Integrated Design & Execution

Most simple adaptive designs, such as stopping for futility, do not require special technology and processes for trial execution. As the complexity of the adaptive trial and numbers of potential adaptations increase, specific technology and operational processes are necessary for efficient trial execution and to maintain trial integrity.

For these more sophisticated adaptive designs, ICON offers an integrated technology platform that combines EDC, randomization and drug supply management specifically for adaptive trials. Linked with the simulation and planning capabilities of ADDPLAN software, ICON is able to offer a truly integrated solution for designing and running adaptive clinical trials.

Our technologies, combined with more than a decade of experience designing, executing and managing adaptive clinical trials around the world, allow clients to maximize the benefits and avoid the pitfalls of adaptive design trials.

Adaptive monitoring

The FDA recognizes the challenges of monitoring clinical investigations, particularly complex adaptive clinical trials, and encourages the adoption of alternative monitoring solutions to ensure quality data collection and the safety of study subjects. (Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, August 2011)

ICON will develop and manage an appropriate, risk-based monitoring plan for an adaptive trial that customizes the level of source data verification (SDV) and the number of required site visits based on actual study results. Sponsors are able to potentially reduce the number of monitoring visits and study monitors to realize study efficiencies leading to significant cost-savings.

Adaptive SOPs

Ensuring that information is only made available to appropriate study participants is critical to maintain the integrity of an adaptive clinical trials. ICON has developed a comprehensive set of standard operating procedures (SOPs) for all of the processes associated with the design and execution of adaptive trials. These SOPs are embedded in our Quality Management System and address specific processes within biostatistics, data management, clinical operations and DMC management.

• Ability to get clean data quickly under tight, well-defined deadlines
• Ability to undertake automated statistical analysis
• Control of communication flow — for example separation/independence of the DMC from general trial activities
• Transmission of the recommendations of the DMC so as not to disclose subsequent changes to other members of the clinical trial team or Principal Investigators.