Tackling complex trial designs in RTSM with advanced configuration

As drug development increasingly focuses on chronic, difficult-to-treat or rare diseases in more narrowly defined patient subpopulations, clinical trial designers are obliged to resort to more complex trial designs to measure the safety and efficacy of investigational drugs. However, traditional RTSM (randomization and trial supply management) systems are struggling to keep up.

The challenge is that during RTSM implementation for a specific trial, each possible patient journey path has to be considered, requiring RTSM systems to support a vast spectrum of design choices. At the same time, RTSM implementation often occurs under substantial time constraints. Traditional RTSM systems are either particularly good at supporting a wide variety of design choices or at completing study-specific implementation in a short time, but not both. Systems supporting or even relying on custom programming (bespoke systems) support more design choices, but often have long implementation lead times. By contrast, systems which rely more heavily on configuration are limited in the design choices they support, but take less time to implement.

Prancer RTSM^®  can do both. By using an advanced configuration approach in combination with natural language processing Prancer RTSM^® can support even the most complex patient journeys without the need for custom programming, leading to some of the shortest implementation timelines in the industry.

Advanced configuration is a study-specific implementation strategy which replaces the traditional configuration method of relying on a fixed set of choices with a much more flexible design approach. In advanced configuration, multiple treatment schedules of patient visits can be defined in the RTSM specification, with each visit consisting of any number of transactions. Each transaction is defined from a versatile transaction toolbox and can be further adapted to the required design with parameters and conditions, which are defined as logical statements that read directly from the RTSM database. The resulting vast quantity of possible advanced configurations allows Prancer RTSM^® to support virtually any clinical trial design.

Natural language processing is used In Prancer RTSM^® to interpret RTSM specifications into a functioning software implementation without the need for custom programming, which allows RTSM implementations to be completed in much shorter time frames than traditional bespoke RTSM systems. In addition, natural language processing allows users to work with fully functional sandbox versions of the RTSM user interface which evolve as the RTSM specification becomes more refined, thus facilitating true WYSIWYG (what you see is what you get) assessment of the RTSM implementation before specification sign-off.

Prancer RTSM® leverages innovative study implementation technology to combine supporting even the most complex trial designs with some of the lowest implementation durations in the industry.