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Empower Your Trial Design with Synthetic Controls
Cytel’s synthetic control arms services enable you to optimize your clinical trial design by leveraging real-world data for more robust regulatory submissions and accelerated therapies.
Synthetic Controls: Transforming Trial Design with Real-World Evidence
Do you need more evidence to support regulatory submission? Our expertise in synthetic control arms (sca) development empowers you to navigate complex regulatory landscapes and expedite the delivery of life-saving therapies to patients in need.
Our SCA solutions revolutionize trial design by leveraging real-world evidence. This approach transforms traditional clinical trial paradigms, offering ethical and cost-effective alternatives to control arms. By harnessing diverse real-world data sources, we help you accelerate regulatory submissions, streamline trial designs, and maximize efficiency. Our SCA solutions redefine trial design methodologies, providing innovative strategies to address your enrollment challenges, ethical concerns, and molecularly defined populations.
Contact usEnhance efficiency
Synthetic controls enable streamlined trial designs, reducing enrollment challenges and accelerating your therapy’s development.
Lower costs
By leveraging existing data sources, synthetic control arms minimize the need for costly control arms to optimize your trial budgets.
Regulatory support
Regulators increasingly accept synthetic control arms, accelerating the approval processes for life-saving therapies.
Ethical enrollment
Synthetic controls give you ethical alternatives in situations where enrolling patients in control arms may be contentious.
When to Consider Synthetic Controls
Synthetic control arms are instrumental in addressing key challenges identified in clinical trial design:
- Enrollment challenges: Are you grappling with enrollment difficulties, hindering the timely execution of your trial?
- Ethical concerns: Do ethical considerations preclude the enrollment of patients into standard control arms, necessitating alternative trial designs?
- Molecularly defined populations: Are you conducting trials in molecularly defined patient populations, where traditional control arms may not be feasible or ethical?
Synthetic control arms offer you a strategic solution in all these scenarios, leveraging real-world data to construct robust comparator arms, ensuring ethical trial conduct, and facilitating meaningful comparisons to advance clinical research.
Demystifying Synthetic Controls
While synthetic control arms can provide a robust comparison, they are not a direct method for filling in missing data within a study. Instead, they serve as a substitute for a control group, enhancing the efficiency of clinical trials, particularly when enrolling a sufficient number of participants for a control group is challenging.
Despite their growing acceptance, several myths about synthetic control arms persist:
Myth 1: Regulatory Acceptance – Despite misconceptions that regulatory bodies do not accept synthetic control arms due to unmeasured confounding and missing data concerns. In reality, regulatory bodies are open to collaboration to address these issues. Synthetic control arms create robust comparative groups by utilizing historical data and real-world evidence.
Myth 2: Expediency – Synthetic controls aren’t swift fixes; they require meticulous planning and execution, but are potentially quicker than traditional controls, especially in rare populations.
Myth 3: Statistical Complexity – While advanced statistics offer solutions, fundamental data issues persist. Regulatory strength lies in interpretable analyses showcasing reasonable effect sizes and consistent results across methodologies.
Myth 4: Limited Applicability – Contrary to belief, synthetic control arms extend beyond oncology, with successful applications seen in non-oncological indications such as gene therapy for spinal muscular atrophy.
Cytel's Comprehensive Capabilities for Synthetic Controls
- We empower your research team to design robust synthetic control arms, leveraging advanced statistical methodologies including propensity scoring, Bayesian dynamic borrowing, and statistical weighting techniques.
- Our expertise includes homogenous and heterogeneous historical data integration to enable the creation of tailored control arms.
- Our meticulous application of statistical principles and rigorous methodological frameworks, ensures reliability and validity.
- We harness the power of real-world evidence and cutting-edge analytical approaches to integrate SCAs seamlessly into your clinical trial designs.
Download our eBook on Synthetic Controls
Read our eBook, where you will discover strategies for constructing synthetic control arms and think through challenges during clinical trial designs. This eBook gives you a framework to explore various uses of data to help improving your clinical development program.
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