SEOUL -- LSK Global Pharma Services, a leading contract research organization (CRO) in South Korea, will carry out a third-stage clinical study to test the efficacy of a COVID-19 vaccine candidate being developed by China's Sinovac Biotech, covering some 4,200 medical staff at seven hospitals in Dhaka, Bangladesh.
The Phase 3 clinical test of Sinovac's vaccine candidate, PiCoVac, is designed to reduce secondary infection at the hospitals that have focused on treating COVID-19 patients, leading to higher infection rates among doctors and nurses.
The examination of participants, informed consent and vaccine administration will be conducted face-to-face while future prior consent and health status reports will use online and ePRO solutions. An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. Clinical data can be entered directly into the database of LSK Global PS for monitoring remotely.
"It is meaningful that LSK Global PS will be in charge of large-scale global Phase III vaccine clinical trials at a time when COVID-19 gets prolonged, causing a number of confirmed cases and deaths worldwide," LSK Global PS president Young-Jack Lee said, adding his company has prepared non-face-to-face clinical trials for years.
Non-contact clinical trials have the advantage of being able to carry out patient-centered high-quality clinical trials at low cost and time, becoming a "new normal" in some countries. LSK Global PS is the first domestic CRO to introduce a system for remote clinical trials.
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