Rutgers Researcher Seeks Credibility for Chinese Spine Trials
BY LAUREN UZDIENSKI, NOVEMBER 29, 2006
In 2005, Nature reported that companies were "queuing up" to conduct clinical trials in China, where a large population simplifies the enrollment process and research could be conducted at lower cost than in the U.S. Similar trends can be seen with pharma companies conducting trials in India. According to Nature, China has struggled to produce trials to Western standards, particularly in relation to GCP. Some clinicians running the studies lack familiarity with Western protocol, and patients have complained they weren't warned of risks or compensated as agreed. Others claimed to have signed consent forms they didn't understand or that doctors didn't explain.
Chinese trials, which began to grow in popularity following 1999 safety regulations, seem to be off to a shaky start in the eyes of the Western medical establishment. Yesterday the Wall Street Journal (subscription required) reported on foreigners coming to China to pursue risky, untested surgeries purported to correct spinal column damage. Many of these surgeries involve implanting cells from aborted fetuses into the spine. Wise Young, a Rutgers professor and a leading spine researcher, is planning to launch a major series of trials that will test the safety and efficacy of procedures like these, ideally lending credibility to the Chinese system of clinical trials. Dr. Young's plan will include four trials a year over a five-year period, and it is expected to cost less than $10 million.
China's patient pool, the result of more than 60,000 spinal cord injuries each year, is ideal for a large, randomized study. But the Journal outlines the challenges Dr. Young faces: the size of the study makes it hard to monitor, particularly considering Dr. Young's distance from the trial itself and any lack of familiarity the Chinese researchers may have with Western practices.
"We lose too many opportunities if we are conservative and play it safe all the time," the Journal quotes Dr. Young.
Hundreds of patients have already received the cell transplant procedures, some of which involved fetal stem cells. The use of these cells is rarely allowed in humans, and Dr. Young's work will provide a rare source of data. It's expected to be the first major trial to test the implantation of stem cells into spinal-cord patients.
Despite bureaucratic and ethical hurdles, Dr. Young's research has the potential to be groundbreaking for spine patients. If trials are executed properly, with adherence to GCP, China's cost benefits and large population seek to open doors to scientific progress.
