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Adaptive clinical trials

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

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
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Flex Advantage - Executing efficient and compliant adaptive trials

Flex Advantage: Executing efficient and compliant adaptive trials

Adaptive clinical trials offer many potential benefits, improving therapy development efficiency while reducing time and cost. The unique operational demands of adaptive trials, however, involve greater complexity, speed and blinding requirements than existing trial infrastructure can support. Furthermore, attempts to augment existing trial infrastructure with manual processes that support adaptive decision-making, such as changes to randomisation or drug supplies, can still undermine trial integrity and may not meet regulators’ expectations.

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ADDPLAN® DF designing more accurate dose escalation studies

ADDPLAN® DF designing more accurate dose escalation studies

The accurate estimation of the MTD is of critical importance in the drug development process. This white paper discusses innovative dose escalation designs and their implementation in ADDPLAN® DF. The aim of the software is to support the process of decision making in the design and analysis of dose finding trials using these innovative methods. Uncertainty in the true underlying dose-toxicity profile needs to be taken into account when designing efficient and effective dose escalation trials. ADDPLAN® DF enables drug developers to study the operating characteristics of standard and innovative dose escalation methods under different scenarios, allowing the selection of the appropriate methods for successful Phase I dose escalation trials.  

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Using adaptive design to optimise product development at the programme and portfolio level

Using adaptive design to optimise product development at the programme and portfolio level

This whitepaper provides insight into adopting an adaptive design strategy at the level of the product portfolio. It has been written to help senior R&D decision-makers understand the critical role of adaptive design in portfolio decision-making and in appreciating the value that this approach can bring. 

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Adaptive design for medical devices: The faster path to market

Adaptive design for medical devices: The faster path to market

An adaptive design clinical trial can help to create a stronger value proposition for your medical device and give you a competitive edge, by reducing development costs and accelerating time-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.

ICON experts have more than a decade of experience in the design, simulation and execution of adaptive design trials. Our operational teams and specialised technologies enable medical device manufacturers to apply the power of adaptive design.

 

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Adaptive trials solutions

ICON offers a range of services to help achieve the best possible adaptive trial. These solutions includes the analysis and review of adaptive trial strategies across a portfolio of development products and the provision of oversight for ongoing adaptive trials.

Adaptive trials services