04 September 2020 | News
The company adopts non-contact clinical study in Bangladesh via remote monitoring of trial site using e-source data management tools
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Korea's LSK Global PS, a leading CRO to run Sinovac Phase III COVID-19 vaccine trial in Bangladesh.
The company would manage the trials remotely with non-contact interventions instead of taking the traditional site-centered approach, on the background of COVID-19 infection concerns. Clinical data will be sent directly to LSK Global PS's database and monitored remotely without investigators having to visit the site through the use of an e-source data management tool.
As per the company reports, the study involves procedures, including pre-tests, informed consent, and administration of the vaccine, are carried out face-to-face while online tools and an ePRO solution will be used for additional informed consent and reporting of the participants' health conditions. The non-contact clinical trials are expected to generate a high-quality patient-centered clinical trial can be conducted with reduced cost and time.
This clinical trial will involve about 4,200 frontline healthcare workers at seven hospitals in Dhaka, Bangladesh. According to the company, Bangladesh has the second-highest number of Covid-19 cases in Asia, with more than 300,000 confirmed cases so far.
Sinovac is signing up large, heavily populated nations for Phase 3 clinical trials as the number of coronavirus cases in China continues downward. Meanwhile, Sinovac signed up Indonesia (268m) and Brazil (210m) and, of course, now Bangladesh (161m).