Barriers to health-care access amid the coronavirus disease 2019 pandemic in children with non-coronavirus disease illnesses from India

Background: Coronavirus disease 2019 (COVID-19) and the nationwide lockdown have resulted in profound disruptions in health care. Thus, the study was done to assess the barriers faced by caregivers of children with chronic diseases in accessing healthcare services due to the lockdown. Methods: A questionnaire-based telephonic survey was performed after 2 months of nationwide lockdown in children with chronic diseases at a tertiary hospital in India. Barriers faced were recorded and compared with the place of residence and socioeconomic status (SES). Results: A total of 101 children with mean ± standard deviation age of 9.7 ± 3.6 years and median (interquartile range) disease duration of 48 (12, 84) months were included. The majority (84.6%) was on daily therapy and 65.3% reported disrupted treatment. Patients residing away from the capital had greater difficulty in investigations and in transport to the hospital (P < 0.05) compared to those in the capital. Patients from lower SES had more difficulty in procuring medications (64.1% and 35.4%; P = 0.006), transport (62.3% and 29.1%; P = 0.003), and perceived significant effect of COVID-19 on their child (47.2% and 16.7%; P = 0.002) compared to middle SES. Conclusions: Disrupted health-care access during COVID-19 suggests the need for health-care systems to be better equipped to manage patients with chronic illnesses during such pandemics

A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials

Aim: This analysis was conducted to review the number, and describe the characteristics of first-in-human (FIH) Phase 1 clinical trials registered in India from 2008 to 2022. Materials and Methods: The data were extracted from the Clinical Trials Registry – India database for all FIH Phase 1 clinical trials registered between 2008 and 2022. Early-phase trials that were not FIH trials (e.g., pharmacokinetic studies and drug–drug interaction studies) were excluded from the study. Results: A total of 1891 trials were retrieved and 220 were included in the analysis. Most of the investigational products were drugs (55%) followed by vaccines (38.2%). The most common therapeutic class of drugs was cancer chemotherapy (19.8%), followed by antimicrobial chemotherapy and endocrinology (18.2% each). The most common vaccine was the influenza vaccine (21.4%), followed by the measles–mumps–rubella vaccine (15.5%). The pharmaceutical industry was the predominant sponsor for most (91%) of the Phase 1 trials. Of the top five sites where most of the Phase 1 trials were conducted, three were private nonacademic centers (cumulatively 31%) and two were tertiary care medical colleges (cumulatively 9%). Conclusion: Phase 1 clinical trials seem to be conducted in India predominantly with industry sponsorship. There is a need to have an alternate ecosystem to take forward molecules that do not receive adequate attention from the industry and molecules that are of national health priority other than areas such as chemotherapy, antimicrobials, and endocrinology. The Indian Council of Medical Research is setting up Phase 1 clinical trial capacity for molecules that predominantly may arise from nonindustry channels