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Innovative Drugs Summit Forum: China to Catch up with Early Clinical Trials
2017-04-29Return>>

Multinational pharmaceutical companies in China, like a planter, brought the concept of clinical trial to China starting from scratch. The driving force of increased capacity, for the future of China's clinical trials, is derived from the continuous innovations from the local companies.

"The design of clinical trials for innovative drugs at initial stage is crucial, and it requires a high level of knowledge and experience. It is a quite demanding and complex project and necessitates a close cooperation among specialists from a wide range of fields " Dr. Tan Lingshi, who is now the Founder and CEO of dMed Biopharmaceuticals Co., Ltd., indicated in a report that Pfizer has witnessed a few large international and multicenter clinical trials getting into in China. Such talents in the pharmaceutical companies and other participant parties are seriously lacking, and the resulting risks are immeasurable, especially in early clinical trials. With the increasing number of Chinese innovative drugs entering clinical trials, Dr. Tan Lingshi said that the risk in clinical trials would be greater. He recently discussed with some of the colleagues based in multinational corporate headquarters who are responsible for clinical trials. Some companies projected to cover 30% of the company's global clinical trials to adopt risk-based monitoring (RBM), while some even planned to cover 100% of the projects to comply with RBM requirements.



He informed the representatives of domestic participants that risk-based monitoring was a dynamic approach of thinking of the quality of the clinical trials, where monitoring resourcing was always focusing on the most critical aspects of the trials. RBM will start from the design of the protocol, but it will not have a termination. Identify risks - Manage risks - Identify new risks will be repeated continuously. RBM will always be the core in all clinical trials. Thus, all parties involved in clinical trials should take the initiative to intervene and take the initiative to engage in risk management.

Dr. Tan Lingshi mentioned that the multinational companies are likely to enter directly into China, overlooking the local companies, to invest in the establishment of early clinical research centers after China develops the policy of concurrent drug development across the globe. "Pfizer has established three First-In-Human clinical research centers around the world." He put up three fingers, one in Belgium, one in Singapore, and another one in New Haven.

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