- Research Article
4
- 10.1016/j.therap.2022.11.011
Les essais plateformes
- Dec 05, 2022
- Therapie
- Matthieu Roustit + 18 more +18
Publications from 2021 to 2026
Showing 8 of 8 papers
Les essais plateformes
P67. Comparison of an oral iron supplement with intramuscular iron injection in newborn piglets
Crise sanitaire : quelles opportunités pour la recherche clinique sur le médicament ?
Faire évoluer les pratiques professionnelles d’équipe par la simulation : une étude-pilote en réanimation pédiatrique
Process evaluation of European 'Healthy Stadia' program.
Healthy Stadia (HS) is a European public health pilot-program started in 2007 to support sports stadia in promoting the health of people who work and visit sports stadia, as well as inhabitants of the surrounding communities. The aim of this study is to describe the process evaluation of the program, from its beginning in July 2007 to December 2009, in order to assess the feasibility and sustainability of an HS network across Europe. The program involved nine associate partners involved in the coordination of activities at a local level, in the recruitment of stadia, in the development of specific program tasks and in the dissemination of the program at a national level. The activities of associate partners were evaluated through structured questionnaires administered every 6 months. The questionnaire response rate from associate partners was 77.8% for the first and third evaluations and 88.9% for the second and fourth evaluations. According to the evaluation's results, several good practices such as alcohol prevention policies and those supporting people with disabilities were implemented in stadia over the course of the program. Conversely, practices supporting mental health and green transport were generally not achieved. The implemented activities mainly involved staff and visitors. Lack of human and economic resources, especially toward the end of the program, was considered the principal challenge for program development. In conclusion, the process evaluation presented the feasibility of the HS program and the development of health promoting practices in sport stadia over time.
Read moreCommon definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)
BackgroundThorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states.MethodsIn order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey.ResultsThe ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising.ConclusionThe list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.
Read moreGeologi og grundvand i 3 D - GeoScene3D - nyt værktøj til præsentation
<div>&Aring;rhus Amt har som det f&oslash;rste amt&nbsp;i Danmark valgt at offentligg&oslash;re&nbsp;sine resultater fra den omfattende&nbsp;kortl&aelig;gning af grundvandsressourcerne&nbsp;p&aring; internettet ved hj&aelig;lp af&nbsp;3D-grafik. P&aring; amtets hjemmeside er&nbsp;det muligt at bev&aelig;ge sig rundt b&aring;de&nbsp;over og under jordoverfladen og&nbsp;betragte de geologiske data fra alle&nbsp;vinkler &ndash; n&aelig;rmest som i et computerspil.</div>
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