Meeting the Clinical Trial Surge of 2025: Why Expanded Access Platforms Matter Now
The first half of 2025 has seen a striking surge in clinical trial activity. Across therapeutic areas, but especially in oncology, companies are advancing more investigational medicines than ever before. According to industry analyses, Phase I and II trials are on the rise, reflecting an unprecedented pipeline of early and mid-stage treatments. At the same time, hybrid trial models, AI-driven design, and decentralized approaches are becoming more common, as sponsors and CROs look to overcome cost pressures and complex regulatory landscapes.
But this rapid growth highlights a sobering truth: many patients who could benefit from these innovations will not gain access through traditional trial pathways. Eligibility criteria remains narrow, trial sites are limited, and time is critical for patients with life-threatening conditions. For them, waiting years for full approval is not an option.
This is where expanded access—also known as compassionate use or early access—becomes essential. And it’s why MedaSystems built a dedicated expanded access software platform to safely, ethically, and efficiently connect patients, physicians, and sponsors in delivering investigational drugs to those who need them most.
The Changing Clinical Trial Landscape
Several key trends are reshaping the research environment:
More investigational drugs in the pipeline. The surge in Phase I and II trials means a growing pool of treatments still years away from approval.
Oncology dominates. Cancer remains the leading focus of trial activity, but progress is also accelerating in CNS, cardiovascular, and rare diseases.
Operational and cost pressures. Sponsors are adopting decentralized trials, AI, and wearables to improve efficiency while managing global regulatory demands.
Patient recruitment hurdles. Trials often exclude patients with comorbidities, advanced disease, or geographic barriers—leaving many with no trial pathway.
These trends are promising for innovation but expose gaps in patient access. Expanded access programs (EAPs) provide a bridge, offering a lifeline for patients who cannot wait for approvals or trial eligibility.
The Promise and Challenges of Expanded Access
Expanded access programs allow patients with serious or life-threatening conditions to receive investigational treatments outside of formal trials, under regulatory oversight. But implementing EAPs is far from simple:
Regulatory complexity. Rules differ across regions, requiring careful navigation.
Safety monitoring. Collecting and reporting data on adverse events is critical.
Supply chain logistics. Investigational drugs require strict handling and tracking.
Stakeholder coordination. Physicians, sponsors, regulators, and patients all need clear communication and documentation.
Cost and liability concerns. Sponsors must balance ethical obligations with operational risks.
Expanded access requests often arise at key inflection points. When positive data is released, when leading investigators or trial sites are involved, or in therapeutic areas that have gone years without new approvals, demand for access can increase sharply. At the same time, sponsors are limited by the need to collect sufficient safety data before offering a drug outside of a clinical trial. In the United States, the 21st Century Cures Act further requires companies to publish an expanded access policy, including clear contact information, procedures, and criteria for evaluating requests (Reagan-Udall summary). These dynamics add another layer of complexity, underscoring the importance of having reliable infrastructure in place to respond to requests in a timely and compliant way.
Without robust infrastructure, expanded access can be difficult to manage at scale. That’s where technology becomes indispensable.
How MedaSystems’ Expanded Access Platform Helps
MedaSystems designed its expanded access platform to remove the friction that sponsors and physicians face when offering investigational drugs under compassionate use. Key capabilities include:
Regulatory support. Automated templates and jurisdiction-specific workflows streamline submissions and ensure compliance.
Eligibility screening. Smart tools help physicians quickly determine patient suitability, reducing errors and improving safety.
Safety monitoring. Real-time reporting captures adverse events, integrating seamlessly with sponsor safety systems.
Supply chain tracking. End-to-end visibility ensures investigational drugs are stored, shipped, and dispensed under proper conditions.
Data capture and integration. Patient outcomes and real-world evidence are collected ethically and transparently, adding value for sponsors and regulators alike.
Scalable infrastructure. Designed to manage multiple programs simultaneously, the platform adapts to different drugs, indications, and geographies.
By combining compliance, transparency, and patient-centric tools, MedaSystems provides a foundation for sponsors to run expanded access programs responsibly and efficiently.
Why This Matters Now
The clinical trial surge of 2025 is a double-edged sword. It signals a vibrant pipeline of potential therapies, but also underscores the urgency of bridging access gaps. For patients with no other options, expanded access is not a “nice-to-have”— it’s a necessity.
Sponsors that embrace expanded access don’t just meet an ethical obligation. They also build trust with patients and advocacy groups, strengthen relationships with regulators, and generate real-world data that can inform development. In an era of rising patient expectations and public scrutiny, having the right infrastructure in place is critical.
Conclusion
As more therapies advance through trials, the industry must rethink how innovation reaches patients in real time. Expanded access programs, once treated as exceptions, are now central to a compassionate and efficient drug development ecosystem.
MedaSystems’ expanded access software platform provides the tools to make these programs safe, scalable, and compliant—helping ensure that patients who cannot wait still have a chance to benefit from tomorrow’s medicines today.
If you’re a sponsor, physician, or patient advocacy group exploring expanded access, connect with MedaSystems to learn how our platform can support your program.