New study shows that China is now a global powerhouse of clinical research

China is now the world’s top venue for clinical trials. A new study based on data from multiple clinical trial registries shows that more than 11,000 interventional clinical trials were registered in China in 2023, around 50% more than in the United States.

Of course, a larger number of trials does not equal more gain in useful scientific knowledge. For example, the UK excelled at generating robust and useful evidence on potential Covid treatments precisely because it focused its efforts on a small number of large, well-designed trials.

Nonetheless, the new study makes clear that China is now a global powerhouse of clinical research.

Concerns about transparency 

This is concerning because there are some indications that clinical trial transparency in China may be substantially weaker than in Europe or the United States.

Recent studies led by a TranspariMED intern found that Chinese law does not require companies or universities to make clinical trial results public, and found indications of disclosure shortcomings at Chinese biopharmaceutical companies operating abroad.  

Similarly, the new study found that many clinical trials in China and other countries in East Asia are not being prospectively registered.

Data gaps on East Asian trials

The new study’s authors also tried to assess how many clinical trial results were never published in China, Japan, South Korea, and Taiwan, but discovered that:

“One of the significant issues was the difficulty in determining study completion status. When data was extracted from various registries into the ICTRP platform, differences in registry formats led to the inability to retrieve study completion status, with only ‘recruitment status’ information being available.”

“When accessing the original registry URLs allowed for direct review of each registry, it was easy to find study completion information on ClinicalTrials.gov. However, for other registries, it was challenging to identify clear study completion status or dates. Thus, we were not able to comparatively assess result reporting rates for the registered trials in different countries.”

A recent Cochrane review drawing on data from over 200 studies found that 47% of all clinical trial results ‘worldwide’ are not made public, but the underlying studies overwhelmingly focused on the North Atlantic area, leaving open the question of how Chinese (or Indian, or Japanese) trials perform.

This enduring knowledge gap is partly due to shoddy registry infrastructure, but also because most regulatory scientists and meta-researchers remain myopically focused on Europe and North America.

The global registry mess 

Such long-standing weaknesses in the global registry infrastructure undermined Covid response efforts worldwide, and continue to bedevil efforts to gain an overview of ongoing medical research and new medical discoveries.

(For example, why did it require a complex study to discover how many clinical trials are being run in East Asia and which disease areas they focus on?)

The study team concluded that:

"Many studies, including even RCTs, were not registered prospectively… A critical issue that emerged during our analysis was the need for better quality control in trial registries…"

“[I]nconsistent formatting across registries, including variations in how information was recorded, posed significant challenges in data standardization for crosscountry comparisons. For example, categorizations related to study design, such as allocation and randomization, varied greatly between registries.”

“In [the Chinese registry] ChiCTR, target sample sizes for the control group and multiple intervention arms are presented in text format, not provided as a total number. This required additional effort during data extraction. Without proper standardization of integrated trial data and stronger quality controls, the risk of inaccurate or incomplete trial registrations increases, potentially leading to misinterpretations."

"Therefore, enhanced registry protocols and appropriate quality controls are crucial, not only to ensure data accuracy and completeness but also to foster global collaboration and transparency in clinical trials.”

WHO to the rescue? 

The World Health Organisation recently published new guidance on reporting results in clinical trial registries, which includes a requirement for registries to have a field for completion dates.

However, it is unclear when WHO's new guidance will be adopted by the many registries feeding data into WHO’s global database.

The study “Registered clinical trial trends evolved differently in East Asia vs the United States during 2014-2023” is available online behind a paywall. It was not pre-registered but otherwise appears robust. The authors made their underlying data and some code available in an open access repository.

The authors used data from the World Health Organisation’s global ICTRP database, the American ClinicalTrials.gov registry, and registries in China, Japan, South Korea, and Taiwan. The team removed duplicates from the dataset and categorised RCTs by location, target enrolment size, and disease category.