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Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines [ 1 ] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India .
In January 2021, the Drugs Controller General of India (DCGI) granted permission to conduct the Phase III clinical trials for 28,216 Indian participants in the 12–99 age group. [15] [16] Of this, about 1,000 individuals were in the 12–18 age group. [17] [18] Interim results from the phase III trials were made available in July 2021. [19]
According to a tracker of clinical trial progress on potential therapeutic drugs for COVID-19 infections, 29 Phase II–IV efficacy trials were concluded in March 2020 or scheduled to provide results in April from hospitals in China – which experienced the first outbreak of COVID-19 in late 2019. [19] Seven trials were evaluating repurposed ...
The first cases of COVID-19 in India were reported on 30 January 2020 in three towns of Kerala, among three Indian medical students who had returned from Wuhan, the epicenter of the pandemic. [10] [11] [12] Lockdowns were announced in Kerala on 23 March, and in the rest of the country on 25 March. Infection rates started to drop in September. [13]
Enrolling people with COVID-19 infection is simplified by gathering informed consent, and capturing data on an online clinical trial platform (Castor EDC). [ 6 ] [ 2 ] After the trial staff determine the drugs available at the hospital, the platform randomizes the hospitalized subject to one of the trial drugs or to the hospital standard of ...
The CTRI requests all the information which the World Health Organization recommends for clinical trial registries. [8] Additionally, the CTRI collects information specific to the circumstances of India, including the address of the principal investigator, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the Drugs ...
Trials indicate many vaccines developed for the initial strain have lower efficacy for some variants against symptomatic COVID-19. [454] As of February 2021 [update] , the US Food and Drug Administration believed that all FDA authorized vaccines remained effective in protecting against circulating strains of SARS-CoV-2.
In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years. [48] The trials are conducted at AIIMS Delhi and Patna. [49] As many as 54 children had registered at the AIIMS Patna. [50] In total 525 participants are enrolled in the study as per clinical trial data. [51]