Adaptive clinical trials can reduce time-to-market and cut development costs
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:
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.Download the whitepaper
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.Download the whitepaper
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.Download the whitepaper
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.
Read the whitepaper
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.
Over the past few years, regulators (FDA, EMA & PMDA) have provided guidance on the use of adaptive design for clinical development.
How can you strategically apply MCP-Mod in adaptive analysis to streamline your trial?
Teams at the forefront of adative design are looking to technological breakthroughs, for example by applying quantum computing to machine learning models to predict clincial trial outcomes. Such initiiatives will redefine how sponsors use data and adaptive design, ushering in a new era of clinical trials.
The different types of adaptive trial designs that have been deployed in oncology trials to good effect, and discusses how they have changed the development paradigm.
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