Get ready for an exciting leap forward in UK healthcare innovation! We're bringing together a dynamic, pro-innovation community focused on shaping a national strategy that's all about fast-tracking the adoption of in silico trials. This cutting-edge approach isn't just a tech marvel; it's a game-changer for the UK’s LifeSciences sector.
We're not starting from scratch – our strategy takes the best of previous government policies and turbocharges them to meet today's unique challenges and opportunities. Think of it as a launchpad for medical innovations that are not only faster and safer but also more cost-effective.
And here's the best part: We're aligning our efforts with a growing body of national and international evidence and initiatives.
Our goal? To deliver medical breakthroughs that benefit patients, spur economic growth, and place the UK at the forefront of healthcare innovation. Get ready for a healthier, brighter future!
Complementary sources of scientific evidence and drive confidence in patient benefit, safety, and effectiveness
Transforming the UK into the premier hub for pioneering medical innovations, where in silico evidence and cutting-edge regulatory science converge to create a thriving environment for healthcare breakthroughs!
Where in silico evidence and cutting-edge regulatory science converge to create a thriving environment for healthcare breakthroughs!
To widely adopt in silico evidence in regulatory practice, our community is tackling the following challenges
Validation and Verification: Ensuring the accuracy and reliability of in silico models is crucial. Regulators need robust methods to verify and validate these models to ensure they accurately predict clinical outcomes. This involves establishing the credibility of the model for the intended context of use.
Standardisation: There is a need for standardised methodologies in the development and use of in silico models. This includes standardising how data is collected, analyzed, and reported. Without standardisation, it can be challenging to compare and assess the results of different in silico trials.
Data Quality and Availability: High-quality data is essential for building and validating in silico models. There are challenges in accessing sufficient, high-quality clinical data due to privacy concerns, data sharing restrictions, and variability in data collection methods.
Regulatory Framework: Existing regulatory frameworks were primarily designed for traditional clinical trials. Adapting these frameworks to accommodate in silico trials, including new types of evidence and methodologies, poses a significant challenge.
Interdisciplinary Expertise: In silico trials require expertise in computational modeling, clinical science, and regulatory affairs. There is a need for professionals who can understand and bridge these disciplines to effectively develop and evaluate in silico models.
Ethical and Legal Considerations: The use of patient data in developing and validating in silico models raises ethical and legal questions. Issues around consent, data privacy, and the potential biases in model development need to be addressed.
Transparency and Public Trust: Ensuring transparency in how in silico models are developed and used is vital for building public trust. Regulators must ensure that these models are not "black boxes" and that their decision-making processes are explainable and understandable.
Global Harmonisation: Different countries may have varying standards and regulations regarding in silico trials. Harmonizing these regulations internationally can be challenging but is important for the global development and approval of medical products.
Addressing these challenges requires collaborative efforts among regulatory agencies, industry, academia, and other stakeholders. Ongoing dialogue and the development of guidelines and best practices are essential for the successful integration of in silico trials into the regulatory landscape.
A community driving innovation and growth for patient safety and benefit using in silico evidence and regulatory science
Rt Hon Sir Iain Duncan Smith MP, the Rt Hon Theresa Villiers MP, and George Freeman MP, The Taskforce on Innovation, Growth and Regulatory Reform
Lord Frost statement to the House of Lords on Brexit opportunities, Sep 16th 2021.
Coordinated by InnovateUK KTN and the Royal Academy of Engineering, in collaboration with Avicenna Alliance and the Virtual Human Physiological Institute, we work with trade organisations, regulators, standardisation bodies and UK government.