The overall objective of project OC/EFSA/AMU/2018/01 was to support EFSA to develop in-house capacity to collect, appraise and synthesize evidence coming from literature sources in the context of food and feed scientific assessment. This objective had to be reached by offering 3 different types of training courses to EFSA staff (including Trainees) and Experts (of Panels, Working Groups and Member States). This report summarizes these trainings and their evaluation. Between 15 October 2018 and 24 November 2020, 9 trainings were delivered by a team of trainers from SYRCLE (SYstematic Review Centre for Laboratory animal Experimentation, www.syrcle.nl) and partners. A total number of 160 people participated in these trainings (an average of 18 per training), some of whom participated in more than one training (day). The individual trainings were evaluated using an online evaluation form, which consisted of general questions (e.g. about the training room or course material) and specific questions about the various parts of the training courses. The participants had the option of adding qualitative comments. Moreover, a so-called second level evaluation was used to assess the extent to which the trainings improved the capacity of participants to use the techniques explained in the courses in the context of EFSA assessments. With an average score of 8.23 (out of 10), the trainings were evaluated very positively. Major revisions of the content were only necessary for two of the courses and only after the first editions. Overall, the participants assessed their knowledge and practical skills to be higher after the training compared to before. Moreover, two of the online editions of the courses received an EFSA Golden Globe for the most successful EFSA scientific courses delivered in 2020. Based on the experiences with this series of trainings, recommendations are made for future EFSA trainings in evidence synthesis.
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From the article: Abstract Sub-chronic toxicity studies of 163 non-genotoxic chemicals were evaluated in order to predict the tumour outcome of 24-month rat carcinogenicity studies obtained from the EFSA and ToxRef databases. Hundred eleven of the 148 chemicals that did not induce putative preneoplastic lesions in the sub-chronic study also did not induce tumours in the carcinogenicity study (True Negatives). Cellular hypertrophy appeared to be an unreliable predictor of carcinogenicity. The negative predictivity, the measure of the compounds evaluated that did not show any putative preneoplastic lesion in de sub-chronic studies and were negative in the carcinogenicity studies, was 75%, whereas the sensitivity, a measure of the sub-chronic study to predict a positive carcinogenicity outcome was only 5%. The specificity, the accuracy of the sub-chronic study to correctly identify non-carcinogens was 90%. When the chemicals which induced tumours generally considered not relevant for humans (33 out of 37 False Negatives) are classified as True Negatives, the negative predictivity amounts to 97%. Overall, the results of this retrospective study support the concept that chemicals showing no histopathological risk factors for neoplasia in a sub-chronic study in rats may be considered non-carcinogenic and do not require further testing in a carcinogenicity study.
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