Global Trials In China Rich But Challenging – Wyeth Exec

TOKYO - Clinical trials in China have much potential and can be rewarding if pharmaceutical companies are willing to overcome challenges such as working with young researchers in China, who may not have much pharmaceutical experience, said Ling Su, Wyeth vice president of clinical research and development for Asia Pacific.

Based in Shanghai, the Wyeth exec was one of the keynote speakers at a Drug Information Association conference in Tokyo on May 29.

"We not only need to recognize the challenges [for clinical trials in China], but probably more importantly we need to recognize the actions that are happening and also the proposals that we can develop to meet the challenges and move forward," he said.

Regulatory challenges in China, including lengthy clinical trial authorizations, can be difficult to manage, he says. There is no comprehensive data and analysis on review and approval times, although China's State FDA Center for Drug Evaluation data indicate 67 percent of clinical trial application reviews are completed within seven months.

Regulation in China can be complex because there is an old system that deals with the "massive, domestic de facto generics, and an evolving [system] that deals with innovative products mainly from multinationals," he said.

SFDA's Center of Drug Evaluation is staffed with 120 people, including 100 reviewers. They are broken into two groups: one reviews traditional Chinese medicine and the other reviews all other drugs. "We are talking about 60-some people working on Western drugs and biologics - a tiny, tiny number of reviewers reviewing thousands of patients," he said.

Even with limited resources, there is still much the Chinese regulatory agency can do to expedite the process, he said. For example, China can use a greater number of "prior" reviews and/or "prior" reviews by other competent agencies, he said.

Cutting Through The Red Tape

Sponsors can make the review process go smoother by ensuring that dossiers are up to standard since poor data quality has been cited as a reason for prolonged reviews, he said.

Local regulatory affairs staff can also do a better job communicating with agency reviewers by being able to clearly address issues on their own instead of being simply messengers for the company, as was the case in the past (Also see "Focus On Clinical Trial Review Process In China Before Timeline Reform – Merck Exec" - Scrip, 4 Jun, 2008.).

For example, being able to explain the uniqueness of a particular study will help both companies and reviewers in complicated oncology studies.

Also, many Chinese reviewers are young and eager to learn, so if a sponsor is proactive, innovative and adaptive, it will help both parties in the long run, he says.

Location, Location, Location

The choice for a clinical site will also be key for a company's success in working in China, he said, pointing to the argument that the limited number of clinical sites within China hinders its ability to conduct more trials.

In 2004, SFDA and the Ministry of Health started a system to accredit clinical trial sites. As of 2007, out of about 19,847 hospitals in China, only 1,182 were deemed tertiary hospitals. In that pool, as of 2008 only 186 hospitals have been accredited as clinical trials sites by SFDA. Some 33 hospitals of the accredited pool are dedicated to traditional Chinese medicine, so only 153 sites are available to do small molecule, biologics and Western device studies.

Accreditation in China is specific to a specialty and within one hospital multiple specialties can be accredited. As a result, these 153 hospitals cover more than 1,100 specialty sites. At the moment, SFDA is assessing 100 additional hospitals for accreditation to meet growing demand, he said.

"The government continues to accredit more sites and that will take some time," he said. "On the other hand, there are many 'under-utilized' clinical sites."

Companies shy away from such sites because they may lack experience in global trials or may seem too remote when compared to hospitals in key geographical cities like Shanghai, Beijing or Guangzhou.

He advised companies that it is important to foster and optimize the potential of existing sites.

He shared Wyeth's experience with such a clinical trial site only 30 minutes away from Shanghai. The hospital was an under-utilized site with no experience in a global study. "We put in more effort and training and resources [to this site compared to other sites] … at the end of the day, this site became one of the best sites in my program and now I think they enjoy a lot of work from multinationals. You need to take a prudent risk," he said.

Coupled with the potential such Chinese clinical sites can offer, he says a "green but promising employment pool" exists in China with droves of new college graduates in chemistry and biology.

- Yuriko Nagano ([email protected])