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First patient screening in seven months avoided lapse in Chinese regulatory approval.

SITUATION

A pharmaceutical sponsor with a US Phase III metastatic pancreatic cancer study had previously applied for Chinese regulatory approval (NMPA). However, due to the impact of COVID-19 and other administrative reasons, no site identification or site activation work had been undertaken by the sponsor or their partners for more than two years. A deadline is set by NMPA that in order for the approval to remain, the first patient must be screened within three years of the issuance of the approval.

As the deadline approached for the approval to lapse, George Clinical was engaged to keep the trial application open by ensuring that the first patient within China, would be screened within seven months.

The loss of trial application would have cost the sponsor financially and would also have deprived the more than 200 Chinese patients (more than 400 globally) the opportunity to participate in this important study. Pancreatic cancer is a devastating prognosis with the lowest survival rate of any group of cancers and limited treatment options. Clinical research in this area is imperative, and The Pancreatic Cancer Action Network strongly recommends clinical trials are considered at diagnosis and during every treatment decision for these underserved patients.

CHALLENGES

George Clinical had less than seven months to get the first patient screened to avoid trial approval lapse in China, and the sponsor had no experience working in China. We were also contracted to open 60—70 sites in China. In order to choose sites most likely to meet this incredible timeline, a small cohort of fast acting sites had to be identified and activated. In addition, because there had been no work done for such a long period of time, there were massive amounts of complex documentation and authorizations to manage, relating to both regulatory and the study—many needing significant translation.

Ultimately, George Clinical had less than one week after receiving full regulatory approval to do a site initiation with 30 people and literally screen the first patient.

SOLUTIONS

George Clinical is no stranger to tight timelines and crucial deliverables where collaborative teamwork, dedication and flexibility are needed to succeed. These are hallmark traits of our people around the world, and our team in China worked tirelessly to meet every challenge—solve every problem. Under the leadership of Global Project Management in the UK and Regional Chinese Operations Management, the study team was motivated and empowered to achieve the goals for the sponsor and the potential patients.