Status of Registered Clinical Regulatory Trials of Non-communicable Diseases in the Pre- and Post-COVID-19 Era: A Web-Based Study

Introduction: Non-communicable diseases (NCDs) are a major global health burden and constitute the majority of all registered clinical trials.Clinical trials are vital for developing effective management strategies for NCDs.The COVID-19 pandemic significantly disrupted the conduct of clinical trials worldwide.This study aimed to compare the status of registered clinical regulatory trials for major NCDs in India and the USA before and after the pandemic.Methodology: A retrospective, web-based analytical study was conducted.Data were collected from CTRI (Clinical Trials Registry -India) and ClinicalTrials.gov(USA) for the following NCDs: diabetes mellitus, breast cancer, asthma, hypertension, chronic obstructive pulmonary disease (COPD), ischemic heart disease, and stroke across the pre-COVID (January 2018-January 2020) and post-COVID (June 2023-June 2025) periods.Pharmaceutical industry-sponsored, interventional drug trials with regulatory approval were included.Categorical variables were analyzed by the chi-square test and Fisher's exact test with odds ratios and 95% confidence intervals.Continuous variables were analyzed using the Mann-Whitney U test.The Benjamini-Hochberg procedure was applied to control the false discovery rate for multiple comparisons, and an adjusted p-value of <0.05 was considered statistically significant.Results: Total number of trials increased from 456 to 483 in the post-COVID period, with trials in India increasing from 95 to 141, while in the USA, they decreased slightly from 361 to 342.In India, trials for COPD increased significantly (p-value = 0.035), while trials for diabetes decreased significantly (p-value = 0.0063) in the post-COVID period.A significant decrease was seen in Phase 4 trials in the USA in the post-COVID period (p-value = 0.035).In the post-COVID period, in both countries, a significantly larger number of trials were open to recruitment and significantly fewer trials had recruitment closed.In the USA, there was a significant decrease in the number of terminated trials and trials with an unknown status.Additionally, trials in India had a significantly lower median number of study sites in the post-COVID period.Conclusion: Overall NCD trial numbers have largely recovered post-COVID.However, certain elements were impacted; for example, in India, trials for COPD showed a significant rise, while trials for diabetes declined significantly.Phase 4 trials declined significantly in the USA.Changes were seen in recruitment status in both countries, and the median number of study sites decreased significantly in India.