Clinical vacancies in the UK in 2023 are predicted to be 35% lower than volumes experienced in 2022. These falls are to the most part in line with general trends in industry vacancy landscape which has experienced a significant drop (-33.3%.).
However, out of greater kilter and significant is the final quarter of this year for clinical positions where recruitment has dropped to levels not seen in the last five years, when viewed in through the prism of one quarter. What is of ongoing concern has been the backlog of clinical trial applications at the U.K. Medicines and Healthcare products Research Agency (MHRA) and the impact this has in discouraging companies from conducting studies in the UK.
In response, the MHRA is actively addressing the issue by increasing recruitment and training of assessors, improving the capabilities of existing staff, and prioritizing the clearance of the backlog, particularly around population health. The MHRA is also working on providing more predictability by publishing performance data on different application types. A further interesting development at MHRA was the appointment of a Head of AI to enhance efficiency and explore the use of artificial intelligence in expediting the assessment process. While AI will assist assessors in processing information more efficiently, it will not replace human decision-making. Additionally, the MHRA is developing an international recognition framework to acknowledge regulatory decisions from countries beyond the EU, such as the US, Canada, Switzerland, Singapore, Japan, and Australia. This framework aims to avoid duplication of efforts and promote mutual recognition and harmonisation of regulatory frameworks globally.
Despite these efforts, close collaboration between the MHRA and industry stakeholders is crucial in addressing the challenges posed by post-Brexit regulatory shortages and delays. Timely and transparent communication, sharing best practices, and leveraging international partnerships can help navigate these challenges more effectively. The industry must actively engage with the MHRA, providing valuable insights and support to streamline processes and ensure the timely availability of safe and effective medical products in the UK market. It is also important for businesses to accurately complete their applications to avoid challenges or rejections.
While regulatory shortages and delays present challenges, the MHRA remains committed to overcoming them through strategic measures, AI integration, and the international recognition framework. The agency aims to streamline processes, enhance efficiency, and achieve global harmonization. Active industry engagement and collaboration with the MHRA are key to driving positive change in the regulatory landscape during this transition period.
Yvette Cleland - CEO | Cpl Life Sciences
