Mohit Manrao, SVP, Head of US Oncology at AstraZeneca, shared on LinkedIn:
“Only 7% of U.S. adults with cancer are enrolled in a clinical trial. Are we really unlocking the full potential of this golden era of oncology innovation without greater trial participation?
Clinical trials bridge scientific discovery and patient care. They show whether a promising treatment is safe and effective for the people it’s meant to help. Right now, too few patients can cross that bridge, and trials don’t yet reflect the full diversity of people living with cancer.
These challenges are not insurmountable. Progress takes collaboration across policymakers, providers, patient advocates and industry.
Three opportunities stand out:
1. Make clinical trials more accessible to patients
Today, many trials start at major academic medical centers. These centers are vital to research, but many patients receive cancer care closer to home, like in community settings. Stronger partnerships between research centers and community providers can help more patients hear about and join trials without long travel or additional life disruptions.
Legislation can help bring trials within reach of more patients. The bipartisan Clinical Trial Modernization Act (CTMA) would remove key barriers to participation by:
- Reducing financial barriers: Letting sponsors cover participants’ costs, including travel, lodging, meals, and co-pays for trial drugs or devices.
- Enabling remote participation: Allowing sponsors to provide free digital health tools, such as remote monitoring devices or apps, without running afoul of federal Anti-Kickback rules.
- Protecting stipends: Excluding up to $2,000 a year in participant stipends from taxable income and from income limits for programs like Medicaid.
- Funding community outreach: Authorizing HHS to award grants for local education, recruitment, and infrastructure.
2. Accelerate early-phase development
Early-phase trial sites navigate extensive requirements that can affect start-up timelines and investment decisions. There is an opportunity for federal policymakers to lead in streamlining processes while preserving essential safeguards for participant safety and data quality, including:
- Modernizing the FDA’s Investigational New Drug (IND) process, the approval step before human testing, to make it clearer, more predictable, and faster.
- Updating FDA preclinical requirements for early-stage trials while retaining safeguards for participant safety and data quality.
- Encouraging digital, data-driven, and AI-enabled tools across regulatory submissions and reviews to improve the speed, quality, and consistency of FDA decision-making.
3. Sustain U.S. leadership in biomedical innovation
Modernizing trials is essential, but so is sustained investment in research institutions, workforce development, and manufacturing capacity. These take time to build and require long-term commitment from
- policymakers
- academia
- healthcare
- industry.
AstraZeneca is investing $50 billion across our U.S. manufacturing and R&D footprint by 2030 because we believe America’s biomedical leadership is a strategic advantage worth strengthening.
Looking ahead
Countries that lead in biomedical innovation will be better positioned to improve health outcomes, drive economic growth, and compete globally.
The U.S. has all the ingredients to lead in bringing the world’s most promising innovation to patients. By moving together to modernize trials, expand access, and sustain long-term investment, we can help ensure scientific advances have the greatest possible impact for patients.
What do you believe is the single most impactful step we could take to make clinical trials more accessible to patients?”
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