Fiona Maini, senior director global compliance and strategy at Medidata, a Dassault Systèmes company, outlines the challenges that regulation has with keeping up with technology in 2024.
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Keeping pace concept
Over the past decades, we have seen science and technology progress at a phenomenal rate which is a trend that continued throughout last year. Whilst these progressions are pushing innovation there is often a gap between innovation and regulatory frameworks which is often called the pacing problem. Regulators are on a constant learning curve with new innovations; and keeping up more than ever. The innovation offices now established at the regulatory authorities have created a win-win scenario. Here clinical stakeholders can discuss and work with the regulators, helping them to understand the innovations which will become a new normal for clinical research, while retaining their pragmatic and proportional-risk approach to approvals.
Medidata
Fiona Maini
In this industry, success is often measured in regulatory approvals – so, what is being done to address this delay in approvals, and what progress can we expect in 2024?
It's about AI advancing into broader clinical areas
Artificial Intelligence was one of the hot topics for the industry in 2023 with the potential benefits of the technology becoming increasingly apparent across the sector, and we are already seeing the impact of AI in drug development, medical imaging, diagnostics and, more generally, across clinical research. At the heart of clinical trials is the collection, synthesis, and analysis of large volumes of complex data, and AI offers new solutions in the management of this data, creating new efficiencies and accelerating the trial process. AI can improve trial design by aiding the selection of trial sites and it can give investigators and clinical staff the tools to support better patient care therefore improving the patient experience.
Regulatory frameworks allow the incorporation of these high-tech solutions into trial design (and the healthcare sector more widely) in a responsible manner, ensuring the prioritisation of ethical principles at every step of the journey. Potential barriers to the adoption of new technology, such as the right to data privacy, must be rigorously evaluated to protect patients and maintain good healthcare outcomes. The associated challenge is the upskilling required to bring regulators and other stakeholders up to speed with the latest developments in as close to real time as possible, all whilst ensuring they have a comprehensive understanding of the processes involved. Regulators need a good grounding in the latest technological advances to understand both the benefits and risks, and therefore produce informed, timely guidance to provide clarity for the industry and ensure patient safety.
This is no easy task, but the modernisation of regulatory frameworks to capture these innovations has been progressing at an impressive rate. For example, the EU AI Act, initially proposed in 2021 and updated in 2023, lays out the foundations for the use of ethical and trustworthy AI, and for validating and controlling algorithms via a risk-based approach. As with any new regulation, there are always challenges to overcome and understanding the impact of any new rules regarding, for example, the current EU MDR will be vital for the successful implementation of new technologies. Ensuring that regulations are clear, and that there are enough notified bodies to certify new technology and devices and effectively support the industry, is instrumental for the timely approval of novel scientific and technological advancements.
Keeping pace – what’s next?
Over the past few years, there has been a significant increase in the number of innovation offices at regulatory authorities, allowing developers to present technology at an earlier stage. This helps to minimise the lag time before regulatory guidance can be developed. This open-door policy demonstrates an ongoing commitment from regulators to embrace scientific and technological change more than ever before.
However, keeping up with major breakthroughs in the industry requires forward planning. That’s why a working group at the European CRO Federation (EUCROF) is looking at the future of clinical trials and new technologies that may impact clinical research as well as the role of regulation within this. EUCROF regularly engages with a range of stakeholder groups across the clinical research space to build a well-rounded picture of the direction of travel. This type of work is vital to ensure that we have the right resources and people in place to accelerate approvals and promote the prompt implementation of these scientific and technological innovations, ultimately for the benefit of patients.
Another development on the horizon is the finalisation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) third revision of their Good Clinical Practice guidelines, which is expected soon. This framework will address key concerns regarding data governance, which is an important aspect for patient care within the wider use of data and AI in healthcare. The European Medicines Agency (EMA) has also published a draft reflection paper on AI across a medicine’s lifecycle. These developments in the regulatory space represent a drive to champion advancements in the industry, accelerating the speed at which these innovations can reach patients and healthcare professionals for the benefit of the sector more widely.
But how?
Barriers to achieving and, crucially, maintaining this pace remain centred around resourcing and budgeting. As the science and technology continues to develop, new training schemes are required to ensure an understanding of the advancements, which places a significant burden on regulatory authorities in terms of the time and cost required. Using forward looking plans to ensure appropriate time and resource allocation in anticipation of major industry innovations will be beneficial in reducing any delay in regulatory approvals.
Leveraging regulation for industry growth
When new guidelines are released, there tends to be an increased confidence from industry to work in these areas; conservatism stems from not wanting to invest in something that regulators are yet to form an opinion on. Therefore, the ability of regulators to keep pace with the industry is not only imperative for the timely implementation of newly developed scientific and technological advancements, but also for promoting future innovation and ambition within the sector.
