Clinical Trial Design Trends for 2025
Improving Trial Coverage and Complex Trial Designs
Innovation in clinical trial design is accelerating in response to the need to reduce drug development costs and ensure trials provide the right therapeutics to the right patients as efficiently as possible while maintaining trial integrity. Legislative and regulatory changes have created an environment more responsive to trial innovations and unmet patient needs.
In 2025, there should be continued growth in the use of complex trial elements such as adaptive design and Bayesian analysis and an increasing emphasis on improving the coverage of trials in areas such as rare diseases, paediatrics and trial diversity.
Adaptive design continues to grow at each stage of the clinical trial process. We project how adaptive design will grow and change in the upcoming year and what the upcoming ICH E20 on Adaptive Design will look like.
Bayesian analysis is widely used in early-phase clinical trials but less common in Phase III confirmatory trials. We break down the latest developments in early-phase trials while previewing the impact of the FDA’s upcoming draft guidance on Bayesian Clinical Trials on increasing the usage of Bayesian analysis at the confirmatory trial stage.
We also cover the latest trends and regulatory developments regarding methodological developments that could encourage more trials for rare diseases and pediatric populations, technological changes to improve the diversity of clinical trials and the implications of the continuing growth of the global (MRCT) trials.
This free tutorial provides an overview of these developments and the major regulatory guidances expected in 2025.
Learn about the latest developments in:
About nQuery
nQuery helps make your clinical trials faster, less costly and more successful. It is an end-to-end platform covering Frequentist, Bayesian, and Adaptive designs with 1000+ sample size procedures. Start your unlimited 14-day trial.
