Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Kent Thoelke, Executive Vice President, Scientific & Medical Affairs for PRA, spoke at the Partnerships conference regarding trial conduct differences in China, featuring what seemed to be very practical, hands-on advice.
For example, in China on the patient or participant side, family engagement throughout the clinical trial is also key. In China, patients keep and carry their health records. While the country is investing in EMRs, right now it’s still a very basic process.
Also, in China, traditional medicine is still used primarily by the Chinese for a number of reasons and conditions. These concomitant medicines can play a role in drug metabolism, so it is important to verify with the patients what they are taking.
In addition, Thoelke noted there is a difference of treatment between socio-economic classes. Specifically, the standard of care vs. the “usual care.”
On the business side, most global CROs have a relationship with a local CRO, which Thoelke stresses is important to navigating the cultural and regulatory norms. And he stressed that relationships are key in China. The investigator community is very networked, which he acknowledged can make negotiations and contracts difficult because the investigators know and share that information.
He also said, because of these relationships, the way to do site feasibility is to go to the site. “You can’t do feasibility like anywhere else in the world,” Thoelke noted. “You have to go there.”
Following Thoelke’s presentation was R. Stephen Porter, PharmD, FCP, with VDDI Pharmaceuticals. Porter spoke frankly to other issues in China, which can be related to fraud or corruption. He noted that there is a clamp down on corruption in China, and he specifically referred to the execution of the former SFDA’s chief for corruption in 2007. Another difference at the SFDA, besides having 200 reviewers vs. 2,034 at the US FDA, is that a reviewer is held responsible for an approval for the rest of their life. So the wiggle room for scientific developments or safety issues in larger populations is not the same as here.
However, outside of that, other issues that come into play include that 51% of hospital revenues in China come from pharmaceutical prescriptions. This practice has led to what Porter calls unintended consequences, specifically in the over-dispensation of antibiotics leading to a very high rate of MRSA and c. Difficile.
Another unintended consequence may be the underreporting of adverse events. Culturally, Chinese people won’t complain about a doctor’s care, and that they may be embarrassed to report an adverse event. Also, culturally, Porter said that there is a huge patient blogsphere in China, and other communications include texting and social media platforms such as WeChat.
And to put in perspective what China looks like today, there are 530 approved clinical trial centers in the country compared to 55,000 in the United States. China is rapidly approving these centers, but that is the status now.