Dr Janet Messer welcomes the vision for the future of clinical research in the UK
Colleagues and I at the HRA, other regulators, research sponsors, government and the NHS have brought together much learning and experience from work during the COVID-19 pandemic and coordinated many great initiatives already started in research systems across the UK.
One of the themes of the vision is around better use of data and digital tools to support the efficient delivery of clinical research. For the HRA this means making it easy for researchers to carry out responsible research that complies with legal and ethical expectations; and easy for patients and the public to access research with lay-friendly information about the results. We are building new IRAS functionality which interacts with other systems - creating one seamless online resource for applicants. IRAS will support researchers through the ideal path for setting up their study and continue throughout the lifecycle of their project across all the relevant organisations, truly providing a single, coordinated and collaborative system for the UK.
Our expertise in the use of data in research will also support the development of digital tools that enable the identification and recruitment of research participants in ways that respect confidentiality.
The vision acknowledges the need to improve the speed and efficiency of study set up. We are already hard at work building on lessons learnt from COVID-19 to harness the opportunity to develop a single national approach to prioritisation, standardisation and coordination of clinical research. We know that improving study set-up and delivery in the NHS is really important to companies placing studies in the UK. We already provide a range of template agreements for use between sponsors and NHS sites. We are now working collaboratively with National Institute for Health Research (NIHR), the devolved administrations and NHS England and Improvement to improve the speed and consistency of price negotiation for clinical trials.
We’ve piloted a fast-track ethics review for non-COVID clinical trials of medicines, showing that we can provide a decision 50% faster than usual. We’re now continuing that service while we evaluate the pilot. We will also explore how a fast-track ethics review can be incorporated into wider rapid approval and study set-up processes. This includes integration into the combined review with the Medicines and Healthcare products Regulatory Agency (MHRA), which offers a single application, combined review and decision for a clinical trial. This will also support MHRA’s Innovative Licencing and Access Pathway (ILAP). The ILAP aims to accelerate the time to market, facilitating patient access to medicines, by bringing together innovative approaches to support the safe, timely and efficient development of innovative products.
These are just a few examples of how we’re using our experience of reviewing and approving urgent COVID-19 research to help rebuild a strong research environment and ensure that the UK maintains its world-leading reputation for health and social care research.