Bringing New Treatments to Patients Faster with Regulatory-Grade Synthetic Control Arms

Bringing new treatments to market faster, expanding patient access, and reducing development costs - these are just some of the benefits offered by Regulatory-Grade Synthetic Control Arms (SCAs). This innovative approach looks at real-world data to create robust control arms in clinical trials, facilitating more efficient and effective drug development process.

Challenges in Traditional Clinical Trials

Traditional clinical trials face challenges that can significantly delay getting new treatments to patients. These challenges include:

• Slow Enrollment: Finding enough participants with the specific characteristics needed for the study can be a lengthy and challenging process.
• Ethical Considerations: Exposing some patients to a potentially less effective standard treatment can raise ethical concerns.
• High Costs: The traditional trial design can be expensive due to the need for a separate control arm and large patient populations.

How SCAs Address These Challenges

SCAs make use of real-world data (RWD) from sources like electronic health records, disease registries, and medical claims databases. Researchers can identify patients with similar characteristics to those in the planned clinical trial by evaluating this vast amount of information. Statistical techniques such as Propensity Score Matching, Inverse Probability Weighting, Causal Inference Modeling, etc. are then used to create a virtual control arm whose outcomes can be compared to the new treatment group.

Benefits of SCAs in Clinical Drug Development

• Faster Development: By eliminating the need for a separate control arm enrollment process, SCAs can significantly accelerate trial timelines, bringing new therapies to patients sooner.
• Wider Patient Access: More patients can be placed in the new treatment arm, potentially benefiting from the investigational drug.
• Reduced Costs: The reliance on existing data can substantially reduce the overall cost of clinical trials.
• Ethical Considerations: Fewer patients are exposed to potentially less effective standard treatments.

How Maxis Clinical Sciences (MCS) Can Help

We bring deep expertise and a collaborative approach to help you utilize RWD/E for faster drug development. Our RWE experts enables you to design and implement robust, regulatory-compliant SCAs for your clinical trials.

• Data Acquisition and Integration: Our team has expertise in accessing and integrating high-quality RWD from various sources, ensuring data accuracy and relevance for your specific SCA needs.
• Target Population Identification: We use advanced analytics to identify a virtual control arm that closely matches the planned clinical trial population, ensuring robust comparisons.
• Statistical Modeling and Analysis: Our team of statisticians employs rigorous methodologies, including propensity score matching and causal inference modeling, to create a reliable SCA and mitigate potential biases.
• Regulatory Expertise: We stay up-to-date on evolving regulatory guidance for SCAs and ensure your RWD-based control arm meets all regulatory requirements for successful submission.

Want to Learn More?

If you are a stakeholder in Clinical Research / Clinical Trials Studies (Sponsors, CROs, Research teams, Regulatory experts, or Study investigators) or Healthcare Decision-making (Payers, HTA agencies, or Patient advocacy groups), Maxis Clinical Sciences can help you utilize the power of SCAs to accelerate drug development, improve patient access, and optimize trial design.

Download our detailed Use Case on Synthetic Control Arms to learn about our methodological approach and how they can benefit your clinical studies. Visit this link to access the downloadable content.

If you have any questions or would like to learn more about our methodological approach and how we can support your specific needs, please don't hesitate to connect with us. We'd be delighted to discuss our services in further detail and explore how we can collaborate to drive innovation in clinical research and healthcare decision-making. 

Contact us at info@maxisclinical.com or via our website contact form – Make an appointment