Grégoire Moutel

Information and decision‐making process for selective termination of dichorionic pregnancies: some French obstetricians' points of view

In France, neither Bioethics Law nor law related to abortion make reference to selective terminations (ST). Because they apply in the context of multiple pregnancies, ST raises problems which differ from those we usually see in prenatal medicine.

Reporting of ethical requirements in phase III surgical trials

Background Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research. Objective Our aim was to assess whether REC approval and ICP were documented in surgical trials. Study design Overall, 657 randomised trials, published between 2005 and 2010 in 10 international journals, were included. We collected the report rate of REC approval and ICP and contacted the corresponding author when ethical information was lacking. Results Among the 657 randomised controlled trials (RCT), 576 (87.7%) stated that an REC had approved the research, and 606 (92.2%) stated that ICP had been requested. Furthermore, 28 RCTs (4.3%) reported neither REC nor ICP. Conclusions The phase III randomised surgical trials that were analysed were shown to have respected fundamental ethical principles in approximately 90% of the cases examines.

Reporting on Quality of Life in Randomised Controlled Trials in Gastrointestinal Surgery

BackgroundAlthough health-related quality of life (HRQOL) has become an important outcome measure in surgical trials, questions still remain about the quality of its reporting. The aim of this study was to evaluate HRQOL assessment methodology of randomised clinical trials concerning gastrointestinal surgery.MethodsAll articles published in the calendar years 2006 and 2007 that purported to assess quality of life as end points or make some conclusion about quality of life were chosen for review from eight general surgical journals and four medical journals. Identified eligible studies were selected and then evaluated on a broad set of predetermined criteria.ResultsTwenty-four published randomised controlled clinical trials (RCTs)s with an HRQOL component were identified. Although most trials exhibited good-quality research, some methodological limitations were identified: Only 21% of the studies gave a rationale for selecting a specific HRQOL measure, 46% of the studies failed to report information about the administration of the HRQOL measure, and 37% did not give details on missing data.ConclusionsAlthough it is clear that HRQOL is an important end point in surgical RCTs because the information helps to influence treatment recommendations, a number of methodological shortcomings have to be further addressed in future studies.

European Analysis of the Various Procedures Existing to Interrupt a Clinical Research Protocol Thanks to a French Example of Gene Therapy

Publisher Summary 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. Abstract 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.