George Clinical (GC) is collaborating with a global, research-based biopharmaceutical company to evaluate the effect of a new chemical entity in subjects with type 2 diabetes and nephropathy.
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GC is responsible for project management (PM) and monitoring throughout the Asia-Pacific. Other regions were managed by a separate contract research organization (CRO). Globally, there were 841 activated sites. In the Asia-Pacific, GC was responsible for managing a total of 137 sites. The countries included: Australia; China; Hong Kong; Korea; Malaysia; New Zealand; Taiwan and Singapore. Globally, GC led the endpoint adjudication (EPA) services.
Where the GC EPA team provided end-to-end services for endpoint identification, collection, adjudication and reporting, they ensure the EPA process design and efficacy.
The study experienced recruitment worldwide delays. The complex screening requirements determined screening activities as the project team’s main metric. The number of screen patients in early 2016 was behind by approximately 20%, with a screen failure rate of 53%.
One of the uniquely effective strategies implemented by GC to overcome the recruitment challenges was leveraging the scientific leadership. The scientific leaders (SL) in this study are widely recognised leaders in their field. As such they were able to leverage their strong relationships with participating national leaders and principal investigators.
Typically, many investigators are reluctant to screen ‘borderline’ patients so that their screen failure rate would not be affected. For this study, however, sites were encouraged to take all screening opportunities available as the throughput to randomization was expected to be low. Investigators were also reluctant recruiting patients to the study due to its complexity.
GC’s SLs are regional leaders accustomed to local practices and culture. As such their ability to
engage with regional investigators and convince them of the ethical and scientific benefits of the study was considerably enhanced.
As a result of GC’s scientific engagement, 37% of GC managed sites were actively screening patients throughout the study, compared to 27% in the United States and 26% in Europe. GC managed sites obtained superior recruitment performance when compared to other sites.
About George Clinical
George Clinical is a leading clinical research organisation in the Asia-Pacific region with over 260 staff operating in 11 countries. George Clinical provides a full range of trial management services to pharmaceutical and biotech customers, for both registration and post marketing trials. Our parent organization, The George Institute, is a leader in chronic disease research with a global network of experts. George Clinical combines this scientific and clinical leadership from the Institute with world class trial delivery capability to create a distinctive service. Our internationally recognized scientific leadership allows George Clinical to provide excellence from design to delivery. Gain access to Asia.