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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

Adaptive Designs for Clinical Trials (2016) by Cyrus Mehta et al., NEJM
 
Adaptive Increase in Sample Size when Interim Results are Promising (2011) Cyrus Mehta & Stuart Pocock Statistics in Medicine
 
Optimal Adaptive Promising Zone Designs (2022) by Cyrus Mehta, Apurva Bhingare, Lingyun Liu and Pralay Senchaudhuri Statistics in Medicine.
 
Robust Group Sequential Designs (2022) by Cyrus Mehta, et al. Biometrical Journal

 

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

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Bayesian Design Publications

Bayesian Methods in Pharmaceutical Research (2020) by Yannis Jemiai, et al. Chapman & Hall
 
Hi3+3: A model-assisted dose finding design borrowing historical data (2021) by Yuan Ji, et al., Elsevier
 
Simulation for Bayesian Adaptive Designs (2019) by Kyle Wathen in Bayesian Applications in Pharmaceutical Development.

 

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

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Master Protocols Publications

Adaptive Multiarm Multistage Clinical Trials (2020) by Cyrus Mehta et al. Biometrics.
 
Effect of Early Treatment with Hydroxychloroquine or lopinavir and ritonavir on risk of hospitalization among patients with COVID-19 (2021) by Ed Mills, et al., JAMA 
 
Effect of Early Treatment with Fluvoxamine on Risk of Emergency Care and Hospitalization Among Patients with COVID-19 (2021) by Ed Mills, Ofir Harari, Jamie Forrester, et al. Lancet

 

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

Recent Publications

Key Publications
2022
2021
2020
2019
2018
2017
2016

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Publications

Access a comprehensive list of Cytel publications over the last decade. 

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