Implementation of PROMETHEUS 4-step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions

Aiassa, Elisa and Martino, Laura and Barizzone, Fulvio and Ciccolallo, Laura and Garcia, Ana and Georgiadis, Marios and Guajardo, Irene Muñoz and Tomcikova, Daniela and Alexander, Jan and Calistri, Paolo and Gundert-Remy, Ursula and Hart, Andrew David and Hoogenboom, Ron Laurentius and Messean, Antoine and Naska, Androniki and Navarro, Maria Navajas and Noerrung, Birgit and Ockleford, Colin and Wallace, Robert John and Younes, Maged and Abuntori, Blaize and Alvarez, Fernando and Aryeetey, Monica and Baldinelli, Francesca and Barrucci, Federica and Bau, Andrea and Binaglia, Marco and Broglia, Alessandro and Castoldi, Anna Federica and Christoph, Eugen and Sesmaisons-Lecarré, Agnes De and Georgiadis, Nikolaos and Gervelmeyer, Andrea and Istace, Frederique and López-Gálvez, Gloria and Manini, Paola and Maurici, Daniela and Merten, Caroline and Messens, Winy and [Unknown], Olaf Mosbach-Schulz and Putzu, Claudio and Bordajandi, Luisa Ramos and Smeraldi, Camilla and [Unknown], Manuela Tiramani and Martínez, Silvia Valtueña and Sybren, Vos and Hardy, Anthony Richard and [Unknown], Marta Hugas and Kleiner, Juliane and Seze, Guilhem De (2018) Implementation of PROMETHEUS 4-step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions. EFSA Supporting Publications, 15 (4). ISSN 2397-8325

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In 2014, the European Food Safety Authority (EFSA) started the PROMETHEUS (PROmoting METHods for Evidence Use in Scientific assessments) project to improve further and increase the consistency of the methods it uses in its scientific assessments. The project defined a set of principles for the scientific assessment process and a 4-step approach (plan/carry out/verify/report) for their fulfilment, which was tested in ten case studies, one from each EFSA panel. The present report describes the benefits, issues, needs and solutions related to the implementation of the 4-step approach in EFSA, identified in a dedicated workshop in October 2017. The key benefits of the approach, which was deemed applicable to all types of EFSA scientific assessment including assessments of regulated products, are: 1) increased ?scientific value? of EFSA outputs, i.e. the extent of impartiality, methodological rigour, transparency and engagement; 2) guarantee of fitness-for-purpose, as it implies tailoring the methods to the specificities of each assessment; 3) efficiency gain, since preparing a protocol for the assessment upfront helps more streamlined processes throughout the implementation phase; 4) innovation, as the approach promotes the pioneering practice of ?planning before doing? (well established in primary research) for broad scientific assessments in regulatory science; and 5) increased harmonisation and consistency of EFSA assessments. The 4-step approach was also considered an effective system for detecting additional methodological and/or expertise needs and a useful basis for further defining a quality management system for EFSA's scientific processes. The identified issues and solutions related to the implementation of the approach are: a) lack of engagement and need for effective communication on benefits and added value; b) need for further advances especially in the field of problem formulation/protocol development, evidence appraisal and evidence integration; c) need for specialised expertise in the previous aspects; and specific needs for d) assessments of regulated products and e) outsourced projects.

Item Type:
Journal Article
Journal or Publication Title:
EFSA Supporting Publications
Additional Information:
doi: 10.2903/sp.efsa.2018.EN-1395
ID Code:
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Deposited On:
29 Jan 2019 14:30
Last Modified:
12 Sep 2020 07:25