Policy brief: Accelerating the uptake of in silico trials in healthcare

A policy brief is a concise document that articulates information and analysis, offering evidence-based recommendations to address a specific (policy) issue. Typically (but not solely) targeted at policymakers, it aims to succinctly convey the key aspects of a problem, present viable solutions, and provide a rationale for the proposed course of action. The document is characterised by brevity, clarity, and objectivity, serving as a tool to inform decision-makers about the complexities of a given (policy) challenge and to guide them in making informed choices. The information incorporated in this document stems from a range of stakeholder engagement activities conducted as part of the In Silico World’s “Communication, Dissemination and Stakeholder Engagement” activities, including a desk review, a Delphi survey, a clinical survey, three geographically spread focus groups, a final Responsible Research and Innovation workshop, and several consensus processes run on various topics through the In Silico World Community of Practice, an online forum that sees the participation of over 700 experts from academia, industry, governmental agencies, healthcare providers, etc. The valuable insights acquired through this extensive engagement with diverse stakeholders have elucidated the crucial actions required to reduce the barriers hindering the advancement and uptake of in silico trial technologies. These findings align seamlessly with the overarching objective of the In Silico World project. The policy brief outlines the essential engagement strategies for each stakeholder group. It starts with the context of the letter, providing background information on the topic of in silico trials, its stakeholders (academia, industry, healthcare providers, regulators, HTA and payers, policymakers, patients and public) and their public values, as obtained from a Delphi survey. Next, the challenges are listed as they have been identified at the project onset and through stakeholder engagement activities such as surveys and focus groups. This is followed by a discussion of the co-creation of governance solutions. In the context of this policy brief, governance refers to the structured framework through which research and innovation are managed and coordinated. Possible governance mechanisms entail regulations, principles, standards, securitisation efforts, codes of conduct, impact assessments, or value statements. Based on this information, general action points and policy recommendations are formulated, followed by specific action points for each stakeholder category independently. The key messages of this policy brief are as follows. - Promote in silico medicine through science communication and outreach activities with a wide range of stakeholders. - Educate and train all stakeholders, with a focus on clinicians, engineers, and the public. - Recognise and involve patient expertise. - Address malicious uses and ethical responsibilities, acknowledge limitations of the technologies, and detail context-of-use for building trust by creating ethical manifestos or codes of conduct. - Foster interdisciplinary collaboration with diverse stakeholders to ensure the development is in line with the expectations, needs and values of all stakeholders while ensuring inclusion of underrepresented populations. Integrate social sciences and humanities (SSH) for a comprehensive understanding of ethical, legal, and social concerns. - Promote the transitional adoption of VV-40 in Europe as well as the development of an EU-harmonized standard. - Foster collaborations with regulators and policymakers. Develop a specific set of recommendations to lower regulatory barriers.