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Adaptive Trial Designs
Cytel has pioneered many of the most commonly used adaptive clinical trial designs and has extensive experience designing clinical development plans, helping you and your team learn from emerging data and pivot quickly to amend or adapt.
Unlocking the Power of Adaptive Clinical Trial Designs
Adaptive clinical trial designs allow you to make pre-specified modifications to trial protocol based on accumulating data. These designs offer you several advantages over traditional clinical trial designs, including increased efficiency, reduced cost, and greater flexibility. Each type of adaptive design has its strengths and weaknesses, and the choice of design depends on the specific research question and the available resources.
At Cytel, our trial designs are supported by detailed simulation and our consultants have considerable experience interacting successfully with regulatory agencies.
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Benefits of Adaptive Trial Designs
Adaptive designs can solve issues associated with traditional clinical trials.
Strategic benefits
Adaptive designs allow you to take interim looks while the trial is progressing. With this flow of information from throughout the trial, rather than just one result at the end, there is often an early “off-ramp” for cost and time in the form of stopping early for futility. By adapting the design to the accumulating data, the design has the best chance of success as it mitigates the risk of the trial failing.
Financial benefits
Predicting pitfalls is a major hurdle as you plan a clinical development program. The failure to predict accurately has led to concerning trial completion and success rates. Adaptive designs turn this uncertainty into an asset by incorporating flexibility into a trial, enabling you to take advantage of promising results midway through a trial. Strategies like constraining or increasing sample size, changing the dosage, and other modifications, help preserve your trial’s validity, mitigate risks, and optimize resources.
Ethical benefits
Adaptive designs enable you to stop a trial early if there are signs that a candidate drug or therapeutic is not effective, reducing patient exposure. Patient prospects might improve in some adaptive settings, particularly if enrolled after an interim analysis.
Adaptive trials can provide additional ethical benefits to patients and members of other vulnerable populations. In rare disease trials, the population sample is sometimes considered too small to justify market investment. The efficiency of certain adaptive designs (e.g. combined-phase designs or sample size re-estimation trials) can result in better sample size use and speedier trials without sacrificing statistical rigor.
Through simulations and forecasts performed by Cytel biostatisticians, adaptive trials can increase the probability of getting your therapy approved and bring new, potentially life-saving medicines to market more quickly.
Discover the benefits of Adaptive Trial Designs in our eBookBenefits of Adaptive Trial Designs
Adaptive designs can solve issues associated with traditional clinical trials.
Strategic benefits
Adaptive designs allow you to take interim looks while the trial is progressing. With this flow of information from throughout the trial, rather than just one result at the end, there is often an early “off-ramp” for cost and time in the form of stopping early for futility. By adapting the design to the accumulating data, the design has the best chance of success as it mitigates the risk of the trial failing.
Financial benefits
Predicting pitfalls is a major hurdle as you plan a clinical development program. The failure to predict accurately has led to concerning trial completion and success rates. Adaptive designs turn this uncertainty into an asset by incorporating flexibility into a trial, enabling you to take advantage of promising results midway through a trial. Strategies like constraining or increasing sample size, changing the dosage, and other modifications, help preserve your trial’s validity, mitigate risks, and optimize resources.
Ethical benefits
Adaptive designs enable you to stop a trial early if there are signs that a candidate drug or therapeutic is not effective, reducing patient exposure. Patient prospects might improve in some adaptive settings, particularly if enrolled after an interim analysis.
Adaptive trials can provide additional ethical benefits to patients and members of other vulnerable populations. In rare disease trials, the population sample is sometimes considered too small to justify market investment. The efficiency of certain adaptive designs (e.g. combined-phase designs or sample size re-estimation trials) can result in better sample size use and speedier trials without sacrificing statistical rigor.
Through simulations and forecasts performed by Cytel biostatisticians, adaptive trials can increase the probability of getting your therapy approved and bring new, potentially life-saving medicines to market more quickly.
Innovative Clinical Trial Design and Analysis
Innovative adaptive clinical trial designs can enable you to optimize the speed, savings, and probability of success of your clinical trials. Cytel’s statistical consultants and data managers work in tandem with your team to ensure new medicines move forward with the right study design. Our customer success stories in complex innovative clinical trial design span statistical trial design, regulatory submission, and the execution of advanced innovative trials, with several FDA and EMA approvals.
Adaptive Bayesian Methods
Bayesian methods are a form of statistical analysis where a hypothesis called a prior is systematically updated as more data comes in. This makes Bayesian methods ideal for small sample trials, clinical trials using historical data and real-world solutions, or clinical trials that require flexible learning. These computationally intensive statistical methods were once only accessible to a select few. For over a decade, statisticians at Cytel have been committed to ensuring that clinical solutions requiring Bayesian statistics are made accessible to all who need them.
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Testimonials
“Adaptive Bayesian techniques are the most natural way of including historical and in-trial data to inform and adapt the course of the trial and provide a more intuitive interpretation of the results. Adaptive trials use Bayesian techniques because they enable considered in-trial changes.”
J. Kyle Wathen
VP of Scientific Strategy and Innovation
Software for Trial Design and Simulation
East Horizon™ Platform
East Horizon™ merges East® and Solara® into a unified platform with R integration for advanced capabilities.
East Horizon’s comprehensive modules enable adaptive monitoring and a range of adaptive design options, including Phase II/III seamless designs, group sequential designs, multi-arm multi-stage designs, sample size re-estimation, population enrichment, adaptive dose-finding, and more.
Learn MoreAdaptive Trial Design eBook
Our Adaptive Trial Design eBook outlines common adaptive trial designs and their benefits, explores how to optimize your adaptive trial, and gives a ten-point framework to determine if your trial should be adaptive.
Download our eBook
100%
Regulatory acceptance of all adaptive clinical trial proposals.
20%
Reduction in trial duration with our adaptive trial designs
30%
Reduction in drug development costs with our adaptive trial designs
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