Identifying trials run in India, registered with ClinicalTrials.gov, is not straightforward

Clinical trial registries are invaluable resources for many stakeholders. However, these registries often require customized methodologies to identify studies of interest. To determine what steps it would take to catalog every trial that has run in India, in this study, we examined the records held by the registry of the United States, ClinicalTrials.gov. We utilized the Aggregate Analysis of ClinicalTrials.gov database, which draws data from ClinicalTrials.gov. Starting with 458,069 records, a shortlist of 11,439 records of interest was identified that contained the keywords 'India' or 'CTRI', the latter standing for Clinical Trials Registry-India. The Location field indicated that India had been a country of recruitment in 1,416 records. Other, non-obvious fields indicated that 52 records were concerned with trials in India. Among these, 35 cases used confirmatory language, and 17 cases had circumstantial evidence for the studies having run in India. It ought to be easier to unambiguously determine which countries a study has run in. Addressing this challenge is crucial for ensuring the accuracy, completeness, and transparency of clinical trial data, benefiting patients, healthcare providers, researchers, regulators, policymakers, and other stakeholders.