GCP in China is coming along, but much more is needed.
Jean-Paul M.F. Deslypere, MD, PhD, and business development manager, life sciences-Asia Pacific SGS Life Services, Singapore, said to a well-attended DIA session on this topic: “Without proper training, clinical trials in Asia could result in a disaster waiting to happen.”
As another introduction to training investigators in Asia, Deslypere, session chairperson, said that industry is made of believers and non-believers on conducting trials in Asia, which has grown in the past 10 years, and most significantly in the past three and four years.
Sandra Garrett, PhD, and executive chairman of Global Research Services, presented on trial conduct in China. Having been providing services to pharma clients for the past 10 years, her insights into the current landscape were practical and realistic. She asked the attendees how many were conducting trials currently in China, with about three raising their hand. She then asked who was planning a trial in China within the next year, and that number went up to about 10. Her advice: “Don’t go in thinking that it’s clinical research and we can do this anywhere. You need a paradigm shift in thinking when dealing with China.”
Why? Well the numerous challenges to conduct in China, including: no data standardization, concerns regarding stands and patient informed consent, practice, cultural and language barriers, SFDA (State FDA, the Chinese equivalent to FDA) with minimal experience overseeing large-scale clinical trials, considerable variations in local government requirements, and a lack of standardized experience among IRBs and undefined Adverse Events Reporting systems.
Garrett stressed the need for training that meets the requirements of you who is being trained and why (i.e., delivering service in a hospital setting is different than delivering service in clinical research). She also highly recommends that expert staff be utilized for training, that it be bilingual (Mandarin and English) and highly, verbally interactive. For example, she said that training using Twitter, Skype, video, email…any ability that allows student and instructor to interact verbally is highly valuable.
Jenny Zang, MD, MHA, business development director for Chinese CRO Tigermed Consulting, and president of the China Chapter of ACRP, also offered insight into the current training issues and abilities in China today.
Specifically, she noted that the SFDA initiated a mandatory certification of sites that conduct clinical trials in February 2004. Sites can include hospitals, institutions, PI units, and therapeutic departments. As of March 2009, 325 sites have received that certification.
Zang also offered updates on the ACRP China Chapter training and attendee numbers for 2008-2009. In its Beijing/Shanghai programs, 214 attended. In the Shanghai Clinical Research Center, with which ACRP has partnered to offer training and certification throughout the country, it featured 694 attendees within the same time period.
The major challenge to clinical trials in China is the shortage of trained staff.
Kiran Vithaldas Marthak, MD and director of Veeda Clinical Research in India, addressed clinical trial training mainly in that Asian country, and mentioned that from January to June of this year, 240 protocols had been approved in India. He also updated the audience of a June 15, 2009 enactment that requires all trials that are conducted in India must be registered.
Marthak also outlined the great jumps of the number of registered FDA investigators in all the Asian nations in the past 10 years. India leads with 622, followed by Japan at 286, South Korea with 165, and China with 134.
In the end, there are many training initiatives, which vary by each Asian country. One attendee asked what was thought of the move toward certification as a way to address these training and GCP issues. Marthak thought within two years, certification would take hold.
However, Garrett cautioned that certification was putting the carriage before the horse. “We haven’t seen the tip of the iceberg for standardized training in India and the rest of Asia. Only 200 trained in ACRP last year in China, but we need 20,000 to handle the trials that will be coming in from the West,” she emphasized. Garrett also believes the onus is on the pharma company conducting its trials in China to bring the training to investigators.