The privately-owned contract research organisation (CRO) opened the new office in Beijing last week – its second in China after the unit it set up in Shanghai in 2005 – citing the industry mantra of growing pharma demand and improved access to patients as the motivation.
But Outsourcing-pharma.com wanted to know more. We asked PRA executive VP of scientific and medical affairs Kent Thoelke about the investment who told us that the lack of competition and China’s demographics make the country attractive for trials.
“The number of competing trials in China today is limited, while access to potential patients and trial sites is significant, leading to the ability to increase trial recruitment rates and decrease overall clinical trial timelines.
“Demographics such as the aging population, chronic disease growth, expanding healthcare insurance coverage, urbanization and increased investment in rural healthcare help expand clinical trial access.”
Thoelke also said that sponsors attracted by the Chinese pharmaceutical market – currently valued at $40bn (€31.8bn) and expected to be worth $100bn by 2015 – will need to conduct more and more research in the country.
“In order for pharma and biotech companies to ultimately market their drugs in China, they are required to run trials within China, thereby expanding the need and demand for clinical trials. As a result, there is a need to run trials across all phases within China, and PRA is conducting trials in all of these areas.”
Regulations
Thoelke went on to say that in most respects the business of conducting clinical trials in China is no different from any of the other 80 countries in which PRA operates.
“The sites that participate in trials in China are all high-quality, ICH/GCP-trained sites that have been approved by the Chinese SFDA. Physicians and investigators within China who participate in these trials are leaders in their field and critical contributors to global trials.
"Additionally, thanks to the country’s centralized healthcare delivery and socialized medicine, its hospitals have some of the largest patient populations in the world. Its healthcare system allows for an extremely efficient patient recruitment and access process.”
But while there are similarities, there are also differences he continued, citing China’s strict regulatory criteria as having the most significant impact on how PRA conducts research in the country.
“The biggest difference in conducting trials in China as opposed to other countries is the longer regulatory start-up timelines. The lead time to get clinical trials approved in China can range from 9-18 months, requiring greater upfront planning for the inclusion of Chinese sites in a global clinical trial.”
Thoelke added that – with this in mind- PRA opted to set up its new Beijing office near the Chinese Food and Drug Administration (SFDA) HQ, which he claimed helps the firm minimise timelines.
He also suggested the firm will be adding extra staff in China, commenting that: “While our Beijing office is now fully staffed, PRA will continue to hire employees proactively across China, as needed.”