Modernizing clinical trials: the role and significance of RTSM

Wissam Kazan | June 20, 2024

Clinical research and therapeutic development are moving forward at a lightning fast pace. Among the many advancements, randomization and trial supply management (RTSM) stands out as a critical innovation, fundamentally reshaping how clinical trials are designed, executed, and managed globally.

RTSM represents an evolution from interactive response technology (IRT), which focused mainly on randomization and drug availability onsite. RTSM expands on IRT by integrating supply management, helping to connect clinical operations with supply chain activities.

Specifically, RTSM technology integrates two key aspects of clinical trials: the randomization of participants into different study arms and the management of the investigational or experimental product supply. This dual functionality ensures that trials follow protocol and that the correct investigational medicinal product gets to the right patient, in the right cohort, at the right time. Enhanced data integrity and a streamlined process accelerate the pace of clinical research.

Previously in clinical trial software, there was limited or no flexibility available to optimize drug supply management. Drugs are expensive and have prerequisites for maintenance so that they can be safely dispensed to a patient. Thus, the conventional methods of relying on manual processes to regulate supply management were far from optimal, leading to drug expiration and driving study costs up.

Given that an average study spans 35 sites and lasts three years, managing the drug supply based on subject participation and regionality of the sites can get complex very quickly. With Oracle Clinical One RTSM, supply management can be configured to balance supply delivery with demand as per local and regional requirements.

For example, in a global study, each region might have a different regulatory requirement about the shelf life of a drug being dispensed to a subject. In the past, this was either done manually or required specific programming in the RTSM system to enable that functionality. With Oracle Clinical One, this can be done in a simple and intuitive experience, at the right regional granularity. This optimization in drug supply and management can be calibrated at the study level, country level, and/or site level, maximizing the resources at hand.

Why is RTSM needed?

The essence of RTSM lies in its ability to uphold the integrity of onsite, decentralized, and hybrid clinical trials through unbiased randomization of participants. This ensures that the study results are reliable and free from allocation bias, a cornerstone in clinical research that underpins regulatory approvals and the eventual success of new therapies. As hybrid and decentralized clinical trials become more prevalent, and as there's a pressing need to encompass diverse global populations, it's essential to develop protocols that are friendly to patients and considerate of their daily routines. RTSM algorithms and needs are getting more nuanced, with an emerging need to focus on balancing groups, minimizing predictability (and thus selection bias), and enabling adaptive and flexible designs.

Moreover, flexible and adaptable supply management capabilities reduce drug waste, help ensure the timely delivery of medication to participants, and adjust to the real-time demands of the trial. This not only cuts overall costs but also enhances trial outcomes. With clinical trials increasingly globally, effective supply management is becoming table stakes, and RTSM systems need to provide the capabilities to adapt to regionally specific supply management needs.

Oracle’s global RTSM solution

At Oracle, our world-class product managers and software engineers have been heads down developing our RTSM solution, which is designed to be both comprehensive and interoperable, helping customers launch their trials swiftly, reliably, and securely. Our latest updates enhance usability and adaptability to regional and global requirements. Users can now efficiently navigate dynamic, country-specific regulations and requirements, achieving faster, more reliable, and transparent trial processes from start to finish.

Historically, RTSM solutions have been custom builds and code, which means that they take months to develop. Oracle’s RTSM reduces setup times for complex global studies from months to days. For example, Joel Harris, study sponsor from medical equipment manufacturer WallabyPhenox, says Oracle’s RTSM solution was key to them receiving FDA clearance: “Without Oracle, we would not have met our timelines […] The solution was quickly configured to handle our uniquely complex randomization and stratification requirements.”

The recent updates to Oracle RTSM include:

  • Automate Creation of Randomization List: Users can generate a randomization list based on study design to support production through regulatory reporting with on-demand regeneration.
  • Modify Do Not Dispense (DND) Exceptions: Enable modifications in the distribution settings to meet regional requirements easily and without a change order.
  • Design Reconciliation Form: Customized forms for reconciliation and trial supplies return processes.
  • Disallow Future Date (Rapid Build): Quick design feature for defining date fields. There is no need to write custom rules to alert end users when they have entered a future date. It’s now a click of a button.
  • Create Rules with Operational Data: Maximizing the built-in query management system, operational site, and subject data is now exposed to write rules. This helps to increase trial efficiency and makes it easier to reduce the burden on trial and sponsor users.

Wissam Kazan is an Oracle Vice President of Product and Engineering for Clinical Research. For more information about Oracle RTSM and Oracle’s other clinical research solutions, visit our website or read the press release. Stay tuned for regular updates.