Abstract
IntroductionThe current study was aimed at quantifying the disparity in geographic access to cancer clinical trials in India.MethodsWe 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.ResultsWe 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).ConclusionThere are significant geographic disparities in access to cancer clinical trials in India. Future investigations should evaluate the reasons and mitigation approaches for such disparities.
Highlights
The current study was aimed at quantifying the disparity in geographic access to cancer clinical trials in India
Even in the state with the highest size per state per year (SSY), only 29.7% of the newly diagnosed cancer cases have an available slot in a therapeutic cancer clinical trial
Disparities in access were apparent between academic and industry-sponsored trials
Summary
The current study was aimed at quantifying the disparity in geographic access to cancer clinical trials in India. Geographical access to a clinical trial may impact recruitment into clinical trials. The disparity in access to cancer clinical trials is magnified in lower-middle-income countries (LMIC) [7]. As opposed to nearly 4,700 cancer clinical trials in breast, lung and cervical cancers in high-income countries, there were only 1,951 clinical trials available in LMIC nations [7]
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