Why global sponsors are increasingly including China early in multi-regional clinical trials
Rare disease drug development has become a truly global effort. Sponsors are under constant pressure to identify patients faster, reduce development timelines and generate robust data that supports regulatory submissions across multiple regions.
As a result, clinical development strategies are evolving.
Rather than treating China as a market to be addressed after approvals are secured elsewhere, many organizations are incorporating China into clinical programs earlier than ever before. This shift is transforming how rare disease trials are designed and executed on a global scale.
Why sponsors are moving beyond the China-after-approval model
Historically, multinational companies often completed substantial portions of development before expanding into China. Local studies or bridging requirements were frequently added later as part of the registration process.
While this approach aligned with the regulatory realities of the past, it could introduce inefficiencies and delays. Regulatory reforms, expanded clinical infrastructure and greater acceptance of global development models have created an environment where earlier inclusion is increasingly possible and often advantageous.
Today, many sponsors are evaluating China alongside other major markets during the earliest stages of clinical planning.
The recruitment challenge in rare diseases
One of the primary drivers behind this shift is patient recruitment. Rare disease studies frequently struggle to identify enough eligible participants. Patient populations are often fragmented across multiple countries and sites may compete for the same individuals.
China offers access to one of the world's largest rare disease populations, with more than 20 million people affected by rare diseases.1 Combined with improving diagnostic capabilities and expanding specialist networks, this creates important opportunities for recruitment. Including China from the outset can broaden access to patients and potentially accelerate enrollment timelines.
How early inclusion supports efficient global clinical development
Early inclusion can also simplify development planning. China now encourages participation in global studies beginning in early clinical development. Sponsors who incorporate China into Phase I or Phase II programs may reduce the likelihood of additional studies later in development and create a more coordinated evidence package for regulatory review. This approach supports a more streamlined path from development through commercialization.
Faster startup timelines and evolving infrastructure
China's clinical research ecosystem has matured considerably in recent years. The country has expanded its clinical trial infrastructure, strengthened research capabilities and developed networks of experienced investigators.2 Regulatory review timelines have also shortened, creating opportunities for more efficient study startup compared with historical benchmarks.
These improvements have made China a more practical option for global sponsors seeking high-performing sites and reliable enrollment contributions.
Building relationships earlier
Clinical development does not end with study completion. Introducing a therapy into a new market ultimately requires engagement with regulators, investigators, healthcare providers and patient communities. By involving China earlier in development, sponsors can begin building these relationships long before potential commercialization activities begin.
Early engagement may also provide valuable insights into local clinical practice, patient needs and future market considerations. This increasingly integrated approach reflects a broader industry trend toward aligning research, regulatory planning and commercial strategy from the beginning of development.
Operational advantages of including China in global clinical trials
Sponsors are also paying closer attention to development efficiency. China often offers lower operational costs compared with some Western markets while providing access to sophisticated clinical research infrastructure and established trial sites.3 When combined with recruitment opportunities and regulatory reforms, these factors can contribute to more efficient development strategies. While cost should never be the sole driver of site selection, it remains an important consideration when planning large and complex global programs.
The strategic cost of waiting
Perhaps the strongest argument for earlier inclusion is the opportunity cost of delay. Waiting until late-stage development to involve China may result in missed recruitment opportunities, additional operational complexity and reduced alignment across global development activities. Sponsors may also lose valuable opportunities to engage with investigators, regulators and healthcare stakeholders earlier in the product lifecycle.
For many organizations, the question has shifted from whether China should be included to how quickly it should become part of the development strategy.
How China is reshaping global rare disease development
Rare disease development requires sponsors to think globally, move quickly and make the most of every patient opportunity. China's expanding patient base, evolving regulatory environment and increasingly mature clinical research ecosystem have positioned the country as a valuable component of modern multi-regional clinical trials.
As more sponsors adopt globally synchronized development strategies, early inclusion of China is becoming more than an operational decision. It is becoming a strategic advantage.
Learn more about how Fortrea can support your rare disease study.