The Case for Accelerating Clinical Drug Trials in the United States ‍

‍Maryam Mujica is the President of General Catalyst Institute. Kent Thoelke is the Founder and CEO of Paradigm Health, a General Catalyst portfolio company. ‍

For decades, the United States has been a global leader in biomedical innovation, but we risk that position because our clinical research infrastructure is old, slow, fragmented, and administratively burdensome. Other nations like China, Australia, and India have increased their trial capacity and are now tough U.S. competitors. China, specifically, has created faster and cheaper systems for conducting clinical research, backed by key regulatory changes.

If the United States wants to remain the world’s center for therapeutic innovation, it must modernize how clinical research is conducted.

Currently, clinical trials take far too many years, are prohibitively expensive, and are overly complex. Slower, more expensive trials in the United States lead to higher medicine costs, delayed or limited access to new therapies for American patients, and ultimately, a growing reliance on other countries to address Americans’ health needs.

In clinical development, time is money. Each day a trial continues is estimated to cost approximately $40,000 in direct costs and nearly $500,000 in unrealized or lost prescription drug sales. The cost per novel drug has risen significantly in the last decades, from an average of less than $1B in the 1990s to $3.5B today. These rising costs reflect delays as trial sponsors struggle to find sufficient sites with eligible patients; clinical research teams are burned out by the excessive administrative burden that trials impose; and trial staff battle with fragmented data systems.

If the United States wants to remain the world’s center for therapeutic innovation, it must modernize how clinical research is conducted.

The Chinese government recognized this inefficiency early, and between 2014 and 2024, nearly tripled its spending on research and development and accelerated regulatory review of clinical trials. The results of that investment are significant. A recent report shows that costs for Phase 3 trials in Non-Small Cell Lung Cancer are at least $69,000 per U.S. patient, whereas in China it’s $25,000 per patient. In late-stage trials, Chinese patient recruitment is 2 to 5 times faster than recruitment in U.S. trials. Their large public hospital systems and centralized referral networks allow Chinese researchers to screen and enroll larger patient pools quickly. 

The government cannot modernize alone. Bolstering our national clinical development infrastructure requires shared investment. Now is the time to build on this momentum, and for trial sponsors, clinical research leaders, and health system decision makers to unite around essential actions.

‍First, trial sponsors must make U.S. clinical trials more practical for patients in need of treatment options and for investigators whose research responsibilities are added on top of their patient care responsibilities. This will allow more health centers—not just urban academic medical centers—to conduct research and more patients to access trials. A recent pilot study sponsored by Johnson & Johnson shows how this can be done. The pilot leverages EHR-embedded technology to streamline data collection and support patient identification and enrollment, all while preserving the data quality required for clinical decision-making. Patients were enrolled quickly across multiple U.S. community oncology sites, with participation reflecting the diversity of populations treated in routine care. 

‍Second, the industry must learn from Real-Time Clinical Trials as they are in process and move away from post-trial data analysis, which can happen months, even years after the first patient enters a trial. Paradigm Health has engineered the infrastructure for this landmark collaboration, working closely with the FDA since early 2026 to define reporting and validation standards, establish criteria for key regulatory events, and ensure FDA-Paradigm Health software and data interoperability. The data transferred through the real-time platform is traceable, auditable, and protects patient privacy, while minimizing the transfer of unnecessary datasets. The proof of concept trials with Amgen and AstraZeneca will provide a blueprint for the next phase of this initiative.

‍Third, health systems need to adopt AI-enabled solutions to increase efficiency and data quality. With today’s technology, we can connect disparate databases from trial sites, sponsors, and regulatory bodies, and automate tasks that are onerous and easily introduce transcription errors. These AI solutions can act as an antidote to the clinical researcher burnout that pervades the American clinical research industry. Take this recent example with Ochsner Health, in which they used Paradigm Health’s AI-native platform to extend the reach of their research team by 41%.

‍Finally, as a collective industry, we must prioritize broad U.S. distribution of clinical trials. Trial sponsors must broaden their study sites beyond their battle-tested academic medical centers. Community and rural sites, like Highlands Oncology Group and Florida Cancer Specialists & Research Institute, are where the vast majority of Americans receive care. Expansion to community and rural health centers will yield long-term benefits including more representative evidence, faster enrollment and, potentially, trial completion. Clinical research should be a care option for Americans no matter where they receive care.

The countries that move fastest to build efficient, connected, patient-centered clinical research systems will shape the future of global healthcare—and have the healthiest people. 

With support from investors like General Catalyst, Paradigm Health has built an infrastructure that connects biopharmaceutical sponsors with trial sites and regulators, connecting more patients and health centers with clinical trial opportunities. We have shown that collaboration across government, academia, biopharma, and technology works. We now must move quickly to scale these efforts. The countries that move fastest to build efficient, connected, patient-centered clinical research systems will shape the future of global healthcare—and have the healthiest people.