Much of the data on global health conditions is not collected locally in developing countries. Instead, it is extrapolated from data on wealthy, Western populations, leading to biased models and a flawed understanding of disease prevalence worldwide.

While Akiso's Harmony 6 trial in China showed a survival benefit for its PD-1/VEGF bispecific with chemotherapy, it doesn't resolve the key question of whether these impressive results from Chinese populations will translate to a global patient population.

With half its patients from Asia and only 13% from North America, the Destiny Breast 11 trial's results may not be fully generalizable to US patients. Differences in metabolism, healthcare systems, and side effect reporting across regions can impact outcomes, a key consideration when interpreting global trial data.

While speed is crucial in clinical trials, the ability to transfer data across borders is a growing pain point. Data privacy regulations, particularly in China, complicate due diligence and global collaboration, making data portability a key factor for efficiency and a significant hurdle for M&A.

Despite strong efficacy data, the drug DV-Toripalimab scored lower than a competitor (2.5 vs 3.0). Experts attribute this confidence gap to its Phase 3 trial being conducted only in China, which raises generalizability concerns and reflects a lack of hands-on experience for Western physicians.

Despite statistically significant results, Akiso's successful China-only study faced skepticism due to its trial design. Exclusions of older patients and those with high bleeding risk cast doubt on whether the positive findings can be replicated in a diverse global population, posing a barrier to wider acceptance.

The STARGLO trial (glofitamab-gemox) showed a strong survival benefit in Asia-Pacific patients but not in the small North American cohort. This geographic discrepancy, with only 9% of patients from the US, was a key reason the FDA did not approve the combination, while European agencies did.

The FDA is requiring higher US patient enrollment in global trials to address concerns that results from predominantly non-US populations (e.g., Asia) may not be generalizable. This reflects worries about differences in prior standard-of-care treatments and potential pharmacogenomic variations affecting outcomes.

Amidst growing uncertainty at the US FDA, biotech companies are using a specific de-risking strategy: conducting early-stage clinical trials in countries like South Korea and Australia. This global approach is not just about cost but a deliberate move to get fast, reliable early clinical data to offset domestic regulatory instability and gain a strategic advantage.