A recent editorial in Frontiers in Drug Safety and Regulation highlights a major shift in clinical research: over 50% of single-arm HTA submissions between 2011 and 2019 included some form of external control data—a clear sign of ECAs’ growing importance for regulatory and payer decisions. 

ECAs leverage real-world data (RWD)—from electronic health records, patient registries, and historical clinical trial data—to create comparator groups, making studies more feasible and inclusive, especially for rare conditions.

Clinakos Inc. is uniquely positioned to unlock the full potential of ECAs with:

🔹 Curated, High-Quality Real-World Data

Clinakos aggregates and harmonizes patient-level data from diverse sources, ensuring robust and representative external controls.

🔹 Advanced Cohort Matching with AI

Our platform uses AI-driven analytics to precisely match trial participants with external controls, enhancing statistical rigor and regulatory acceptance.

🔹 Accelerated Timelines

Rapid cohort identification and validation help reduce trial duration, overcome recruitment challenges, and speed therapies to market.

🔹 Ethical & Operational Benefits

By minimizing traditional control arm enrollment, we address ethical concerns and operational hurdles—especially in rare diseases and oncology.

Let’s connect and explore how Clinakos can empower your next clinical trial! 

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👉Read the full report here