Westat’s clinical trials design and analysis team works with sponsors and therapeutic subject matter experts to design efficient, rigorous clinical studies that ensure high probability of success in securing regulatory approvals and scientific acceptance.

Research-Based Recommendations

Our team works to ensure thorough understanding of your research questions and hypotheses to be tested in order to design optimal clinical trials that are both time and cost efficient. Our solutions may rely on conventional, fixed designs of superiority/non-inferiority/equivalence, or innovative and adaptive designs incorporating biomarkers/diagnostics.

Our biostatisticians collaborate with sponsors and investigators to optimize study designs by:

• Selecting appropriate primary and secondary clinical endpoints
• Developing estimands designed to improve the quality and precision of clinical research
• Determining clinically meaningful differences in endpoints
• Identifying the most appropriate statistical models and methods based on the study’s research questions (i.e., parametric/non-parametric/Bayesian) to test study hypotheses involving diverse clinical endpoint measures (continuous, binary, ordinal, count, rate/proportion, longitudinal/time-to-event)
• Determining optimal sample sizes
• Conducting trial simulations that help determine probability of success

Regulatory Representation

Not only does Westat design and manage optimize trials – we also ensure the resources needed to defend our trial designs to make sure they withstand regulatory scrutiny. Our team is well versed in representing sponsors in regulatory interactions to justify design choices, clinical endpoints, statistical analysis methods, and validity of inferences from trial results. The reliability of this support aids development of clinical study reports as well as publication in high-impact scientific journals.

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