Full government response to the Lord O'Shaughnessy review into commercial clinical trials
The government published their full response to the Lord O’Shaughnessy commercial clinical trials review on the 22nd November - you can read the full response on the government site here.
Published in May 2023, the O’Shaughnessy review identified many challenges facing commercial clinical trials within the UK and outlined multiple recommendations on how to address them. The government responded initially to confirm that all the recommendations were welcomed, and committed to 5 headline initial commitments (see here for the detail).
The full government response obviously goes much further than the interim response, expanding on work that has already been undertaken, and also on the future actions that will be delivered to tackle the challenges within the current system. This includes:
New Clinical Trial Delivery Accelerators (CTDAs). Lord O’Shaughnessy’s report recommended the creation of clinical trial acceleration networks (CTANs). Following consultation by the government as part of developing this response, the name has been modified to better represent what the CTDAs will aim to achieve. £20m has been committed to funding these new models. (See section 1.6 in the response for the full detail of what the CTDAs will be working on).
New key performance indicators (KPIs) are being implemented with immediate effect - a full list of these is provided in the response (tables 1-4, section 2.1).
A commitment to ‘drive forward activity to streamline and speed up the delivery of innovative clinical studies’. This includes the continued development of IRAS by the HRA and the implementation of new clinical trials legislation (though there are no fixed timelines for either of these actions).
A commitment to collect, consolidate, and publish national data on ongoing clinical research. A dashboard of research system metrics will be available from Spring next year. A project is also underway to develop an entirely new system for capturing and sharing clinical trial data.
DHSC will develop a workforce plan for clinical research.
WFC are continuing to work on projects supporting the development and implementation of solutions to tackle the challenges identified by the O’Shaughnessy report, including our current work with the ECMC Network delivering improvements for the set-up of early-phase cancer trials (as part of the UK Clinical Research Recovery, Resilience, and Growth Programme; the full government response was developed by the RRG Programme).
Multiple groups and organisations have published responses to the full government publication, we have listed them here: