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RTSM: Randomization & IRT for Clinical Trials

January 10, 2024

As clinical trials get increasingly complicated, biopharmaceutical firms search for clinical trial technology solutions to cut costs, streamline study management, and keep study information up-to-date. Technology has advanced in managing how rapidly a trial may begin, how quickly it is done, and how soon it is completed.

Randomization and Trial Supply Management (RTSM) refers to a significant clinical trial technology solution that is critical to the performance of a clinical study.

Despite the fact that the original technology was produced decades ago, Octalsoft has been driving innovation and advancements that enable organizations to keep up with the rising complexity of study design. Large, complicated, blinded worldwide trials that span many continents and enroll tens of thousands of patients under the supervision of a central site are increasingly viable.

RTSM in Clinical Trials

An RTSM system’s IWRS randomization technology regulates patient randomization effectively and precisely; automates Investigational Product (IP) supply and resupply to depots, locations, and direct-to-patient; and handles medication dosage and dispensing. 

The automation of supply and logistics management has enabled studies to involve a larger and more diversified range of patients from across the world. Modern systems may be swiftly set up and changed as needed. This automation can cut the trial period by weeks, saving money and allowing medicines to reach the market sooner.

Complex studies nowadays need RTSM systems to go beyond the essential functions of randomization, unblinding, and supply management and include sophisticated features such as:

  • Support for a variety of randomization schemes; Re-randomization:
  1. Treatments are assigned in predetermined ratios across several stratification or balancing parameters (e.g., sex, age groups, disease severity)
  2. Enrollment and administration of cohorts, both sequential and simultaneous; Patient Substitution
  3. Calculating complicated patient dosage allocations accurately
  4. Responsibility in Supply
  5. Direct-to-patient shipment with the option of dispensing from site stock or straight from the depot.
  6. To ensure that locations do not run out of stocks, IP replenishment is automated and adjustable.
  7. Monitoring recruiting, supply availability, and forecasting in real time; adjusting replenishment parameters
  8. Exporting features that allow study data retrieval dependent on the user's blinded state (historical supply and shipments, dose assignments, and patient status)
  • Patient Randomization

Randomization in clinical trials guarantees that participants are allocated to treatment groups at random in order to reduce predictability and bias. 

Randomization's primary goal is to ensure comparability between the intervention and control groups in order to explain variations in findings or outcomes by treatment, hence assuring statistical power. While accuracy and efficiency are critical, it is vital to remember that patient allocation to treatment arms is only one aspect of what an RTSM can achieve in a clinical trial.

  • Trial Supply Management
  1. To ensure that sufficient quantities of the right product are on-site at the right times, 
  2. To minimize waste and 
  3. To increase efficiency by leveraging computer processing for mundane, logical tasks—all while keeping the treatment blind and supporting patient safety.

In the past, exploratory medication kits in clinical research were frequently branded with the patient's randomization ID and included all of the medicines required for the length of the trial. Large volumes of experimental product may be squandered if the patient was not enrolled or if their participation was terminated prematurely. 

Early RTSM solutions helped save waste by storing just what was likely to be needed in the near future on-site and automatically requesting extra IP for the site depending on the patient's treatment arm and visit schedule. Since RTSM could tell the trial coordinator or pharmacist which kit to administer at each visit, blinded, uniquely identified site inventory was no longer required to be pre-allocated to patients.

Modern RTSM enables end users with study expertise and understanding to configure multiple supply plans for different site profiles and types of inventory; to set alerts for risk conditions such as low depot supply, shipments that have not been received within a reasonable timeframe, and upcoming expiry; and even to project and output a site's or study's future inventory needs over time to better schedule manufacturing and labeling efforts. 

Supplies that are used in many studies can be pooled at both the depot and the site level to maximize inventory flexibility. Direct data sharing between RTSM and third-party inventory management systems eliminates human work while improving efficiency and data quality.

With the growing availability of these strong capabilities, it is becoming increasingly customary to employ current RTSM to handle not just serialized (numbered) inventory but also bulk (unnumbered) investigative and supplementary supplies. RTSM can now provide supervision for the whole life-cycle of clinical supplies thanks to supply accountability, returns, and destruction features.

  • Protecting the Blind and Patient Safety

The maintenance of the blind is critical for preventing evaluation bias induced by knowledge about a specific patient's therapy. When compared to alternative approaches with a lower degree of control, the IWRS randomization automated code break feature provides stronger security and a superior audit trail (code break envelopes, 24-hour manned telephone line, etc.). 

The system is set up such that the investigator, a designated study leader, and/or a user from the global drug safety department may unblind the patient and check dose accuracy. The patient's safety is secured, and the study's integrity is maintained using this secure, robust technique combined with easily available access to patient therapy.

  • RTSM Expertise in Build and Execution

While negotiating possible hazards and research complexity, it is vital that the team creating the RTSM construct and supporting study execution has substantial industry expertise in the RTSM domain. 

This allows them to maximize both the deployment of enhanced functionality and the supply of services necessary to properly support the clinical trial. For example, complicated randomization systems nowadays sometimes need numerous stratum combinations but a limited number of patients. Others have a vast number of kit types and dosing regimens, which, when combined with geographically diversified site locations, makes it difficult to execute a study efficiently. 

In certain circumstances, enrolling and managing the whole logistics is almost impossible, putting a significant strain on study and site resources. Engaging specialists who have participated in complicated, diverse, and worldwide studies may assist research teams in developing effective methods, making decisions, and optimizing their outcomes.

In Summation

RTSM is an important clinical research management tool. Randomization enhances treatment-group balance and decreases selection bias in clinical research. Clinical trial supply management guarantees that the correct investigational drug or supplies are administered to the correct patient on time, every time. 

The use of experienced teams and sophisticated technology is the most effective strategy to maintain research integrity and assure patient safety. To meet expectations and accomplish desired results, all of these must be applied appropriately and consistently. Interested in finding out how Octalsoft’s RTSM can add value to your next clinical trial? Book a demo with us NOW!

Arun Janardhanan

Arun Janardhanan

This piece is co-authored by Nishan Raj, Senior Content Writer at Octalsoft.

Arun Janardhanan

This piece is co-authored by Nishan Raj, Senior Content Writer at Octalsoft.
Wherever there is the latest news, the newest culture shift, and the zaniest people, you are bound to find Mr. Arun Janardhanan, Senior Project Manager and Delivery Manager at Octalsoft. Arun discovered his love for technology early and quickly chose a career in IT. We at Octalsoft were lucky to scoop him up just in time before this jet setter zoomed off into the horizon. From ideating and innovating and on to managing executions of our products, critical to all strategic discussions, Arun is ever-present when it comes to developing new strategies, processes, structures, and organizational systems.

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