Two important reports have been released in the last week: Lord O’Shaugnessy’s report into commercial clinical trials in the UK and Dame Angela McLean’s review into pro-innovation regulation of technologies.
There are many very important recommendations in each paper which, if implemented, could have an incredibly positive effect on the industry.
Commercial clinical trials in the UK: the Lord O’Shaughnessy review – final report
Key recommendations:
- Develop and publish SMART (specific, measurable, achievable, relevant and time-bound) metrics for all the ambitions in the clinical research vision Saving and Improving Lives: The Future of UK Clinical Research Delivery, and subsequent implementation plans, with owners held to account for delivery by the Life Sciences Council.
- The Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA) and other system leaders should set up a rapid ‘task and finish’ group to produce a plan on reducing the regulatory burden of approving trials and removing delays in set-up, including with the goal of reaching a 60-day turnaround time for all approvals.
- Additional funding should be provided by the UK government to the regulators, the MHRA and the HRA, to rebuild capacity and deliver reduced turnaround time for all approvals.
- A comprehensive and mandatory national approach to costing and contracting should be developed and instigated, in partnership with industry.
- The MHRA, the HRA, the NIHR and its equivalent organisations should collect and publish national monthly returns on all the clinical trials activity that is happening in the NHS, and NHS bodies and commercial sponsors should publish numbers of patients in trials on a monthly basis.
- DHSC, the Department for Science, Innovation and Technology (DSIT) and the NHS should set stretching annual targets for increasing commercial trials in the 4 countries of the UK and carry out annual benchmarking exercises comparing performance against competitor countries. Central to this ambition should be the objective of doubling recruitment to commercial clinical trials within the next 2 years, with a further doubling by 2027.
- A statement should be made by the NHS leadership and ministers of the UK’s intention for the health service to be the world’s leading platform for health R&D, and annual R&D targets should be introduced for the NHS at every level.
- Income generated by commercial sponsors should be explicitly directed to units and departments leading trials in NHS sites to provide direct financial incentives to take part in commercial trials.
- The NHS should use the upcoming NHS Long Term Workforce Plan and UK Recovery, Resilience and Growth (RRG) Research Workforce Strategy to establish a Clinical Trials Career Path for training critical roles for research.
- All patients receiving genomic sequencing of any kind in the UK should be offered a standard consent for engaging in research.
- The NHS England Data for R&D Programme’s NHS Research Secure Data Environment Network should be rolled out, including urgent publication of guidance for NHS bodies on engaging in research with industry.
- Financial incentives should be introduced for GPs to take part in commercial trials.
- New primary care research networks should be introduced to increase the proportion of commercial trials taking place in primary care and ‘at home’ settings.
- Regulators should produce guidance to support and promote innovative and decentralised trials.
- An action plan should be published and reported on publicly every year.
The report also notes that there is a distinct lack of data around trials involving medical devices and the digital health sector as a whole, which means that value for money and excellence is hard to measure. This can also lead to under-rewarding overperformance and a lack of scrutiny of underperformance as well as selecting trial sites which are less than optimal.
The recommended new primary care research networks should link up relevant delivery organisations, such as community pharmacies, diagnostic providers, logistic firms and virtual care providers, with the aim of having one PCRN in every ICS or health board in the UK.
You can read the report in full here.
Pro-innovation Regulation of Technologies Review
Key recommendations:
- Creation of a skills pipeline across those regulators whose remits cover life sciences to build expertise in the long term, including through the use of industry secondments, Centres of Excellence in Regulatory Science and Innovation (CERSIs) and flexibility around pay scales.
- Recommendation to allow different parts of the regulatory system to share data on new technologies and applications.
- The government should invest in integrating cloud-based data platforms into the regulatory application system.
- As regulatory agencies return to business-as-usual following the pandemic there is a need for them to learn the lessons from that experience, refocus on day-to-day activities, ensure companies are kept updated on the progress of applications, and position themselves as thought leaders in the regulation of innovative new medical products.
- Regulators should be supported to engage with innovative technologies and deliver regulatory pathways that enable them to reach market through appropriate resourcing and sustainable funding.
- Regulators should set timelines to approval that are in line with international best practice for their sector to ensure that the UK remains globally competitive in their sector. They should take a proportionate approach at different stages of the regulatory pathway, while recognising this will vary between organisations and technologies. Speed and transparency are both important, so regulators should publish their expected response timelines in real time so that industry knows what to expect.
- Ensure the domestic routes for approval (of medicines and devices, including for AI) are predictable, transparent and proportionate. MHRA should be supported to deliver this and should convene a group of responsible organisations in the regulatory system to agree what products should go through innovative licensing pathways. For those novel products which will deliver transformative outcomes in areas of unmet clinical need, the system should collaborate to create an effective innovation pathway. This has already taken place for medicines in the form of ILAP (Innovative Licensing and Access Pathway), but there are key issues to be resolved. The work to create the same innovation route for medical devices (IDAP) should be progressed – learnings from ILAP must be implemented.
- Redefine a proactive partnership between the MHRA and the UK Approved Bodies, to act as dual gate keepers.
- Move to a system of early market access for MedTech where there is an unmet need or significant benefit to patients, combining better patient outcomes with the gain of vital data for full market access.
- Speed up the route to market for innovative products through the wider regulatory system by improving efficiency and enabling quicker decision-making on NICE approvals.
- NICE should consider how it can enable the innovation pathway by speeding up decisions that allow NHS adoption and reviewing its use of committee processes and consider the need for novel ways of working as a result of the move to recognition and reliance.
- Recommendation to enable a consent-based approach of sharing industry data between different bodies within the regulatory system to enable access to accelerated progress of applications through different regulators.
You can read the full paper here.
