Regulations on radiation exposure have been a critical bottleneck in starting up new cancer trials, but now radiation experts from the Experimental Cancer Medicine Centre (ECMC) network – a joint initiative between Cancer Research UK and the UK’s four health departments – are pioneering a new streamlined system to reduce the time taken to set up clinical trials involving radiotherapy and other forms of ionising radiation, such as PET scans.
“We’re delighted that our Experimental Cancer Medicine Centres network has been able to support this important initiative to streamline the regulation of clinical research, so patients can continue to reap the benefits from the world-class research taking place throughout the UK.” – Prof Peter Johnson, Cancer Research UK
The new system has been drawn up by leading experts from across the medical physics and clinical radiology communities. It provides a standardised way of assuring that exposure to ionising radiation during clinical trials remains within safe limits, while also cutting down dramatically on duplication of work.
All new trials involving exposure to ionising radiation across the ECMC network will now use the new system, as part of a collaboration with the Health Research Authority (HRA) to begin rolling out HRA Approval, the new single approval system for health research in the NHS in England.
Giles Morrison, head of radiology physics at Sheffield Teaching Hospitals NHS Foundation Trust, who was involved in the consultation process, said: “It’s wonderful to see the medical physics and clinical radiology communities working together to improve the way in which radiation exposure reviews are carried out within clinical trials.
“This will mean patients getting new treatments sooner. We’re still working on the detail and I hope all ionising radiation experts will give their views to ensure that the process is the best it can be.”
Greg Trevelyan, head of the UK Study Start Up Group at Roche, who are sponsoring an immunotherapy trial in patients with triple negative breast cancer, one of the first ECMC trials to undergo the new system, said: “Roche embraces initiatives that have a commitment to deliver early treatment access, whilst maintaining patient safety. As the leading pharmaceutical investor in R&D, Roche is dedicated to working with our industry colleagues in streamlining how clinical trials are set up and conducted in the UK. Above all, this new standardised system will mean any radiology issues are picked up early and provide sponsors with a single point of contact for resolution. We are delighted to be working with Cancer Research UK and the UK health departments on this initiative.”
The ECMC network is also working with the HRA to pioneer a new system that allows a single designated pharmacist to review the pharmacy requirements of a clinical trial, rather than conducting multiple independent reviews at each participating hospital.
Both schemes will form part of the new HRA Approval process, which will be implemented in stages, by study type, during the course of 2015, streamlining the approvals process for research taking place within the NHS.
Professor Peter Johnson, Cancer Research UK’s chief clinician, said: “We’re delighted that our Experimental Cancer Medicine Centres network has been able to support this important initiative to streamline the regulation of clinical research, so patients can continue to reap the benefits from the world-class research taking place throughout the UK.”
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How will the new system work?
Coordinated radiation assurance will be managed centrally by the HRA. The 18 ECMCs will be asked to allocate ionising radiation experts (MPEs and CREs) to act as reviewers. Once a project has been identified as appropriate, the HRA will work with the submitter to complete a Research Exposure Form, this summarises the information contained in the protocol and is the basis for all further reviews. The Research Exposure Form will then be sent together with the Participant Information Sheets and Protocol to the expert reviewers (MPE and CRE). The expert reviews will be uploaded onto the Integrated Research Application System (IRAS) form and the MPE and CRE signatures can then be requested.
Full details of the new system may be obtained from the HRA by emailing [email protected]
More on the HRA Approval
HRA Approval is the new approval that will be required for research to commence in the NHS in England. It is a new process that comprises a review by a Research Ethics Committee as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. HRA has an ambition to implement HRA Approval for all types of health research by December 2015. Implementation will be in a controlled roll out by study type
- Researchers will benefit from HRA Approval through the elimination of duplicate application routes and paperwork, enabling them to work on establishing research sites, recruiting participants and completing studies on time.
- Patients will benefit from HRA Approval through earlier opportunities to participate in studies and through more efficient and effective research leading to improved treatments and care.
- Industry will benefit from more joined-up access to NHS sites for research, making the UK a more attractive place for health research.
- HRA Approval will provide the platform for delivering the EU clinical trials regulations, ensuring the UK is ready and prepared and Industry can plan to place studies in the UK with continued confidence in UK readiness
- HRA Approval applies for all study types in the NHS in England .
- Health research falling under other specific legislation will still need approvals from other Regulators, these will continue to be coordinated within an overall UK wide framework for research in the UK
Further details of the HRA Assessment and Approval can be found at: http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment-approval/ (link is external)
