Delivery of radiotherapy clinical trials: Recommendations for best practice across Clinical Trial Units (CTU) and the National Radiotherapy Trials Quality Assurance Group (RTTQA)


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Lisette Nixon1,Elizabeth Miles2,Natalie Abbott3,Sue Bell4,Clare Cruickshank5,Patty Diez6,Alexandra Smith4,Yat Tsang6,Emma Hall5,on behalf of CTRad7
1Cardiff University, Cardiff, UK,2Coordinator National Radiotherapy Trials QA (RTTQA) Group, London, UK, Mount Vernon Cancer Centre, Northwood, UK,3Velindre Cancer Centre, Cardiff, UK,4University of Leeds, Leeds, UK,5The Institute of Cancer Research, London, UK,6Mount Vernon Cancer Centre, Northwood, UK,7National Cancer Research Institute, London, UK

Abstract

Background

Radiotherapy delivery within multicentre clinical trials should be consistent and in accordance with the protocol.   Evidence shows poor protocol adherence affects outcomes and therefore the interpretation, credibility and impact of trial results. The NIHR funded National Radiotherapy Trials Quality Assurance (RTTQA) group monitors radiotherapy quality in NIHR CRN portfolio trials. A standardised approach to partnership working between NCRI Cancer Clinical Trials Units (CTUs) and the RTTQA group supports efficient development and delivery of radiotherapy trials. The NCRI Clinical and Translational Radiotherapy Research Working Group (CTRad) recognised that a consistent approach to CTU-RTTQA collaboration is needed and tasked a working group to develop comprehensive guidance.

Method

A working group was convened from CTRad members to promote closer working relationships between RTTQA and CTUs through shared working practices and experience. Using the Clinical Trials ToolKit as a prompt, key tasks were identified and roles and responsibilities for both stakeholder groups proposed.

Results

Recommendations for best working practice were developed for dissemination to all CTUs managing radiotherapy trials. Areas for collaborative working during study development (pre-funding award), protocol development (post-funding award), pre-accrual trial set up and during- and post-accrual were identified.  

On confirmation of study funding RTTQA will work with the protocol development group/trial management group to agree the RTQA programme. RTTQA will lead the radiotherapy guidelines development (to supplement the trial protocol) and support radiotherapy focussed training/education. CTUs will ensure the guidelines and protocol are consistent and oversee document version control/amendments during the trial.

Proactive engagement between CTUs and RTTQA was highlighted as a key component of this partnership ensuring efficient and effective delivery of clinical trials.

Conclusion

The RTTQA group and CTUs are key partners in radiotherapy clinical trials. Common working practices underpinned by good communication and an understanding of roles and responsibilities facilitate efficient trial set up and delivery.