FLEX ADVANTAGE is ICON's proprietary Interactive Response Technology (IRT) platform for managing patient randomisation, investigator sites and clinical supplies specifically for adaptive trials. It is part of the ICONIK Informatics Hub.
Leading the way in Adaptive Design
ICON’s understanding of agency requirements, vast experience in adaptive trials, and ADDPLAN technoloogy, uniquely positions us in the industry as a top innovator in this field.
Unlike conventional trials, many adaptive randomisation schemes require recalculation of the treatment assignments probabilities during the trial's conduct. FLEX ADVANTAGE technology allows companies to support adaptive randomisation trials efficiently, while maintaining trial integrity throughout.
Regulatory agency concerns
Key concerns for regulatory agencies in adaptive trials include the protection, security, and safeguards against operational bias. Regulatory agencies need assurance that the sponsor, project team, patients, and principal investigators were appropriately firewalled from access to interim results. By implementing FLEX ADVANTAGE, ICON can satisfy those requirements and concerns. Additionally, we have well‑established workflow practices with SOPs reflecting the requirements of adaptive trials, as shown below.
Adaptive Trial technology & FDA guidance
There are a range of adaptive designs and statistical software design packages available to bring benefits in all the phases of clinical drug development. However, as noted in the FDA guidance document, maintaining the integrity of the trial by not introducing any operational bias and inadvertently breaking the blind are the key elements of the execution. This emphasises the need to ensure that the validity and integrity of the trial are maintained when using adaptive design:
Role based data access
Randomisation and drug supply are encrypted in the system so access to this data is limited and role-based. Therefore, FLEX ADVANTAGE is able to provide unblinded information to the appropriate people: