Fiona Maini, principal, global compliance and strategy at Medidata, a Dassault Systèmes company, summaries recent important regulatory changes.
Over the past couple of years, clinical trials and the ways in which patients interact with them have evolved on a huge scale. Patients are more aware, technology-driven and informed; driving a change in mindset in the industry and helping to revolutionise the way clinical trials are approached and conducted.
As a result, the gap between scientific and technological advances and the mechanisms intended to regulate them has widened, as innovation outpaces the ability of lawmakers and regulators to keep up. The life sciences and healthcare sectors have, however, recognised that regulatory frameworks need to change and adapt to ensure the industry can benefit fully from technological advances, while still protecting patients and public health. With this in mind, what regulatory changes have we seen over recent months and what areas should we be keeping an eye on?
Encouraging innovation while addressing challenges posed by artificial intelligence
Back in August 2021, the International Coalition of Medicines Regulatory Authorities (ICMRA) set out new recommendations aimed at helping healthcare watchdogs as they begin to scrutinise the use of artificial intelligence in the sector and bring AI into the scope of their regulatory frameworks. It is hoped that strong, clear, and sensible rules governing the use of AI in medicines development will give all stakeholders in the industry the confidence to expand their use of artificial intelligence to find new drugs, for the benefit of patients. Some of ICMRA’s main findings included: the need for regulators to use a risk-based approach when assessing and regulating AI; sponsors, developers and pharmaceutical companies should establish stronger governance frameworks to oversee algorithms and AI deployments closely linked to the benefit/risk of a medicinal product; and fresh regulatory guidelines for the development, validation and use of AI with medicinal products in areas such as data provenance, reliability, transparency, and the real-world monitoring of patients.
The ICMRA is due to discuss how these recommendations should be implemented over the coming months, which will allow regulators to assess the limitations of existing systems and adapt them if necessary. It will be interesting to see what these new recommendations mean in practice, and specifically how the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will respond and adapt its own regulations to include AI within its rules.
The European Commission recently released its AI Act, highlighting the need for an effective AI assurance ecosystem. This is the world’s first legal framework for the use of AI, which lays out a set of regulations to ensure the ethical use of AI within the EU.
Streamlining clinical trial approvals
Meanwhile, at the end of January, the European Union (EU) introduced the Clinical Trials Regulation (CTR); the overarching aim of which is to ensure that the EU offers an attractive and favourable environment for large-scale clinical research, whilst maintaining high standards of public transparency and safety for trial participants. The most significant and obvious benefit of the CTR is the harmonisation of the assessment and supervision of clinical trials throughout the EU.
Previously, sponsors wishing to run pan-EU trials would have to submit separate clinical trial applications to regulatory authorities and ethics committees in each country to gain the necessary regulatory approval to run a trial. As a result, there should be a noticeable shift over the next few years towards a more streamlined approach to the way in which clinical trials are planned and conducted across the EU, which is likely to lead to more large-scale trials being conducted across the continent, allowing more patients to participate in clinical trials.
Regulation after Brexit - strengthening the UK’s systems
For those in the UK, one of the most significant recent developments is the launch of the MHRA’s public consultation on proposals to improve and strengthen the UK’s clinical trials regulations, specifically the Medicines for Human Use (Clinical Trials) Regulations (2004). The legislative proposals outlined in the consultation, which closed earlier this month, aim to streamline clinical trial approvals, enable innovation, enhance transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials. Since the UK’s departure from the EU, the MHRA has had to equip itself for a future outside of the European Medicines Agency (EMA)’s jurisdiction, providing it with an opportunity to showcase its ability to work alongside the industry to drive innovation and reform – in line with the UK government’s vision. This has been described as a “once-in-a-generation” opportunity to update the UK’s clinical trials regulation – and it will be interesting to see just how far these reforms go.
Hopefully, they will help to drive technological change in clinical trials through helping to facilitate and encourage a shift away from more ‘traditional’ ways of approaching clinical trials to decentralised clinical trial (DCT) models. The unveiling of this new consultation follows the launch of the MHRA’s Delivery Plan for 2021-2023, announced last year. This presented an incredibly bold and progressive outlook from the regulator, in which it committed to creating new regulatory frameworks, developing the use of Patient Reported Outcome Measures to make patient outcomes more central to clinical trials, and rolling out new patient engagement activities. This should help to ensure that trials work in harmony with patients’ lives; offering them more flexibility in how and when they engage with clinical trials and ensuring that they feel supported throughout the journey.
Additionally, the UK launched the Innovative Licensing and Access Pathway (ILAP) last year, a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. The pathway involves an Innovation Passport designation, a Target Development Profile and provides applicants (UK based or global) with access to a toolkit to support all stages of the design, development and approvals process of new drugs and treatments.
Balancing patient centricity, innovation, and regulatory changes
The next 12 months will be an important test to see how these regulations come to fruition, and what these changes mean in practice for the sector. The industry has already been putting patient centricity and innovation at the front and centre of its processes; and these new regulations should work in tandem with initiatives currently in place to provide a more harmonised approach across the sector.
Regardless of the approach to clinical trials (be it a traditional method or a DCT), regulators have the safety of individuals and public health as foundations. The pace of technological change is continuously accelerating, so having regulators invest time in understanding and embracing innovation will continue to be important going forward. This will allow them to continue to protect patients and public health, whilst also ensuring that innovation is not stifled. If regulators continue to show pragmatism and a willingness to engage with all relevant industry stakeholders; then the life sciences and healthcare sector will continue to thrive, advance, and keep patient centricity at its heart.
