中美就加速癌症药物试验的协议展开讨论
Russell Flannery, Forbes.com, 17 December 2022
Health experts from the United States and China recently engaged in discussions regarding a potential collaboration to accelerate the fight against cancer by participating in multi-regional clinical trials. Following a summit between U.S. President Joe Biden and China President Xi Jinping in Indonesia, potential areas of improvement in the strained relationship between the two countries were identified, with a focus on cancer research and treatment. Jingquan Bi, a key figure in China’s health and drug regulatory sector, expressed optimism about overcoming obstacles related to a confidentiality agreement to allow China’s participation in Project Orbis, an initiative aimed at expediting cancer drug approvals through simultaneous regulatory reviews.
Project Orbis, led by the U.S. FDA Oncology Center of Excellence, involves several countries collaborating to review clinical trial data concurrently, thus reducing the time required for cancer patients to access new drugs and treatments. While eight countries are currently part of Project Orbis, China is not included. Dr. Richard Pazdur, the head of
U.S. FDA’s Oncology Center, highlighted the necessity for pharmaceutical companies to make simultaneous submissions to expedite approvals where significant delays exist. The success of Project Orbis has been evident in facilitating communication among regulatory agencies and establishing uniform standards globally.
Efforts to involve China in Project Orbis may involve addressing complexities in confidentiality agreements and exploring new initiatives such as “Project Pragmatica” aimed at simplifying clinical trials. The collaboration in cancer research between the U.S. and China is seen as a pivotal opportunity to revitalize their relationship, particularly in the context of addressing the significant cancer burden in both countries. Prominent figures such as Kevin Rudd emphasized the importance of successful collaboration in cancer research as a means to inject positive momentum into U.S.-China relations, with potential benefits extending beyond healthcare to broader bilateral dynamics.
