Tuesday, 27 November 2012

Lancet profile of Dr Lixin Jiang: at the heart of China's evidence base

Dr Jiang Lixing
by David Holmes
There's a quiet revolution going on in China, and Lixin Jiang is at the very heart of it. 
Since the turn of the millennium, Jiang has been in the vanguard of a growing movement within the Chinese medical profession to make evidence-based medicine the foundation of their practice, and to build the evidence base from within China itself. And with the support of Shengshou Hu, the influential head of Fuwai Hospital in Beijing, where Jiang is based at the affiliated National Centre for Cardiovascular Disease, she has been a “whirlwind force for evidence” says Richard Peto, Co-Director of Oxford University's Clinical Trial Service Unit (CTSU).
Since 1999, Jiang has worked closely with Peto and his fellow CTSU Co-Director Rory Collins on a succession of large, international trials, and she credits the pair with opening an “entirely new window, through which I not only learned how to manage large-scale clinical trials in China, but more importantly, learned how to look at the world with critical eyes”. This though, according to Peto, is Jiang being too modest. “She was really excited by the idea of clinical trials and we just introduced her to the concept. She picked up the ideas and ran with actually making them work, and trying to actually get them accepted within the Chinese medical profession.”
Jiang's first large-scale trial, COMMIT, was a baptism of fire, with over 45 000 patients with acute myocardial infarction enrolled from 1250 hospitals. With guidance from CTSU, Jiang began to oversee the routine running of the trial in China in 1999, and during the next few years she took her team to monitor more than 400 hospitals throughout China, including many smaller, secondary hospitals in remote rural areas. As well as providing a crash course in the vagaries of clinical trial management, the study affected Jiang on a personal level. “I was born in the city and I didn't have a real picture of rural life; before that study I lived in a very limited, narrow world”, she says. “But when I visited these hospitals I was so touched by the real situation; so much poverty, it was so difficult for doctors and patients in rural areas at that time. And through visiting these kinds of hospitals all around China, it touched me so deeply, and I learned about China, I learned more about hospitals, and I learned about clinical trials.”
COMMIT was a watershed moment not just for Jiang, but for clinical research as a whole in China. “The Chinese doctors were really excited to have good evidence, Chinese evidence, about the treatment of Chinese patients in Chinese hospitals”, says Peto. After visiting a number of trial sites, the US Food and Drug Administration approved a new indication for clopidogrel in acute myocardial infarction: the first time such a decision had been based on data solely from China. The “research got taken worldwide and influenced worldwide treatment patterns”, says Peto. “Without her it wouldn't have succeeded”. An auspicious precedent thus set, Jiang has gone on to coordinate a succession of large, long-term, international clinical trials and case-control studies in China, including HPS2-THRIVE, TRACER, and HPS3/TIMI55:REVEAL, INTER-HEART, and SHARP.
The success of these studies owes a huge debt to Jiang and her team's meticulous planning and tireless capacity building, according to Runlin Gao, Chief Cardiologist of Fuwai Hospital and the immediate Past President of the Chinese Society of Cardiology. “She established a committed research team and a stable collaborative network, including nearly 200 large hospitals in China, and she and her team also developed some practical modules for running trials in China, such as the pre-registration of potential participants, a process of identifying capable and committed local sites, and central monitoring”, Gao explains.
But for all the progress that has been made, Jiang is a realist. “Sometimes I say that maybe our limitations are much bigger than our strengths”, she comments, pointing to the complexity of the regulatory system in China. The process to get a trial approved “generally takes about 10 months to 1 year”, explains Jiang; “that is longer than most other western countries, and the process is not very easy”. The unfamiliarity of patients with large-scale clinical research in China can also present problems. “Patients do not fully understand this type of study, they very often have doubts about our motivation, and we don't have a very harmonious relationship between doctors and patients here, and that is a very big problem”, says Jiang.
“Overall”, Jiang says, “the government has greatly improved the conditions for clinical research, but we still have a long march to go. We in China really need evidence not only for clinicians but also for policy making, so China should accelerate the pace of improvement.” As Principal Investigator of China-PEACE, a major cardiovascular outcomes study funded by the Chinese Government that involves more than 200 hospitals across China, Jiang will play a pivotal part in generating this knowledge “for China from within China”, says Gao. And as Honorary Editor of The Lancet Chinese Edition, Jiang says she hopes to “accelerate the dissemination of knowledge, and the concept of evidence-based medicine” in China. According to Peto, she will succeed. “She's making things happen that I don't think anyone else would be able to make happen”, he says. “She's really the trialist to watch.”
Read more: The Lancet

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