Are Clinical Trials in China Reliable? What CEOs Say Now

Biotech chief executives in 2026 largely treat clinical data coming out of China as good and reproducible. That is a reversal from roughly ten to fifteen years ago, when the same industry had active doubts about the quality and veracity of Chinese science and often chose to stay away from it. The change is not a policy shift or a marketing claim; it is a change in what senior operators say to each other privately.

Sara Jane Demy is in an unusual position to report it. She founded Demy-Colton in 2008 and runs Biotech Showcase, BioFuture and the Biotech CEO Summit, which means she spends her working life in rooms where biotech CEOs talk candidly about where they are actually placing work.

Do biotech CEOs trust clinical data from China?

Her answer is that the belief has shifted, and that it is now backed by demonstration rather than assertion.

there is a belief that the science is good and a demonstration that the science and the information that comes out of China is good and reproducible

Reproducible is the threshold. Trust in a dataset is not really trust in a country; it is a judgment about whether a result will hold when someone else runs it. That is the threshold her members describe as having been crossed.

What did the industry think before?

Demy is direct about the previous position, and she does not soften it.

people had doubts about the quality and the veracity of the science and the reports coming out of China, so people wanted to stay away from that

That was the working assumption for years, and it shaped where programs went. The reversal is ordinary in structural terms: a jurisdiction builds capability, produces results that survive scrutiny, and the reputational lag closes some years later. The interesting question is not that it happened but how quickly the operating behavior followed.

Demy is careful with her own language here, and it is worth preserving the care. She reaches for the word sketchy to describe the old perception and then immediately withdraws it as unfair, which is a more accurate description of what the doubt actually was. It was not an accusation of fraud. It was uncertainty about whether a result would replicate, which is a normal thing to hold about any unfamiliar source of data and a normal thing to revise when the evidence accumulates.

Why are companies running trials in China?

The stated reasons are unglamorous and practical.

It's more cost effective. It's more cost effective and time effective.

Cost and speed are the two variables that most often decide whether a small company reaches its next inflection point before its money runs out. Where that money now comes from has itself shifted, which the same two guests take up in their account of family offices deploying directly rather than through funds. When a jurisdiction improves on both and the data is accepted, the decision stops being ideological and becomes arithmetic. Demy frames China as somewhere her members now consider both for running trials and for sourcing research.

as the place where one can go to do clinical trials and get data out that is good data

What is driving the shift?

Demy attributes it to deliberate change rather than drift, noting that certain changes have been made and the results followed. That is consistent with the broader industrial strategy her co-guest Jeremy Levin describes, in which trial infrastructure and the regulator were built up alongside manufacturing and capital as part of one plan. We cover that argument in detail in our piece on China's biotech strategy and its 2035 target.

The practical read is that clinical capability was a deliberate build, not a by-product of cheap labor, which is what makes the credibility durable rather than cyclical.

What does this mean for a US biotech deciding where to run a trial?

It means the question has moved from whether the data will be believed to whether the rest of the decision holds up. Data acceptance was the blocking issue for years; with that resolved, the remaining considerations are the ordinary ones. Regulatory pathway, intellectual property exposure, supply-chain dependency, the completeness of adverse-event reporting and the expectations of your own investors all still apply, and none of them are settled by the quality of the science.

Those questions are live and unresolved. We have written separately on how intellectual property is exposed in China and on alternatives to Chinese biotech suppliers, and nothing in this conversation resolves them. What it does establish is that "the data is not trustworthy" is no longer the industry's working objection.

Are adverse events in Chinese trials fully reported?

Three deaths in Chinese gene-editing trials went undisclosed, two of them children. On August 20, 2026, Representatives John Moolenaar and Ben Cline asked the FDA to decline China-generated data in IND, NDA and BLA submissions unless the agency has audited the trial site in person within the previous twelve months.

China's investigator-initiated pathway removes the up-front regulatory gate, leaving oversight to the hospital ethics board, and companies use it before carrying the results into a US filing. Reproducibility is a claim about whether a published result holds when someone else runs it, and it assumes the published record includes the results that went badly.

What should you not conclude from this?

That the debate is over. Demy is reporting what CEOs in her rooms say, which is strong evidence about industry sentiment and about revealed behavior, and is not the same as an audited comparison of trial quality across jurisdictions. A reader deciding where to place a pivotal study should treat this as a signal about where the industry has moved, and do the diligence anyway.

This account is drawn from the recorded, on-the-record conversation on Open Door Salon with Sara Jane Demy and Jeremy Levin, hosted by Lori Ellis. Interested in sponsoring Open Door Salon?