This document discusses improving the use of academic data in regulatory assessments by addressing issues related to how the data is generated, documented, retrieved, and evaluated. It proposes developing guidance to help researchers better design and report studies to facilitate regulatory uptake. It also suggests creating a search guide to help assessors find, access, and evaluate academic data from scientific sources by building on existing tools and repositories. This would help implement the requirement to consider all available information in assessments.

1. Antonio Franco
OECD webinar 16-03-22
Building trust in the scientific evidence bae supporting chemical risk assessment nd the role fo the AOP framework
Building trust through improved
tools and practice in the life cycle
of mechanistic data

2. • published in scientific literature
• not carried out specifically to inform regulatory assessments
• often using non-standard (non-guideline) experimental (animal and non-animal) or computational
methods, without necessarily complying with any recognised quality system
• from traditional (apical) to mechanistic data
Use of academic data in regulatory assessments
Information
requirements
• …
• …
• Academic
data
Assessments
• …
• …
• Academic
data
Decisions

3. EU policy evaluation
EU policy fitness checks1 identified issues related to the way academic data is used in regulatory
assessments:
1. The need to improve performing and reporting applied in peer-reviewed studies to meet
regulatory requirements
2. The need to improve implementation of the regulatory requirement to consider all available
information when carrying out assessments
1 COM(2019)264 EUR-Lex - 52019DC0264 - EN - EUR-Lex (europa.eu)
SWD (2019) 199 EUR-Lex - 52019SC0199 - EN - EUR-Lex (europa.eu)

4. The life cycle of academic data
•Registrants
•EU agencies and scientific
committees
•Member States authorities
•Registrants
•EU agencies
•Member States authorities
•Researchers
•Editors
•Publishers
•Reviewers
•Repositories managers
•Funders
•Researchers
Data
Generation
Documenting
and reporting
Retrieving
Evaluation and
use for hazard
and risk
assessments

5. Examples from REACH
Analysis of provenance of key studies in REACH restrictions*
• Non-standard studies comprise the majority of key studies in
REACH restrictions.
• About 30 % of data relevant for the restrictions were not
included in REACH registration dossiers The majority of them
(14/16) were non-standard studies.
* Borchert, Beronius, Ågerstrand. 2022. Non-standard studies play and important role in the
restriction of hazardous substances under REACH regulation (provisional results, manuscript
under review)
3) Restriction
1) Registration
• Information requirements
• Evidence supporting read-across in
adaptation to standard information
requirements (e.g. QSARs, in vivo, in vitro,
toxicokinetic, omics)
2) Assessment of regulatory needs
• Streamlined workflow for substance groups
(e.g. ED screening using ToxCast/EDSP
data)
41%
1%
39%
19%
58%

6. Mapping of existing resources
(OECD)
Available resources (standards/tools/guidance) Production Documentation Accessibility Use
Improving performing and
reporting
Improving implementation of
requirements to consider all
available information
OECD Adverse Outcome Pathway framework and knowledge base (AOP-KB)
OECD Guidance Document on Good In Vitro Method Practices (GIVIMP)
OECD Integrated approaches for testing and assessment (IATA) to ensure
relevance and added value of new data/methods in regulatory assessments
OECD guidance document on Characterisation, validation and reporting of
Physiologically Based Kinetic (PBK) models for regulatory purposes
OECD guidance document on the validation of QSAR models for regulatory
purposes
OECD harmonised templates (e.g. OHTs 41-86, OHT 201)
OECD Guidance Document for describing non guideline in vitro test methods
and associated templates to implement the guidance
OECD Reporting framework for transcriptomics and metabolomics in
regulatory toxicology
New scientific-user-friendly version of IUCLID incorporating OHT201/ EASIS

7. EU Open Science resources incl. Open Research Europe (ORE)
Directive 2010/63 related guidance and e-learning resources
Endocrine Active Substances Information System (EASIS)
Information Platform for Chemical Monitoring (IPCHEM)
ChemAgora portal for searching online chemical data repositories
ECHA guidance on information requirements and CSA - Evaluation of
available information R4
SCCS Notes of Guidance (2021)
EFSA guidance on the selection and reporting of peer reviewed studies on
pesticide active substances
EFSA guidance on systematic review methodology to food and feed safety
assessments
Artificial intelligence tools for systematic reviews (EFSA project)
Available resources (standards/tools/guidance) Production Documentation Accessibility Use
Improving performing and
reporting
Improving implementation of
requirements to consider all
available information
Mapping of existing resources
(EU institutions and agencies)

8. Assay Guidance Manual (NIH)
Equator network reporting guidelines – Enhancing the quality and
transparency of health research (STROBE, CONSORT)
Planning Research and Experimental Procedures on Animals:
Recommendations for Excellence (PREPARE) guidelines (Norcopa)
Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines
(N3CRs)
Methods and protocols repositories (e.g. Protocols.io, Protocols Exchange)
Public/commercial search engines such as Web of Science, PubChem,
Toxnet, SciFinder, Google, etc.
WikiPharma database of ecotoxicological data of pharmaceuticals and
WikiREACH concept
SciRAP (Science in Risk Assessment and Policy) tool
CompTox Chemicals
EPA Tools for systematic evidence gathering and review (e.g. HAWC,
SWIFT, HERO, IRIS)
WHO framework for the use of systematic review in chemical risk
assessment
Available resources (standards/tools/guidance) Production Documentation Accessibility Use
Improving performing and
reporting
Improving implementation of
requirements to consider all
available information
Mapping of existing resources
(International organisations)

9. • helps researchers to design, perform and report studies,
facilitating regulatory uptake
• broad scope (e.g. in vivo, in vitro, computational
modelling, omics etc.)
• builds on existing resources
• entry point for academics to identify requirements
• provides pointers to specific quality documents
• highlights the benefits for the data generators to
implement the guidance (developing editorial/funders
policy)
Guidance setting minimum quality and reporting
requirements

10. Search guide for finding and retrieving academic
data
• Implementing the requirements to consider “all available
information” in regulatory assessments
• helps assessors to find, access and evaluate academic
data from scientific sources
• builds on established tools and practice
• solutions may include:
• pre-defined search and screening criteria
• automated solutions, including study repositories and alerts
• open access platforms, databases in harmonised format
• regulatory mechanism to apply the search guide/strategy

11. 11
Search guide – options (I)
• Guidance / search guide
• A guidance to screen for academic data (building
on search and retrieve steps of EFSA guidance
systematic review)
• A search tool listing to existing repositories of
studies, structured data and knowledge

12. • Guidance / search guide
• Repository of academic studies
• Based on pre-defined relevance and quality
criteria
• Based on outcome of systematic reviews
performed by assessors
• Proposed by reviews performed by scientists
12
Search guide – options (II)

13. • Guidance / search guide
• Repository of academic studies
• Structured data and knowledge
management tools
• Substance DBs (e.g. Endocrine Active
Substances Information System, EASIS)
• Test methods DBs (e.g. TSAR)
• AOP-Wiki
• …
13
Search guide – options (III)
Substance
data
AOP
knowledge
Test method
information
Test methods DBs
…
…
Substance DBs
…
…
EASIS 2.0

14. 14
Thanks for your attention