Guidance on protocol development for EFSA generic scientific assessments

EFSA Scientific Committee, Simon More, Vasileios Bampidis, Diane Benford, Claude Bragard, Antonio Hernández-Jerez, Susanne Hougaard Bennekou, Konstantinos Panagiotis Koutsoumanis, Claude Lambré, Kyriaki Machera, Ewen Mullins, Søren Saxmose Nielsen, Josef Schlatter, Dieter Schrenk, Dominique Turck, Maged Younes, Andrew Kraft, Hanspeter Naegeli, Katya Tsaioun, Elisa AiassaDavide Arcella, Fulvio Barizzone, Maeve Cushen, Marios Georgiadis, Andrea Gervelmeyer, Anna Lanzoni, Paolo Lenzi, Federica Lodi, Laura Martino, Winy Messens, Luisa Ramos Bordajandi, Valentina Rizzi, Giuseppe Stancanelli, Špela Supej, Thorhallur Ingi Halldorsson

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Abstract

EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ?Draft framework for protocol development for EFSA's scientific assessments? published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the ?APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and ? not covered in this guidance ? generating empirical evidence ex novo. The guidance is complemented by a standalone ?template? for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.
Original languageEnglish
Article numbere08312
JournalEFSA Journal
Volume21
Issue number10
Pages (from-to)1-68
Number of pages68
ISSN1831-4732
DOIs
Publication statusPublished - 2023

Bibliographical note

Publisher Copyright:
© 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

Keywords

  • APRIO
  • generic scientific assessments
  • guidance
  • methods
  • PECO
  • PICO
  • planning
  • problem formulation
  • protocol development

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