Adaptive Trials: Product development strategies for the next decade.
Regulatory and resource pressures are driving the switch to adaptive clinical trials. Aptiv Solutions – with an unmatched array of global talent, the most advanced technology in the industry and real-world expertise – is leading the way in enabling drug and device development companies to fully understand this new land-scape, and take advantage of its possibilities.
- 850 Professionals, operating out of 26 offices
- More than 100 adaptive trials for over 30 sponsors in the last 10 years
- Locations in the USA, Switzerland, Austria, Czech Republic, France, Germany, Hungary, Italy, Israel, Netherlands, Poland, Russia, Spain, Ukraine, United Kingdom, Japan & Australia, with strategic partners in India, Asia & South America
Aptiv Solutions is the only CRO to combine proven design, simulation and execution capabilities for adaptive clinical trials.
An integrated suite of adaptive trials systems & processes
- Adaptive Trials Systems
- Adaptive Trials Processes:
- Independent Statistical Center (ISC) to handle unblended clinical data
- Adaptive trial SOPs, documentation and workflow processes
Understanding the road ahead.
An adaptive clinical trial uses accumulating data to decide how to modify aspects of the study as it continues, without undermining the validity and integrity of the trial.
Regulatory authorities in the US and Europe have published “Guidance Documents” on the use and implementation of adaptive design trials. These include definitions for “adaptive” that specify modifications of design elements, as well as important issues to consider before moving forward – such as assuring that your CRO has expertise and comprehensive SOPs for adaptive trials.
Adaptive Trials Benefits
- Get the right answer sooner
- Manage costs by controlling sample sizes
- Improve understanding of treatment effects
- Increase flexibility: change sample size or randomization, switch goals, drop or add treatment arms, etc.
- Ethical advantages: fewer “futile” studies, fewer patients on placebo
Challenges of Adaptive Trials
- Protection, security, safeguards against operational bias
- Timelines of data availability for interim analysis
- High manual overhead to manage workflow
- Workarounds for inflexible randomization systems
- Coordination with drug supply