InSilicoUK Pro-Innovation Regulations Network Publishing
Published December 1, 2023 | Version v1
Report Open

Cross-Regulator Workshop: Journeys, experiences and best practices on computer modelled and simulated regulatory evidence— Workshop Report

Creators

  • 1. ROR icon PHG Foundation
  • 2. Clinical Practice Research Datalink
  • 3. Medicines and Healthcare product Regulatory Agency
  • 4. ROR icon University of Manchester

Description

  • Computational modelling and simulation (CM&S) have considerable potential to refine or in some cases replace a significant proportion of late-stage human clinical testing, benefitting patient safety and outcomes, and the economy. However, a key barrier to the adoption and scaling of CM&S methods for life sciences has been identified as uncertainty about regulators' expectations and requirements for CM&S evidence. This workshop sought to discuss those uncertainties across industry, and UK regulatory and certification agencies to see what lessons could be learnt to address remaining ambiguity on its appropriate use for life sciences.
  • There is significant appetite for a consistent effort across UK regulatory agencies to address uncertainties on the use and acceptance of CM&S methods of evidence generation (hereon in 'CM&S methods') across government and regulatory bodies. Cross-Government work is already underway on new approach methodologies (NAMs) which might provide a platform for further coordination. In addition, industry, academia, and wider stakeholders recommended that regulators work towards a high-level consensus statement, signalling their openness towards considering CM&S evidence.
  • A set of general principles for quality model assurance would support good simulation practices and the further adoption of CM&S as an evidence-generation tool. The principles contained in HM Treasury's Aqua book (proportionality, quality assurance, verification and validation, analysis with RIGOUR) provide an excellent starting point and could be tailored to improve their suitability for the regulation of CM&S methods now and in the future while remaining generalisable across sectors.
  • Further engagement with policymakers and the public to understand perceptions of both current (non-simulated) and CM&S methods will assist in identifying optimal language for communicating their risks and benefits, identify sensitivities around their use, and assist in the appropriate development of trusted regulatory approaches.
  • New approach methodologies (NAMs) such as CM&S methods and their capacity to generate further evidence are highly topical given the burgeoning and international interest in AI. The insights from the workshop map out some of the barriers that exist and, in some cases, demonstrate how other industries and sectors have addressed them to help ensure that CM&S methods' potential to support patient outcomes and safety are not missed in the health sector.

Files

Cross_Regulator_Workshop_on_CMS_Report_December_2023_final.pdf

Files (1.1 MB)

Additional details

Dates

Available
2023-12-01