“Collaboration in the fight against cancer represents an important opening for the U.S. 2 in the number of cancer patients and overall cancer burden. More than 10 million people die annually from cancer China and the U.S. Other event speakers lauded the effort to get China involved. “We would welcome China to participate in Project Pragmatica.” “China (has) already participated in multi-regional global trials so their participation in Project Pragmatica would entail the agreement of the pharmaceutical sponsor,” Pazdur wrote. “There's really a need sometimes to simplify clinical trials to attempt to use clinical trials which replicate what's going on in the real world,” Pazdur said. “One of the problems that I've noticed as far as being an oncologist for almost 40 years now is that our clinical trials have become increasingly and increasingly more complex,” Pazdur said. One additional initiative to Project Orbis which could allow for China’s participation with other nations in the cancer fight could be a new effort launched by Pazdur’s center this year, “Project Pragmatica,” which aims to simplify clinical trials. “A limited confidential agreement between our two countries on a specific application might be a way to jump-start China’s involvement,” he said in a follow-on email to Forbes. Since there are multiple counties involved with Project Orbis this may be a long-term goal.” “I would be happy to further discuss participation of China in Project Orbis.” However, he continued, “the sticking point is the confidential agreement that would need to be signed. The complexity of confidentiality agreement approvals may yet need more time to work out between China and the Project Orbis members. So this does pose some problems of bringing in new countries to the Project Orbis,” he said, without mentioning China. All the partners have to have confidentiality requirements with all of the partners. “We welcome new partners,” Pazdur said, “However, we do have limitations, and some of these are just financial and logistic applications. “The success of this program really is unparalleled as far as fostering communication between the regulatory agencies obtaining uniform, regulatory standards,” he said. “So we asked the pharmaceutical companies to have simultaneous submissions to countries that had this delay, and then we would work with these countries to review these applications in a relatively expeditious fashion.”Īs of the end of 2021, the Project Orbis network had been part of 75 FDA drug applications tied to cancer care 35% were aimed at new types of cancer-related molecules, and a total of 250 applications had been submitted globally across the eight partner countries, said Pazdur, who oversees Project Orbis in his capacity as director of the Oncology Center of Excellence at the FDA in Washington D.C. “Many times this delay was in the matter of months, but many times it was years that patients were delayed getting important cancer drugs,” he said. Richard Pazdur told the meeting organized by New York-headquartered Memorial Sloan Kettering Cancer Center, or MSK, and Guangzhou-based Chinese Thoracic Oncology Group, or CTONG, that member nations in Project Orbis sought progress by “asking pharmaceutical industries to do simultaneous submissions to countries where there was a significant delay” in new drug approvals. Bi made a mark there by regulatory reform on clinical trials data transparency and in 2017 led the Chinese agency to join the International Council for Harmonization, ushering a new regulatory environment in China adopting global standards. His former agency - the China Food and Drug Administration – has been restructured as the National Medical Products Administration.
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