Adaptive clinical trials can reduce time-to-market and cut development costs
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
Read moreAdaptive 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:
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)
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.
Read moreTechnological infrastructure is key in adaptive clinical trials to ensuring study efficacy and integrity. Download our whitepaper to learn:
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.
How can you strategically apply MCP-Mod in adaptive analysis to streamline your trial? Learn more in our blog.
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