

Thought Leadership
Our latest thinking
Novel designs that use adaptive, Bayesian and other innovative methods play a key role in clinical trial strategy. They can increase trial efficiency, bolster power, support resource allocation and reduce costs. Strategic use of these methods enhances the likelihood of identifying a true clinical benefit which ultimately accelerates patient access to effective therapeutics. Evolving technologies, novel statistical methods, increases in computational power, and the evolving Regulatory Framework enable and encourage innovative development approaches.


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Cytel has pioneered several of the most commonly used Bayesian and frequentist Adaptive Methodologies in practice today, with customer success stories spanning the design, submission, and execution of complex innovative trials, including adaptive pivotal trials leading to FDA and EMA product approval. We help our clients to improve trial pre-planning, and achieve greater trial efficiency, safety, knowledge, and outcomes. We demonstrate ways to identify opportunities while maintaining full scientific rigor.
Innovative Designs are applicable to both exploratory and
confirmatory trials for drugs, biologics, devices and diagnostics. Complex Innovative Designs allow for more efficient use of resources and better management of uncertainties such as treatment effect size, variability, population, doses and clinical endpoints. Using Bayesian and frequentist methodologies we identify the most appropriate design to meet your specific trial, program and portfolio needs.


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Adaptive Design Publications
Other Resources: Adaptive Trials at the Mainstream of Drug Development (2018)

Bayesian Design Publications
Other Resources: New Directions in Bayesian Methods (interview), Adapt & Update the Benefits of Bayesian(interview)

Master Protocols Publications
Other Resources: Statistical Innovation Could Elevate Global Clinical Trials (interview)
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