The Safety Methodology Implementation Group was established within the EFSPI/PSI Benefit–Risk Special Interest Group to address a persistent challenge in drug development:

• translating advances in quantitative safety science into methods that are
  routinely and effectively used in practice.

The group brings together statisticians and safety experts from industry and partner organisations to

• focus on practical implementation, rather than methodological invention alone.

Its remit spans the full pharmaceutical development lifecycle, with an emphasis on improving regulatory compliance, scientific rigor, and the real-world‑ impact of safety analyses.

Purpose and Remit

The overall purpose of the group is to accelerate the adoption of innovative safety methodologies into routine use, by identifying barriers to implementation and developing practical, actionable solutions.

Key aspects of the remit include:

• Understanding regulatory, organisational, and technical challenges that limit uptake of advanced safety methods
• Developing pragmatic approaches that can be implemented within current regulatory frameworks
• Supporting statisticians and safety scientists with guidance, examples, and (where appropriate) reusable analytical tools
• Encouraging collaboration and alignment across companies to reduce variability in safety practice

The group’s work is organised into complementary workstreams, each addressing a critical aspect of safety methodology implementation.

1. From Quantitative Invention to Safety Innovation

This workstream (led by Dooti Roy) focuses on why promising quantitative safety methods often take years to move from development into routine use, despite clear scientific value. The group examines:

• Limitations of traditional safety analyses, such as reliance on simple incidence rates and aggregate summaries
• The role of regulatory expectations (including FDA and EMA perspectives) in shaping adoption
• Organisational enablers such as infrastructure, training, and stakeholder engagement

Through real-world‑ case studies—including Bayesian methods, systematic safety surveillance, and interactive safety visualisations—the workstream highlights both opportunities and practical barriers to implementation, with the aim of identifying strategies that help innovations achieve real impact.

2. Aggregate Safety Reporting Beyond SUSARs

A second workstream (led by Matthias Trampisch) addresses the statistical and operational challenges of aggregate safety reporting, particularly for anticipated serious adverse events (SAEs) in investigational trials.

Key topics include:

• Practical implementation of FDA IND safety reporting requirements for anticipated SAEs
• Clarification on Safety Assessment Entity and unblinded analyses to identify clinically meaningful imbalances while maintaining trial integrity
• Comparison of Statistical Analysis Data Centre (SDAC) operational models, including external CROs and internal independent Statistical Analysis Teams (iSATs)

The group explores governance models, data handling, and documentation practices, including the role of Safety Surveillance Plans, trigger based‑ versus periodic unblinding strategies, and mitigation of common operational challenges such as data transfers and independence within sponsor organisations.

The aim is to translate regulatory guidance into clear, actionable steps that can be applied consistently across trials.

3. Operationalising Integrated Summary of Safety (ISS) Development

The third workstream (led by Florence Le Maulf) is focused on supporting statisticians and clinicians working on Integrated Summaries of Safety (ISS), where approaches to safety data analysis and presentation can vary widely between organisations.

The group is developing a practical ISS Toolkit, covering key methodological topics such as:

• Pooling strategies across studies
• Grouping of adverse event terms
• Exposure and study size‑ adjustment
• Data presentation and standardisation

For each topic, the toolkit aims to provide:

• A synthesis of existing guidance and published literature
• Clear best practice‑ recommendations
• Example SAP text and table/figure shells
• Potential analytical code to support implementation

This workstream seeks to reduce variability in ISS approaches and provide a cohesive, accessible resource for safety teams.

2026 Objectives

• Produce meaningful content (e.g. papers, guidance, toolkit) for each of the workstreams.
• Share outcomes with the global pharmaceutical statistical community via conference sessions, webinars and partnering with other organisations such as ASA Biopharma Safety WG and PHUSE Safety Analytics WG.

How to get in touch

The working group co-leads are Naomi Givens and Dooti Roy. If you are interested in hearing more or getting involved, please contact Naomi Givens, Dooti Roy or workstream leads Matthias Trampisch and Florence Le Maulf.