Radiation Assurance is a UK-wide process fully managed by the HRA on behalf of the four nations. Following a pilot period, phase one of Radiation Assurance was launched in April 2018 to accept all oncology studies taking place in the NHS.
Phase two of Radiation Assurance was launched in November 2018 to accept studies in the fields of cardiology, neurology and rheumatology.
Ahead of the roll-out of phase three later this year, where all other NHS studies involving ionising radiation will be accepted for Radiation Assurance, here’s how the process works in practice.
What is Radiation Assurance?
The process clarifies the information regarding research radiation exposures in study documentation at an early stage in the research regulatory approvals pathway. It also coordinates the lead Clinical Radiation Expert (CRE) and lead Medical Physics Expert (MPE) reviews in Part B section 3 of the Integrated Research Application System (IRAS) application form.
Applicants have the option of allowing the HRA to manage the review of their submission (HRA-managed), or to manage the review of their application themselves (self-managed).
A detailed overview of the process is available on our Applying for Radiation Assurance page.
Led by the Barts ECMC (Experimental Cancer Medicine Centre) at Queen Mary University London, the BARBICAN study is a randomised drug trial involving women with triple negative breast cancer – a rarer type of breast cancer affecting around 20 per cent of cases.
The phase II study is targeting around 142 patients in three countries.
Chemotherapy is the current standard treatment for triple negative breast cancer, though results remain relatively poor compared to other types of the disease.
The BARBICAN study
The BARBICAN study aims to investigate the effect of adding a new drug (ipatasertib) to chemotherapy before surgery and the drug atezolizumab. It will do this by looking at whether the combination of these treatments can remove any evidence of cancer by the time a patient has their surgery. The drugs have different targets and there is evidence that they can work together to control cancer growth.
Kelly Mousa, from the Barts ECMC at Queen Mary University of London, which is affiliated with Bart’s Health NHS Trust worked with Kirstie Penman, Technical Assurances Officer from the Health Research Authority on the Radiation Assurance review which was completed in 25 days.
Kelly Mousa, who leads the trials team operations at Barts ECMC“As an ECMC our team was given the opportunity to work with HRA Radiation from its pilot phase in 2015. Since then all our studies have been reviewed via this scheme and the experience has been professional, consistent, timely and to a good standard. The reviews have also been well accepted by all UK sites participating in our studies. Streamlining the process though a central contact and inbox, has also taken a lot of the burden away from the research teams. Reviewers are quickly identified, and we are always kept up date on progress. Overall it has been a very positive experience for our centre.”
Kirstie Penman, Technical Assurances Officer from the Health Research Authority“Now the applicants simply email the Radiation Assurance inbox at hra.radiationassurance@nhs.net and provide a draft copy of the IRAS form, as well as a copy of the protocol and imaging manual, if this is available. Applicants then also provide copies of relevant patient information sheets and a document developed by the HRA called a Research Exposure Form, which clearly summarises the number and types of exposures required for a study.”
Kelly Mousa, who leads the trials team operations at Barts ECMC“We have a portfolio of early phase oncology trials and most of our trials use imaging e.g. CT or PET scans to assess how well a treatment is working. This means that all our studies will have to have Radiation Assurance before we can seek ethical review and ultimately HRA approval. We’re keen to continue using the Radiation Assurance - it’s a fantastic service.”