Medidata AI's Synthetic Control Arm (SCA®) is an innovative solution designed to provide external control arms for clinical trials using extensive historical data. By leveraging data from over 30,000 clinical trials and 9 million patients, SCA addresses challenges in recruiting traditional control groups, particularly in rare or life-threatening diseases. This approach not only accelerates clinical trial timelines but also ensures scientifically robust comparisons, ultimately aiding in regulatory submissions and improving patient outcomes.

Key Features

Comprehensive Data Utilization SCA employs a vast database of historical clinical trial data to construct control arms.

• Access to data from 30,000+ trials.
• Inclusion of patient-level data from 9 million patients.

Statistically Rigorous Design The SCA uses advanced statistical methods to ensure comparability between experimental and control groups.

• Dynamic matching process based on demographics and disease characteristics.
• Balanced baseline composition for accurate comparisons.

Regulatory Support Facilitates discussions with regulatory bodies by providing evidence-based comparisons.

• Enhances single-arm Phase II trials and supports accelerated approval submissions.
• Collaborates with teams experienced in regulatory processes.

Benefits

Enhanced Trial Efficiency The SCA streamlines patient recruitment and retention efforts.

• Reduces the burden of finding suitable control groups.
• Enables faster enrollment and potentially quicker access to new treatments.

Improved Scientific Validity Provides more reliable control group comparisons than traditional literature searches.

• Leverages real-world evidence for better-informed decision-making.
• Supports hybrid models that combine external controls with standard arms.