External Control Arms (ECA)

Why and When to Consider External Controls

ECAs offer you a strategic advantage in clinical development by harnessing ​RWD to construct robust comparator cohorts. This approach becomes invaluable when conventional trial designs encounter obstacles such as rare diseases, ethical constraints, or constrained patient populations. ECAs provide a pathway to overcome these challenges by allowing you to leverage diverse RWD sources to assemble representative comparator groups. By incorporating real-world evidence (RWE), ECAs enhance the generalizability and relevance of your trial findings, facilitating regulatory acceptance and informing treatment decisions. This adaptable approach ensures efficient and ethical conduct of your clinical research across a spectrum of complex medical conditions.

A Comparative Analysis Approach from RWD to ECA Design

Data landscaping: Identify eligible RWD databases for comparator cohort selection. 

Data feasibility: Conduct in-depth assessments to qualify selective data sources and define comparator cohorts. 

Retrospective design: Select comparator cohorts based on existing RWD to enhance trial efficiency. 

Innovative RWE solutions: Develop statistical analysis plans and perform ECA analysis, incorporating Bayesian borrowing and quantitative bias analysis methodologies. ​​Find out more about our RWE solutions. 

Probabilistic sensitivity analysis: Simulate the effects of bias adjustment, ensuring robustness and reliability of ECA results.