Title: Leeds Clinical Trial Unit Fellowship - developing a future interventional radiotherapy clinical trialist
Funder: Cancer Research UK

Abstract: Background: Radiotherapy is used in over 40% of patients treated curatively for their cancer. However, there is currently a lack of chief investigators (CIs) of radiotherapy trials in the UK and an urgent need to develop the CIs of the future. Radiotherapy clinical trials evaluate complex interventions (trials assessing interventions with multiple interacting components). The clinical trial design requires examination of radiotherapy quality assurance, radiobiological modeling, imaging, and consideration of protocol-adherance, centre and operator factors. Rigorous training in complex intervention trial methodology as well as expertise in precision radiotherapy, novel agents combinations, long-term toxicity outcome measurement and predictive biomarkers for personalization/stratification of treatment are key skills required. This fellowship is developed for an ideal, enthusiastic candidate (AG) with a strong background in toxicity outcome measurement, complex intervention design and predictive biomarker toxicity modelling linking PRO toxicity and radiotherapy dose data. This CRUK Clinical Trials Fellowship provides her with an excellent bespoke training programme to develop into a future radiotherapy interventional clinical trialist. Leeds CTRU is the best place to support this fellowship - aligning with the recent Leeds CTRU core funding for radiotherapy trial development, and CRUK ART NET accelerator award to optimise novel radiotherapy interventions/technology. It is in alignment with CRUK and national radiotherapy strategy (CTRad). Aims: The main aims of the fellowship are to develop expertise in novel radiotherapy interventions and complex intervention trial design and methodology; to develop, lead and progress clinical projects and trials in CTRU with a focus on new radiotherapy techniques and novel agent combinations, supported by ongoing involvement in international and national committees. Methods: A 3-year fellowship is proposed consisting of three key elements: formal and practical clinical trials research and training within CTRU, development of proposed fellowship projects and grant applications within CTRU as a joint lead-applicant with experienced clinical trialists, and further formal training in complex intervention trial methodology, translational research, and statistical analysis. Results: The primary outcome will be the provision of specialist training to develop a future radiotherapy interventional clinical trialist; providing a unique combination of practical radiotherapy clinical trials experience and training in complex intervention trial methodology. Secondary outcomes will include co-lead author publications; co-leading the submission of two grant applications evaluating novel approaches to treatment stratification and novel technologies; leading on guidance to optimise long-term toxicity measurement; and development of novel strategies to disseminate clinical trial results to the public through collaboration with consumer and charity groups.

Lay abstract: Background: Radiotherapy is used in over 40% of patients treated curatively for their cancer. However, there is currently a lack of chief investigators (CIs) of radiotherapy trials in the UK and an urgent need to develop the CIs of the future. Radiotherapy clinical trials evaluate complex interventions (trials assessing interventions with multiple interacting components). The clinical trial design requires examination of radiotherapy quality assurance, radiobiological modeling, imaging, and consideration of protocol-adherance, centre and operator factors. Rigorous training in complex intervention trial methodology as well as expertise in precision radiotherapy, novel agents combinations, long-term toxicity outcome measurement and predictive biomarkers for personalization/stratification of treatment are key skills required. This fellowship is developed for an ideal, enthusiastic candidate (AG) with a strong background in toxicity outcome measurement, complex intervention design and predictive biomarker toxicity modelling linking PRO toxicity and radiotherapy dose data. This CRUK Clinical Trials Fellowship provides her with an excellent bespoke training programme to develop into a future radiotherapy interventional clinical trialist. Leeds CTRU is the best place to support this fellowship - aligning with the recent Leeds CTRU core funding for radiotherapy trial development, and CRUK ART NET accelerator award to optimise novel radiotherapy interventions/technology. It is in alignment with CRUK and national radiotherapy strategy (CTRad). Aims: The main aims of the fellowship are to develop expertise in novel radiotherapy interventions and complex intervention trial design and methodology; to develop, lead and progress clinical projects and trials in CTRU with a focus on new radiotherapy techniques and novel agent combinations, supported by ongoing involvement in international and national committees. Methods: A 3-year fellowship is proposed consisting of three key elements: formal and practical clinical trials research and training within CTRU, development of proposed fellowship projects and grant applications within CTRU as a joint lead-applicant with experienced clinical trialists, and further formal training in complex intervention trial methodology, translational research, and statistical analysis. Results: The primary outcome will be the provision of specialist training to develop a future radiotherapy interventional clinical trialist; providing a unique combination of practical radiotherapy clinical trials experience and training in complex intervention trial methodology. Secondary outcomes will include co-lead author publications; co-leading the submission of two grant applications evaluating novel approaches to treatment stratification and novel technologies; leading on guidance to optimise long-term toxicity measurement; and development of novel strategies to disseminate clinical trial results to the public through collaboration with consumer and charity groups.

Research activity codes: 4.5 RESOURCES AND INFRASTRUCTURE (DETECTION);6.9 RESOURCES AND INFRASTRUCTURE (TREATMENT EVALUATION)
Health categories: CANCER AND NEOPLASMS