RTSM: Finding the right randomization & trial supply management system
One of the most crucial parts of running a clinical trial is managing randomization and drug supply levels. Ensuring that the right participants receive the right dosages of the right medication is essential to gathering accurate study results.
Though technology has simplified this process for researchers, understanding the various features of Randomization and Trial Supply Management (RTSM) systems is vital for finding the right fit for a study team. Read on to learn more about what these systems do, how they started, and what they can do to alleviate site burden.
What is RTSM?
Randomization and Trial Supply Management is an umbrella term that describes the technologies that allow study teams to enroll and randomize participants, in addition to managing orders of study drugs. RTSM systems include Interactive Voice Response Systems (IVRS), Interactive Web Response Systems (IWRS), and Interactive Response Technology (IRT).
Both IVRS and IWRS can be used for these features, and collectively, these systems are known as Interactive Response Technologies. IVRS is the older of the two types of systems, requiring users to follow phone prompts to enter their information. The updated version, IWRS, allows users to respond to prompts on a computer instead of a phone.
A history of RTSM systems
Before IRT systems were introduced, both trial randomization and supply ordering were done manually, which left more room for error in the process. In the 1990s, the first generation of RTSM systems was introduced with IVRS, with IWRS following in the early 2000s.
Since then, the systems have continually been improved, reducing the burden placed on the site staff and creating a more streamlined workflow. The systems of today include many out-of-the-box solutions for study teams to implement, while still offering customizable options that can be tailored to each trial.
How RTSM systems can help clinical trials
Streamlining site operations
One of the key benefits of an RTSM system is that it streamlines operations and increases the speed at which site staff can do their jobs. Many of these systems make use of common randomization algorithms so site teams do not have to start from scratch each time, but still have the option to make adjustments that fit the trial. Additionally, many companies now use Natural Language Processing (NLP), which allows sites to upload text describing the trial and have the randomization algorithm be programmed based on that information.
Reducing medication waste
Modern RTSM systems can also be a great asset due to how effectively they can reduce medication waste. Before these systems, the medication allocated for participants would have to be determined at the start of the trial, which meant that medication would be wasted if any participants dropped out. Today’s systems are able to automatically adjust order quantities to make changes in real-time, which ensures that medications are not wasted due to changes in participant numbers.
Managing trial supply
In addition to reducing waste, these management systems are also capable of spotting potential problems in study requirements, which can reduce supply issues. Most will also allow site staff to monitor the delivery of supplies and will alert them to any transit-related damages, which is especially crucial when temperature-controlled storage is required.
Though RTSM systems can alleviate many pain points when conducting a clinical trial, recruitment obstacles often persist and can lead to delays. If you’d like to learn how Antidote can help you find the right patients for your trial, get in touch today.