clinical trials are designed to improve the treatment of particular diseases and to reduce mortality and morbidity. Nevertheless, other factors still appear to have an essential influence on the way clinical trials are conducted. It is surprising to see how often trials conclude that the drug of the pharmaceutical company initiating the study or funding it has the same efficiency, and sometimes is more efficient, than the drug it is being judged against. Perhaps, journals should objectively describe clinical trial protocols before publishing their results. Poor populations are still being abused by the pharmaceutical industry and more thought should be given to the notions of volunteers participating in trials and the compensation they receive. In Lebanon, the majority of these difficulties are encountered not only in multicenter international trials but are also seen in the lack of requirements for minimum safety measures and ethical standards when conducting national and regional trials. These insufficiencies raise important questions concerning their real objective.

[Legislative frame and clinical trials in Lebanon]. / Le cadre législatif des essais cliniques au Liban.

UNLABELLED: In Lebanon, as in other developing countries, most of the clinical trials are achieved without considering any rule adopted in the industrialized countries, which causes serious ethical problems. This study aims to review the different Lebanese texts related to clinical trials in order to show the existing legislative frame, and to formulate suggestions that help the legislator defining better this activity. We reviewed and analyzed the Lebanese legislation related to the clinical trials especially the Lebanese law project about "therapeutic trials on human subjects" and conducted semi-directive interviews with actors from the society. RESULTS: We noticed a legislative gap in this domain, highlighting the fragility of the social link in the health domain, and reverberating negatively on the physician/physician, physician/hospital, physician/industrial and industrial/hospital relationships, in addition to many gaps affecting the skills of physicians-investigators. In spite of the promising institutional effort, the national frame of clinical trials does not seem to be sufficient regarding the ignorance of applied legislative texts, the industrial promoter's weight, and the pressures. This is applied to the absence of a powerful national coordinator, the inexistence of a pharmacovigilance system or a skillful authority for the sanitary security of health products, and the confusion in the concepts of medical ethics and deontology. In conclusion were presented for achieving improvements on many levels: an objective criticism of the law project proposed in 2002 followed by a call to review its content and improve it in order to reach an instructive and applicable global legislation ; an action that can be realized only through educating adequately the investigators, and informing the large public in order to guide the governors towards a legislation allowing people in Lebanon to "live well " with complete dignity.