US scrutiny may challenge China’s clinical-trial advantage, analysts say
Analysts warn that growing scrutiny in the United States of early clinical trials conducted in China could threaten an advantage that has helped the country’s biotechnology sector expand. US lawmakers and FDA officials have questioned transparency and reliance by American drugmakers. The supplied material gives no proposed policy or timeline.
China’s ability to conduct early-stage clinical trials quickly and at relatively low cost has helped strengthen its position in the global biotechnology industry, according to analysts cited by the South China Morning Post. That advantage could face pressure from the United States. American lawmakers and officials at the Food and Drug Administration have raised concerns about US pharmaceutical companies’ increasing reliance on early trials in China.
The concerns include what officials describe as a lack of transparency in the process and questions about the need to protect medical information. The supplied material does not detail particular trials, companies or drugs at issue. Analysts warn that steps by the United States to restrict or otherwise curb this reliance could affect China’s role in early clinical research.
However, the available report does not identify a specific proposal, rule or timetable from US lawmakers or the FDA. South China Morning Post’s account does not quantify China’s market advantage or say how biotechnology companies have responded. It reports the analysts’ assessment and the concerns raised by US officials without establishing that any policy change has been adopted.
This independently written report is based on information supplied by the named publisher. Vertrix News has not independently verified the source report.