Weak clinical trial transparency in China: A global issue

Companies running drug and vaccine trials in China are under no legal obligation to make study results public, a new regulatory analysis supported by TranspariMED shows.

Chinese trial regulation has global health implications, the study notes:

“China conducts one of the highest numbers of clinical trials globally and is now a major exporter of medical products... A 2019 study found that ChiCTR ranked third among all ICTRP-linked registries in terms of the number of registered trials, with over 24,000 studies registered.”

“As of May 2022, China had exported nearly two billion doses of COVID-19 vaccines, accounting for 32.2% of the world's share of exports and ranking second among all producing economies, ranking behind the European Union but ahead of the U.S.”

One country, two platforms

Currently, clinical trial registration and summary results reporting on registries in China are achieved through two platforms:

• ChiCTR

• ChinaDrugTrials.org.cn

The nonprofit ChiCTR registry forms part of the global network of clinical trial registries run by the World Health Organisation. Under Chinese law, neither registration of trials nor reporting of their results on ChiCTR is mandatory. While ChiCTR’s terms of use state that trial results should be made public on the registry within one year, this is not legally enforceable.

The ChinaDrugTrials.org.cn platform is managed by the Chinese drug regulator. For many types of trials, registration on the platform is mandatory. Those registrations are then made public in a format that broadly reflects that used by WHO trial registries. Sponsors are required by law to upload the results of trials within a year of trial completion, but those results are exclusively visible to the regulator and are not made public.

The opacity of the Chinese regulatory system makes it impossible to determine the extent to which companies comply with results reporting requirements on ChinaDrugTrials.org.cn, and makes it impossible to assess whether the Chinese drug regulator is enforcing the law in practice. On the positive side, Chinese disclosure laws cover a far broader range of trials than comparable United States legislation (FDAAA Section 801) does.

The authors conclude that:

“Our study shows that neither [China nor the U.S.] effectively ensures that all clinical trial results are made public as required by the Declaration of Helsinki and recommended by the WHO.”

“The U.S. framework is significantly more transparent in that summary results uploaded to ClinicalTrials.gov become publicly visible, while results uploaded to ChinaDrugTrials.org.cn remain hidden from public view. At the same time, Chinese disclosure laws cover a far broader range of studies. While the U.S. seems to have a lead in terms of transparency, neither country is perfect, and both may be able to learn from each other.”

“Comparing the actual extent of non-publication across both jurisdictions was beyond the scope of our study. This is a major gap in the literature that we hope other researchers will address in future."

"More broadly, we encourage fellow regulatory scientists to take a global perspective and routinely include China, India, Japan, Iran and other non-Western hubs of medical innovation in future comparative legal and regulatory analyses.”

The study was led by TranspariMED intern Yixuan Chen and has been published as a preprint.

The lead author is currently submitting the study to a peer-reviewed journal. If you know experts in Chinese trial regulation who might want to act as peer reviewers, please contact TranspariMED.