New Release of FACTS Enhancing Trial Simulation

Understanding Clinical Trial Simulation

Clinical trial simulation represents a paradigm shift in the approach to designing clinical trials, particularly with the development of advanced software like FACTS (Fixed and Adaptive Clinical Trial Simulator) by Berry Consultants. This tool offers researchers the flexibility to test and refine clinical trial designs through simulation, bypassing the restrictions of traditional power calculations. FACTS allows for the exploration of complex adaptive trial designs—often uncharted territory inaccessible through conventional means. By simulating designs across various scenarios, researchers can find designs that enhance trial power, achieve answers more efficiently, and tailor trials to their unique research demands.

Historically, clinical trials relied on static, pencil-and-paper calculations. However, as trials have become more complex—incorporating multi-stage and adaptive designs—traditional methods fell short. FACTS addresses this challenge by enabling statistical simulations that can include dynamic adjustments and unique trial requirements. It operates as an invaluable tool, much like a flight simulator for trial designs, offering a sandbox to pressure test designs, explore adaptive techniques, and gain insights unobtainable by analytical calculations alone.

Over 16 years, FACTS has evolved from early simulators like the one created for the ASTIN Stroke Trial to its current and sophisticated form, FACTS 7.1. This development history highlights Berry Consultants’ long-term commitment to innovation, responding to increasing complexities in trial design with a tool that serves both in-house and external users in various research settings.

Major Enhancements in FACTS 7.1

The 7.1 version brings significant improvements, focusing on two key areas: open enrollment dose escalation and expanded quantities of interest —both critical in refining trial design.

Open Enrollment Dose Escalation: Traditionally, phase I trials progressed through sequential, cohort-based designs, often causing delays. FACTS 7.1 introduces greater flexibility by removing the cohort constraint, enabling continuous participant recruitment even before the previous cohort results are available. This potent flexibility reduces time consumption and boosts efficiency. Users benefit from enhanced, clear guidelines that steer the application of this methodology, fostering safer and more efficient trial approaches.

Bayesian Predictive Probabilities and Conditional Power: FACTS 7.1 equips users with robust capabilities for predicting the probability of trial success during its course. Predictive probabilities rely on Bayesian analysis, using existing accrued data to forecast potential outcomes. Researchers can make critical, data-driven decisions, such as halting enrollment when a success likelihood dips below or above specified thresholds. Such predictive functionality maximizes resource allocation, effectively curbing unnecessary expenses and timelines.

Moreover, the update improves simulation of multi-stage designs, allowing for high adaptability across or within phases, enabling flexible phase transitions and designs.

Future Directions and Improvements

Berry Consultants continuously strives for greater innovation through parallel development projects, enhancing both the functionality and user-friendliness of FACTS:

Ordinal Endpoints: The upcoming inclusion of ordinal endpoints—metrics on an ordered scale—will enable seamless simulation and analysis of trials dealing with scaled outcomes. This feature allows exploring Bayesian and frequentist methods and is anticipated for release in the near future.

Expanded Decision Criteria: Expanding the decision criteria will empower users to incorporate a broader spectrum of trial variables into decision models. Aspects like arm count, recruitment numbers, and elapsed trial duration can now be integrated, allowing for highly nuanced designs and decision-making specification.

Ease of Use Enhancements: Recognizing the existing learning curve, Berry Consultants are simplifying the user experience. Proposed improvements include intuitive Design Wizards, designed to streamline complex design setup, aligning with traditional templates yet allowing detailed customization. These tools promise to make FACTS more accessible while preserving the power and flexibility that users expect.

These developments will eventually transform FACTS from a powerful toolbox to an intuitive "aircraft carrier," offering pre-assembled options alongside the ability to customize bespoke trials. This dual capability aims to support both traditional and groundbreaking design exploration.

Anticipated Developments and User Empowerment

FACTS' forward trajectory is marked by continuous enhancements, ensuring users can effectively navigate an ever-expanding clinical landscape. These improvements are expected to empower users by providing:

Advanced Simulation Control: Users can expect enriched functionality, offering improved outputs and decision-making flexibility. This includes visual comparisons across multiple designs via integration with tools like Airship, facilitating a comprehensive understanding of varied trial outcomes.

Engagement with Novel Platforms: FACTS' compatibility with external software, such as the R programming language, opens pathways for customized data visualization and comparison, enhancing the trial simulation experience. This integration allows researchers to tailor outputs comprehensively to their audience and research objectives.

By enhancing applicability and cultivating simplicity in high-powered trial simulations, Berry Consultants sets a course for future scientific advancements. FACTS stands as a pivotal tool for clinical researchers, enabling profound explorations into trial design while balancing innovation and ease of use.

Conclusion

FACTS 7.1 exemplifies Berry Consultants' effort to transform clinical trial design through robust trial simulation capabilities. Its continuous development and broad feature set provide unprecedented flexibility, depth, and speed, empowering researchers to refine designs and optimize outcomes. As FACTS expands with future features and usability enhancements, it remains an indispensable asset in advancing clinical trial precision and effectiveness.