ICON offers the knowledge, software, systems and global footprint to make global adaptive trials a reality
Use of adaptive design has rapidly risen as sponsors capitalise on its ability to increase portfolio valuation by protecting good drugs from failure and improved decision-making at critical junctures in the development process.
ICON offers design, simulation and execution of adaptive clinical trials. We have:
- More than fifteen years of experience in successfully planning and managing adaptive clinical trials
- Experts with direct involvement in regulatory agency adoption of adaptive design trials and subsequent agency guidance
- Operational teams and technologies to apply the power of adaptive techniques to drug and medical device trials
20%of clinical trials in 2013 used an adaptive design
30-60%Potential cost savings
250+Adaptive clinical trials for over 30 sponsors globally
Our consulting teams help you achieve the best possible adaptive trial, including:
- Generation of the data sets required to demonstrate the value of an adaptive design trial over a conventional study
- Analysis and review of adaptive trial strategies across a portfolio of development products
- Insight into new design methodologies and statistical approaches and development of innovative trial methodologies
Design, simulation and execution of adaptive trials across all phases of development
Advice and guidance on the logistical and operational requirements for successful adaptive trial execution
- Oversight for ongoing adaptive trials to ensure that trial integrity and validity are maintained at all times
Customized training in adaptive trial statistical methodology
Regulatory agency discussions
For certain types of adaptive design trials it is advisable to meet and discuss the trial design with regulatory agencies. This is particularly true for confirmatory trials.
ICON has deep experience in helping Sponsor companies discuss their adaptive designs with regulatory agencies including pre-IND and end-of-phase II meetings with the FDA and scientific advice and protocol assistance meetings with the European authorities (EMA and national agencies).
Our global regulatory team, in conjunction with our adaptive design experts, provide comprehensive support covering all the requirements for agency meetings including:
- Preparation of a simulation report and statistical analysis plan covering the adaptive design
- Data review and preparation of draft questions
- Preparation and submission of the formal meeting request
- Preparation of the briefing book including finalization of questions
- Management of meeting logistics and meeting rehearsal
- Attendance and representation at the meeting
- Authorship and review of meeting minutes
ICON is the only CRO to offer a validated design, simulation and analysis software platform for adaptive clinical trials. This platform, ADDPLAN, is used by regulatory agencies around the world: FDA, EMA and PMDA, as well as over 50 pharmaceutical companies. Our experts are actively involved with the development of innovative statistical methodologies that serve to expand the repertoire of available adaptive designs. These methodologies are embedded into our ADDPLAN® software platform that helps clients overcome the logistical and operational hurdles to adaptive trial execution.
Adaptive trials insights
ICON's experts in adaptive trials designs contribute regularly to media and industry conversations in addition to the production of thought leadership content in the form of whitepapers and blogs.Adaptive trials insights
To learn more or to speak with an expert, contact us today.Contact us