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• W178587803 abstract "A study was conducted to examine whether the decision to interrupt a protocol, deeply dependent on the benefice/risk ratio, especially in the gene therapy field of research where biologists and physicians, were directly related. This study helped to identify various criteria pointed out by the researchers. So, when an unexpected and serious event happened, about two-thirds of the population declared being in favor of the interruption of the protocol. A serious and expected event is defined by the death of a patient or a highly allergic reaction. When multiple, less serious events occur, about 53% of the population is also in favor of an interruption of a protocol, but the correlation between these incidents and the protocol has to be clearly demonstrated. The benefice/risk ratio has to be evaluated before each decision. A codification of the criteria, helping in the evaluation of the benefice/risk ratio could be developed in the future in gene therapy, whose goal is the long-term modification of a gene correcting a nonfunctional molecule. So, when a physician decides to include a person to a protocol or to interrupt a protocol, he needs to keep in mind the possible benefit that other patient could have if the protocol continues. About 90% of the population is in favor of the creation of a multidisciplinary independent European and transnational committee involved and specialized in the regulation of gene therapy. The decision to interrupt a protocol is deeply dependent on the benefice/risk ratio, especially in the gene therapy field of research where biologists and physicians are directly related. Through the 350 gene therapy researchers selected, because they have presented a research poster during the XIth annual congress of the European Society of Gene Therapy in Edinburgh (November 2003), 62 answered our online anonymous questionnaire. Some important possible axis of regulation criteria and processes were underlined. The online version of this questionnaire is still available on our website: http://sergent.jacques.free.fr. Questioned about three main research axis (criteria suggested, legitimate and proper process to regulate research and the necessity of a moratorium on somatic gene therapy), the gene therapy community has demonstrated the importance of a proper regulation. Suggesting the Jesse Gelsinger case (1999) and the Bubble kids of Necker (2002), they have also demonstrated their wish to see a regulation process involving a committee, particularly because of their transnational and multidisciplinarity qualities. The possible interactions with not only the patients but also the associations of patients were also pointed out. A regulation mediated by the national ministries was the unique process that encountered more than 50% of approval. The necessity to have a European regulation through a committee has been demonstrated. In fact, about 75% of the researchers encourage a European regulation and approve the extension of a decision taken in one European country to the European community, if this decision is scientifically demonstrated for a multi-country shared protocol. Nevertheless, only 50% of the population approve the creation of a European law, which cannot be adapted to each individual decision. The inter-activity, which exists in a committee, is the characteristic mentioned by the population, determinant in a possible European regulation. The unawareness of the actual charters and declarations with interest in gene therapy has also been shown by this study, especially by the directors of laboratories or studies." @default.
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• W178587803 date "2006-01-01" @default.
• W178587803 modified "2023-10-15" @default.
• W178587803 title "European Analysis of the Various Procedures Existing to Interrupt a Clinical Research Protocol Thanks to a French Example of Gene Therapy" @default.
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• W178587803 doi "https://doi.org/10.1016/b978-044452806-3/50017-2" @default.
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