How Can Clinical Trial Development Be Accelerated?
The clinical trials process has come under increasing scrutiny as increased costs, long timelines and perceived inflexibility have stymied clinical development and led to re-allocation of clinical trial programs to more open regions. This has led to a push for modern innovative approaches that could expedite the trial process and also ensure treatments can reach underserved populations.
In this webinar, Ronan Fitzpatrick, Lead Statistician at nQuery, will provide an overview of the clinical trials landscape with a particular focus on areas such as Bayesian Statistics and seamless designs, which we expect will see significant regulatory developments in 2026 and how these will affect clinical trial design in 2026 and beyond.
Learning objective of this webinar:
The clinical trials process has come under increasing scrutiny as increased costs, long timelines and perceived inflexibility have stymied clinical development and led to re-allocation of clinical trial programs to more open regions. This has led to a push for modern innovative approaches that could expedite the trial process and also ensure treatments can reach underserved populations.
Major regulatory milestones such as the recent publication of the draft FDA Guidance “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products“ and draft “ICH E20 Adaptive Designs in Clinical Trials” show a clear path for innovation in clinical trial design which connects with high current interest in accelerated approvals, continuous trials and plausible mechanism pathways.
Whether it’s Bayesian statistics, seamless trials, AI/ML or external control arms, there is a clear interest in re-evaluating every aspect of clinical trial development to solve the practical issues that prevent innovative treatments reaching patients in a timely fashion.
Four key areas are covered:
1. Overview of Recent Trends in Clinical Trial Design
We begin by examining the broader clinical development landscape:
- Rising operational complexity and cost pressures
- Globalization and regional re-allocation of programs
- Growth of adaptive designs
- Increasing reliance on data-driven decision-making
- Greater scrutiny of trial efficiency and patient burden
This context sets the stage for understanding why innovation is not just desirable—but necessary.
2. A New Era for Bayesian Statistics
Bayesian methods are gaining renewed attention due to their flexibility and efficiency in clinical development. The webinar explores:
- Core principles of Bayesian inference
- Borrowing external or historical data
- Dynamic updating of evidence during trials
- Applications in early-phase and confirmatory studies
- Regulatory considerations and recent draft guidance
With clearer regulatory pathways emerging, Bayesian approaches may become central to modern development programs.
3. The Potential for Seamless and Continuous Trials
Seamless designs aim to reduce inefficiencies between traditional development phases. Key areas discussed include:
- Phase I/II and Phase II/III seamless designs
- Operational efficiencies from continuous development programs
- Reducing downtime between phases
- Adaptive decision-making within unified protocols
- Statistical considerations and Type I error control
These approaches can shorten timelines while maintaining statistical integrity.
4. Other Emerging Areas of Interest
Beyond Bayesian and seamless designs, the webinar also touches on:
- External control arms
- AI and machine learning in trial planning
- Real-world evidence integration
- Accelerated approval pathways
- Mechanism-based development strategies
Each of these tools contributes to a broader shift toward more flexible, data-efficient clinical development.
About nQuery
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It is an end-to-end platform covering Frequentist, Bayesian, and Adaptive designs with 1000+ sample size procedures.
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