Duke Forging Research Ties in China
For nearly a decade, the Duke Comprehensive Cancer Center has been exploring the world's most populous country, talking to Chinese leaders and researchers, "looking for ways to collaborate on our common goal - eradicating cancer," said Dr. H. Kim Lyerly, center director. In 2007, Duke entered into a formal partnership with the Peking University Health Science Center, which includes a hospital focused exclusively on cancer larger than most general hospitals in America, with 800 beds and treating more than 150,000 patients a year.
Yet how many of these Chinese receive the chemotherapy and biological agents that have been approved by the U.S. Food and Drug Administration? "In a timely manner? Not very many," said Dr. Wei Chen, a cancer researcher on the faculty at Duke who was born in China.
China has its own regulatory body, the State Food and Drug Administration. For various reasons, neither country has accepted the results of most research done by its counterpart. Dr. Chen hopes that the Duke/Peking University partnership will begin a process that might eventually break down that wall.
The partners think they can provide the government agencies in both countries with a groundbreaking example of collaborative research that will meet the standards and expectations of each. "We plan to identify some pressing and pertinent problems," said Dr. Chen, "and attack them synergistically, taking advantage of the strengths and assets of each institution's medical system."
One of the first initiatives will probably be a breast cancer treatment trial, sponsored by Duke, with Peking University Health Science Center serving as a remote site. Drs. Lyerly and Chen visited Beijing last September, along with Dr. Ken Buetow, director of the NCI Center for Bioinformatics, to begin preparations for caBIG.
NCI's Cancer Biomedical Informatics Grid (caBIG) provides the electronic environment and platforms to connect cancer researchers so they can communicate data and work seamlessly. This project will be caBIG's first overseas application.
Merging electrons is one thing, but "it's far more challenging to bring the medical cultures and practices of two major medical systems into synch," said Dr. Chen. This month, six clinical researchers from the Peking Cancer Hospital are at the Duke Medical Center, getting formal training in the procedures and protocols expected by the FDA for the conduct of clinical trials.
The Chinese clinicians will return to China with the know-how to run the trial, but "modifying the culture of current Chinese medicine that is practiced at even advanced medical centers will require a lot of persuasion and dialogue," noted Dr. Chen. As the trial nears, researchers from Duke will travel to China to provide advice and convey the rationale at the crux of the partnership.
An enormous evidence-based literature has accumulated in the West, explained Dr. Chen, "but as scientists we really can't say whether these data apply to the Chinese," given differences of race, environment, and different therapies. Tissue banking, pharmacogenomics, and clinical trials like this one will begin to establish the foundation for truly consensual data that the partners hope can bring regulators and governments in both countries together.
Even though breast cancer incidence is lower in Asia than in the West, with a population of 1.3 billion, China has more patients than the U.S. or any other country. Among people over the age of 65, "cancer is their number one killer," explained Dr. Lyerly, and "with 110 million people older than 65, [that is] twice the number here. Breast cancer is a huge problem," and is growing as much as 3 percent each year.
"The opportunities are tremendous from this large pool of patients," said Dr. Lyerly. "As we increasingly consider providing and testing treatments for certain types of cancer based on a specific marker or genetic fingerprint, we will need to be able to rapidly access large populations of cancer patients with those characteristics." So the benefits clearly run in both directions. "It's a win-win," he explained, "and serves to illustrate the opportunities for the sorts of collaborations we think will be crucial to address the looming issues of global health care in the 21st century."