Abstract
INTRODUCTION: The current study was aimed at quantifying the disparity in geographic access to cancer clinical trials in India. METHODS: We collated data of cancer clinical trials from the Clinical Trial Registry of India and data on state-wise cancer incidence from the Global Burden of Disease Study. The total sample size for each clinical trial was divided by the trial duration to get the sample size per year. This was then divided by the number of states in which accrual was planned to get the sample size per year per state (SSY).For interventional trials investigating a therapy, the SSY was divided by the number of incident cancers in the state to get the SSY per 1,000 incident cancer cases. The SSY data was then mapped to visualise the geographical disparity. RESULTS: We identified 181 ongoing studies, of which 132 were interventional studies. There was a substantial inter-state disparity-with a median SSY of 1.55 per 1,000 incident cancer cases (range 0.00-296.81 per 1,000 incident cases) for therapeutic interventional studies. Disparities were starker when cancer site-wise SSY was considered. Even in the state with the highest SSY, only 29.7% of the newly diagnosed cancer cases have an available slot in a therapeutic cancer clinical trial. Disparities in access were also apparent between academic (range: 0.21-226.60) and industry-sponsored trials (range: 0.17-70.21). CONCLUSION: There are significant geographic disparities in access to cancer clinical trials in India. Future investigations should evaluate the reasons and mitigation approaches for such disparities.