A leading Korean contract research organization (CRO) called LSK Global Pharma Services will conduct the Phase 3 clinical trial of Sinovac’s COVID-19 vaccine candidate in Bangladesh. Targeting approximately 4,200 frontline health workers at seven Dhaka-based hospitals, this important vaccine trial centers on the nation in Asia with the second-highest number of COVID-19 cases—as of this writing it’s 317,528.
Just a week ago, Bangladesh authorities approved the late-stage clinical trial sponsored by China’s Sinovac Biotech Ltd in a bid to be at the top of the list for the vaccine, reported Reuters. Already state medical research authorities had signed off a month previous. Bangladesh has been considering Indian vaccines as well due to the severity of the epidemic.
Heavily Population Centers
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).
Busy Trial Sites
The hospitals selected as trial sites in the nation’s most populated city, Dhak (21m inhabitants), are treating large numbers of COVID-19 patients. This leads unfortunately to higher rates of health worker exposure (and infection) to SARS-CoV-2. Hence the use of the experimental vaccine in a bid to reduce the exposure and secondary infection.
Remote Clinical Trial
Due to ongoing COVID-19 infection concerns, the Korean CRO will manage the entire Bangladesh study remotely. While some in-person activities are a must—such as pre-tests, informed consent and actual administration of the vaccine, a number of other touch points can be managed remotely via tools such as ePRO, where patients can self-report on conditions. All data associated with the study will be transferred directly to LSK Global PS’s database with remote monitoring via an “e-source data management tool.” Consequently, investigators won’t have to visit the site when other tools can help do the job.
LSK Global PS and the company believe that the study can be done with higher quality patient-centered care in addition to a reduction in study cost and time.
LSK Global PS
LSK Global PS was founded back in March 2000. They are now a global, one-stop, full-service CRO encompassing all of the major areas of clinical research. By the end of 2019, the company had conducted 1153 clinical studies, including about 646 registered and about 134 global clinical studies. The company would be considered a mid-sized CRO with between 250 and 500 employees. They have secured accreditation Medidata (Dassault) electronic data capture and related “eClinical” products.