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

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

In: EFSA Supporting Publications, Vol. 15, No. 4, 1395E, 04.2018.

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@article{e6591246722a4714851917c0c0e88ed7,
title = "Implementation of PROMETHEUS 4-step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions",
abstract = "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.",
author = "{EFSA Scientific Committee} and Elisa Aiassa and Laura Martino and Fulvio Barizzone and Laura Ciccolallo and Ana Garcia and Marios Georgiadis and Guajardo, {Irene Mu{\~n}oz} and Daniela Tomcikova and Jan Alexander and Paolo Calistri and Ursula Gundert-Remy and Hart, {Andrew David} and Hoogenboom, {Ron Laurentius} and Antoine Messean and Androniki Naska and Navarro, {Maria Navajas} and Birgit Noerrung and Colin Ockleford and Wallace, {Robert John} and Maged Younes and Blaize Abuntori and Fernando Alvarez and Monica Aryeetey and Francesca Baldinelli and Federica Barrucci and Andrea Bau and Marco Binaglia and Alessandro Broglia and Castoldi, {Anna Federica} and Eugen Christoph and Sesmaisons-Lecarr{\'e}, {Agnes De} and Nikolaos Georgiadis and Andrea Gervelmeyer and Frederique Istace and Gloria L{\'o}pez-G{\'a}lvez and Paola Manini and Daniela Maurici and Caroline Merten and Winy Messens and Olaf Mosbach-Schulz [Unknown] and Claudio Putzu and Bordajandi, {Luisa Ramos} and Camilla Smeraldi and Manuela Tiramani [Unknown] and Mart{\'i}nez, {Silvia Valtue{\~n}a} and Vos Sybren and Hardy, {Anthony Richard} and Marta Hugas [Unknown] and Juliane Kleiner and Seze, {Guilhem De}",
note = "doi: 10.2903/sp.efsa.2018.EN-1395",
year = "2018",
month = apr,
doi = "10.2903/sp.efsa.2018.EN-1395",
language = "English",
volume = "15",
journal = "EFSA Supporting Publications",
issn = "2397-8325",
publisher = "John Wiley & Sons, Ltd",
number = "4",

}

RIS

TY - JOUR

T1 - Implementation of PROMETHEUS 4-step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions

AU - EFSA Scientific Committee

AU - Aiassa, Elisa

AU - Martino, Laura

AU - Barizzone, Fulvio

AU - Ciccolallo, Laura

AU - Garcia, Ana

AU - Georgiadis, Marios

AU - Guajardo, Irene Muñoz

AU - Tomcikova, Daniela

AU - Alexander, Jan

AU - Calistri, Paolo

AU - Gundert-Remy, Ursula

AU - Hart, Andrew David

AU - Hoogenboom, Ron Laurentius

AU - Messean, Antoine

AU - Naska, Androniki

AU - Navarro, Maria Navajas

AU - Noerrung, Birgit

AU - Ockleford, Colin

AU - Wallace, Robert John

AU - Younes, Maged

AU - Abuntori, Blaize

AU - Alvarez, Fernando

AU - Aryeetey, Monica

AU - Baldinelli, Francesca

AU - Barrucci, Federica

AU - Bau, Andrea

AU - Binaglia, Marco

AU - Broglia, Alessandro

AU - Castoldi, Anna Federica

AU - Christoph, Eugen

AU - Sesmaisons-Lecarré, Agnes De

AU - Georgiadis, Nikolaos

AU - Gervelmeyer, Andrea

AU - Istace, Frederique

AU - López-Gálvez, Gloria

AU - Manini, Paola

AU - Maurici, Daniela

AU - Merten, Caroline

AU - Messens, Winy

AU - [Unknown], Olaf Mosbach-Schulz

AU - Putzu, Claudio

AU - Bordajandi, Luisa Ramos

AU - Smeraldi, Camilla

AU - [Unknown], Manuela Tiramani

AU - Martínez, Silvia Valtueña

AU - Sybren, Vos

AU - Hardy, Anthony Richard

AU - [Unknown], Marta Hugas

AU - Kleiner, Juliane

AU - Seze, Guilhem De

N1 - doi: 10.2903/sp.efsa.2018.EN-1395

PY - 2018/4

Y1 - 2018/4

N2 - 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.

AB - 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.

U2 - 10.2903/sp.efsa.2018.EN-1395

DO - 10.2903/sp.efsa.2018.EN-1395

M3 - Journal article

VL - 15

JO - EFSA Supporting Publications

JF - EFSA Supporting Publications

SN - 2397-8325

IS - 4

M1 - 1395E

ER -