Combined review with the Medicines and Healthcare products Regulatory Agency (MHRA) is now the way all sponsors and applicants seek approval for new Clinical Trials of Investigational Medicinal Products (CTIMPs). Trials submitted through combined review after 1 January will be automatically registered on ISRCTN Registry when given full approval.
Combined review – streamlining applications and reducing time
Combined review offers CTIMP applicants and sponsors a single application route and a joined up review, leading to a single UK decision in a faster overall timeline than the previous separate process.
Combined review should now be used for all new CTIMP and combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials). Information, guidance and support to get started is available on the combined review pages of the HRA website.
We’re holding a series of free, live webinars to help you prepare for combined review. If you’re an applicant, sponsor or you host CTIMP studies at your site, join us! Find out more and book a place for one of our January sessions. Recordings are available if you can’t attend.
Automatic registration - reducing the burden
All clinical trials must register with a World Health Organisation (WHO) recognised registry before the first participant is recruited to a study, but our recent audit shows that more than 10 per cent fail to do so. From 1 January 2022 trials submitted through combined review will be automatically registered on ISRCTN Registry when given full approval. This is free of charge and saves study teams time.
There’s more information about automatic registration on our website and questions and answers on our ISRCTN Registry partnership page. If you still have questions, contact deferrals@hra.nhs.uk
Saving and Improving Lives
The Future of UK Clinical Research Delivery sets out a vision for a patient-centred, pro-innovation and data-enabled clinical research environment, which empowers everyone across the health service to participate in delivering research and enables people across the country to take part in research.
We’re part of the UK-wide Clinical Research Recovery Resilience and Growth (RRG) programme, which brings together partners from across the NHS, government, research organisations, academia, regulators, medical research charities, industry, patients and the public to make it happen, and our work to streamline applications and improve transparency is key to achieving the vision.
This work forms part of the seven actions of the plan. There is more on the vision and its implementation on the Saving and Improving Lives website.