Over the last two years, clinical trials and the way patients handle them have improved significantly. Patients are better informed, technology driven and informed; promotes a change of mindset in the industry and helps change the way clinical trials are approached and conducted.

As a result, the gap between scientific and technological progress and the mechanisms to regulate it is widening, as innovation has increased the ability of legislators and supervisors to maintain it. However, the life sciences and health sectors recognize the need to review and adapt regulatory frameworks to ensure that industry can fully benefit from technological progress while still protecting patients and public health.

Given the regulatory changes we have seen in recent months and what areas do we need to be careful about? 

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 has recently approved its AI law, which emphasizes the need for an efficient AI insurance ecosystem. It is the first legal framework for the use of artificial intelligence in the world and describes a set of rules to ensure the ethical use of artificial intelligence within the EU.

Streamlining clinical trial approval

Meanwhile, the European Union (EU) introduced the Clinical Trials Regulation (CTR) at the end of January; its overall aim is to ensure that the EU provides an attractive and favorable environment for large-scale clinical research, while maintaining high standards of public transparency and security for trial participants. The most important and obvious advantage of CTR is the harmonization of evaluation and management of clinical trials in the EU.

Previously, sponsors who wanted to conduct Europe-wide studies had to submit separate clinical trial applications to each country's regulatory authorities and ethics committees in order to obtain the necessary regulatory approval to conduct the test. As a result, there should be a significant shift towards a streamlined approach to the way clinical trials are planned and conducted in the EU in the coming years, which is likely to lead to more trials in the EU. continent, allowing more patients to participate in clinical trials.

Regulation after Brexit - strengthening of British systems

For those in the UK, one of the key innovations is the launch of a public consultation of the MHRA on proposals to improve and strengthen the UK Clinical Trials Regulation, in particular the Regulation.

The legislative proposals outlined in the consultation, which concluded earlier this month, aim to streamline the approval of clinical trials, create innovations, improve transparency, create a greater balance of risks and improve patient and public participation in clinical trials. Since leaving the UK from the EU, the MHRA has had to prepare for a future outside the jurisdiction of the European Medicines Agency (EMA), giving it a chance to demonstrate its ability to work with industry to support innovation and reform. - in line with the British Government's vision.

It has been described as an opportunity "once a generation" to update the UK clinical trials scheme - and it will be interesting to see how far these reforms go. Hopefully, they will help drive technological innovation in clinical trials by helping to facilitate the transition and by promoting "more traditional" ways of accessing clinical trials to decentralized models. clinical trial (DCT).

The launch of this new consultation follows the launch of the MHRA 2021-2023 delivery plan, which was announced last year. It demonstrates the supervisor's unique bold and progressive perspective, where he is committed to creating new regulatory frameworks that improve the use of patient-reported measurement results so that patient outcomes are clinically central. This should help ensure that the tests work in accordance with patients' lives; which gives them more flexibility in how and when they participate in clinical trials, and they feel encouraged along the way.

In addition, the United Kingdom last year launched the Innovative Licensing and Access Pathway (ILAP), a new pathway that supports new approaches to safe, timely and effective drug treatment to improve accessibility. The journey includes an innovation passport label, a development profile and provides applicants (based in the UK or worldwide) with access to a set of tools to support all stages of the design, development and development process. approval of new drugs and treatments.

Balance patient centrality, innovation and regulatory change

The next 12 months will be an important test to see how these regulations are complied with and what these changes mean in practice for this sector. Industry already puts patience and innovation at the forefront and center of its processes; and these new regulations should work with ongoing initiatives to ensure a more consistent approach in the sector.

Despite the method of clinical trials (or traditional procedures such as DCT), supervisors have individual safety and public health as a basis. The pace of technological change is accelerating, so having superiors who invest time in understanding and embracing innovation will continue to be important.

This allows them to continue to protect patients and public health while ensuring that innovation is unstoppable. As supervisors, they constantly demonstrate pragmatism and a willingness to deal with all relevant stakeholders in the industry; then the life sciences and healthcare sector will continue to grow, develop and remain the center of the patient's heart.