Complex Innovative Designs :

Navigating the path to increase efficiency, reduce cost and de-risk your clinical development

100-Percent-approval_SC_web_graphicComplex Innovative trials using adaptive, Bayesian and other novel designs can increase efficiency and reduce costs. They enhance the likelihood of identifying a true clinical benefit, and accelerate patient access to good health technologies. Evolving technologies, novel statistical methods, increases in computational power, and the evolving Regulatory Framework enable and encourage Innovative Development approaches.

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.  For a deep dive into the benefits and practical applications of adaptive strategies, please download our comprehensive white paper

Many of our clients choose to engage Cytel in early planning to advise on crucial trial and program design decisions.  We support you from exploratory to confirmatory development and act as your expert guide helping you to navigate the statistical aspects of regulatory interactions.

Our services:

  • Identifying appropriate Innovative design methodologies for your clinical development needs 
  • Trial or Portfolio simulation and optimization
  • Support for regulatory interactions
  • SAP and Protocol development support
  • Data Monitoring Committee support 
  • Interim analysis support and guidance on interim decision-making 
  • Guidance on the logistical and operational implementation of adaptive designs
  • Data collection, statistical analysis and reporting for adaptive trials  

Examples of Complex Innovative Trial Designs

  • Adaptive Dose-Finding
  • External Controls
  • Master Protocols
    • Basket Trials
    • Umbrella Trials
    • Platform trials
  • Model-based dose escalation and cohort expansion
  • Multi-Arm, Multi-Stage (MAMS)
  • Multiple Comparison Procedure Modeling (MCPMod)
  • Population Enrichment
  • Sample Size Re-Estimation

 

Additional Reading:

  • Mehta, Adaptive Designs for Clinical trials, NEJM 2016
  • FDA Complex Innovative Trial Designs (CID) Pilot Program
  • ICH E20: Adaptive Clinical Trials Concept Paper
  • FDA Draft Guidance on Master Protocols

 

Resources

White Paper: Adaptive Designs for Clinical Trials

In this paper updated for 2019, the Cytel Strategic Consulting team outline the new face of adaptive trials in modern drug development.

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Webinar: Adaptive Dose-Finding Designs Improving Drug Development Strategies

In this webinar Cytel Consulting Statistician, Jim Bolognese shares his considerable Phase 2 development experience first with a brief overview of Adaptive Design

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Briefing Note: Adaptive Designs Draft Guidance 2018 vs 2010

In this exclusive briefing note, Natasa Rajicic, Principal Strategic Consulting at Cytel summarizes the key similarities and differences between the two documents.

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