METHODS AND MATERIALS: This retrospective cohort study identified all phase three RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiotherapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources.
RESULTS: The study cohort included 694 RCTs of which 64 were radiotherapy RCTs (9%) compared to 601 (87%) systemic therapy RCTs. 47% of all radiotherapy RCTs focused on two areas of evaluation; combining radiotherapy with systemic agents (25%) and changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%) and breast (14%) with cervical cancer trials only representing 3% of the cohort. 33% of radiotherapy RCTs met their primary end point. 62% of radiotherapy RCTs assessed interventions in the curative setting compared to 31% in systemic therapy RCTs. 77% of the radiotherapy RCTs were performed in high-income countries (HIC), 13% in low-and-middle-income countries (LMIC) and 11% in both HIC and LMICs. 17% of radiotherapy RCTs received funding from industry compared to 79% of systemic therapy RCTs.
CONCLUSION: This study has highlighted the need for greater investment in radiotherapy RCTs and the disparities in conduct of RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in LMICs and more sustainable funding sources.
METHODS: ARCHERY is a non-randomised prospective study to evaluate the quality and economic impact of AI-based automated radiotherapy treatment planning for cervical, head and neck, and prostate cancers, which are endemic in LMICs, and for which radiotherapy is the primary curative treatment modality. The sample size of 990 patients (330 for each cancer type) has been calculated based on an estimated 95% treatment plan acceptability rate. Time and cost savings will be analysed as secondary outcome measures using the time-driven activity-based costing model. The 48-month study will take place in six public sector cancer hospitals in India (n=2), Jordan (n=1), Malaysia (n=1) and South Africa (n=2) to support implementation of the software in LMICs.
ETHICS AND DISSEMINATION: The study has received ethical approval from University College London (UCL) and each of the six study sites. If the study objectives are met, the AI-based software will be offered as a not-for-profit web service to public sector state hospitals in LMICs to support expansion of high quality radiotherapy capacity, improving access to and affordability of this key modality of cancer cure and control. Public and policy engagement plans will involve patients as key partners.