Adaptive Clinical Trials

Adaptive clinical trials can reduce time-to-market and cut development costs

An introduction to applications of adaptive design

An introduction to applications of adaptive design

An adaptive design clinical trial can help to create a stronger value proposition for your product and give you a competitive edge, by reducing development costs and accelerating time-to-market. How can you apply adaptive design to empower your clinical trial? To get started, read our blog: An introduction to applications of adaptive design

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Operational Challenges in Adaptive Trials

Operational Challenges in Adaptive Trials

Adaptive design is a novel clinical trial approach that is supposed to maximise efficiency and portfolio value. In the Operational Challenges of Adaptive Trials: Integrated Technology and Best Practices for Successful Implementation white paper, you’ll discover:

  • How to overcome three critical operational challenges that could prevent success in an adaptive clinical trial
  • Four criteria you should fulfil in order to ensure a robust technology infrastructure for adaptive design
  • Several real-world examples of adaptive design errors and how to fix them
Download the whitepaper
Adaptive design case studies

Adaptive design case studies

Avoid three key sources of operational error in adaptive trials

Case study one: Despite early signs of efficacy, an adaptive Phase III superiority trial for a new chronic graft-versus-host disease treatment failed after being halted. Learn how the erroneous early stopping decision could have been prevented. (PDF)

Case study two: A randomised, double-blind Phase III non-inferiority trial of a new treatment for acute infectious diarrhoea against a comparator employed an adaptive design calling for two interim analyses to adjust sample size. (PDF)

Case study three: Mitigating development risks through adaptive design. (PDF)

Regulatory agencies encourage use of adaptive designs

Regulatory agencies encourage use of adaptive designs

Over the past several years, regulators, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Device Agency (PMDA), have provided guidance on the use of adaptive design for clinical development, which has accelerated industry adoption of adaptive design trials. The FDA's Critical Path Initiative identifies adaptive design as key to improving trial efficiency. Adaptations include sample size optimization and changing allocation based on the optimal dose and dose-response curve.

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FLEX Advantage

Supporting efficient and compliant adaptive clinical trials

Technological infrastructure is key in adaptive clinical trials to ensuring study efficacy and integrity. Download our whitepaper to learn:

  • How the FLEX ADVANTAGE platform facilitates crucial processes, including complex what-if scenario modelling and precise statistical analysis
  • Why the integration of FLEX ADVANTAGE with electronic data capture can expedite data-cleaning and enhance risk-based monitoring
  • How FLEX ADVANTAGE is used to maintain study blinding, ensure data analysis integrity, and accelerate decision-making in real-world adaptive clinical trials

Adaptive design for medical devices: The faster path to market

Adaptive design allows for pre-set interim analyses to assess efficacy, treatment effect and other critical data, allowing you to make better, more informed development decisions.

Adaptive MCP-Mod adds powerful dose-finding capabilities to ADDPLAN® neo

Adaptive MCP-Mod adds powerful dose-finding capabilities to ADDPLAN® neo

How can you strategically apply MCP-Mod in adaptive analysis to streamline your trial? Learn more in our blog.

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