Craig Davenport, senior director, China clinical drug development, Eli Lilly and Company, Lilly China, said the partnerships is a “natural fit,” given Lilly’s increasing presence in China coupled with Parexel’s training program via the Parexel Academy.
“The goal is to develop more and more highly capable clinical researchers in China,” Davenport told Outsourcing-Pharma.
“The need for this is attributed to the changing drug registration regulations in China that are allowing new sites to participate in clinical research due to the government discontinuing of its clinical research site accreditation program,” he added.
Dr. Albert Siu, corporate vice president, global learning and development for Parexel, said the companies’ combined efforts will help investigators gain practical experience in conducting clinical trials that meet local and global regulatory and audit standards.
“Investigators are the core factor that determines the quality of clinical trials, but currently China is experiencing a major shortage in clinical trial investigators, creating a huge demand in research training and development,” Siu told us. “The severe lack of investigators could result in the slow-down of drug innovation in China.”
This is the first time Parexel is offering the program to the China market, though Siu said the company studied the demands and expectations of Chinese investigators to design the Investigator Joint Certificate Program.
However, capacity and time restraints among hospital and clinical research staff could prove a challenge. “Clinical research in most institutions continues to be work in addition to typical duties of clinical staff,” said Davenport, adding that prioritization of clinical research by institutions “will be ever more important as the environment becomes more conducive to bring new drugs to market.”
In response to these market changes, Parexel last month launched an advisory service dedicated to helping clients navigate the growing opportunities in China.
“Further reforms in the clinical drug development environment are making it increasingly possible and desirable for multinational pharmaceutical companies to engage China in global, simultaneous drug development,” said Davenport.
“Combined, these factors dramatically increase the need for more and more clinical research sites. Ultimately this will enable earlier availability of innovative drugs to patients in China,” he said.