The increasing complexity of clinical study designs and unique treatment scenarios are making the randomization process for clinical trials more complicated.
In fact, a Tufts Center for the Study of Drug Development study found that the average clinical trial is collecting data on 86% more endpoints than the last decade.
In tandem, as sponsors strive to get their drugs to market faster—while navigating changing requirements and priorities—protocol complexity is increasing. This new paradigm is calling for larger study sizes with complex randomization schemes across a variety of therapeutic areas.
Not only do the trials need to support a growing number of treatment nuances, they must also support cohorts, titration, and changes to dosing. This is creating a greater need for tools that can navigate growing complexity and make the supply chain an integral part of clinical trial management.
RTSM is enabling sponsors and clinicians to manage complex protocols while shortening study timelines, controlling mid-study changes, and removing the need for source data reconciliation.
We will take a look at the ways a full-service RTSM solution can support complex randomization and benefit your supply chain operations, as well as participant management.
RTSM for Supply Chain Management
Full-service solutions like Medrio RTSM can enable clinical trial supply management from your manufacturer to the depot, and the trial site to the participant. It does this by tracking your inventory from its initial receipt until its eventual return and disposal.
The RTSM solution streamlines your supply chain by shortening system development time, supporting full-control over mid-study changes, and reducing the need for source data reconciliation so study managers can focus on more pressing needs—like patient recruitment.
RTSM helps study managers navigate trial complexity by tracking both depot and site inventory levels against current participant status and randomization assignment. As trials progress, the real-time inventory and participant data enable a demand-driven and adaptable supply chain algorithm that triggers pre-emptive reorder points.
Investigational product (IP) shipment receipts help automatically reconcile any disparities between the outer carton and inner carton contents. As shipments make their way from depot to depot, or to the study site, site staff can view real-time shipment receipts and even return shipments to the depot, as needed.
Alerts can also be configured for inventory warnings, subject visit warnings, late dispatch, and receipt of shipment. This granular level of detail is critical for streamline supply chain operations—especially for tracking a temperature excursion during shipment.
With help from a full-service RTSM, study managers can easily manage every step of their supply chain, regardless of complexity. Whether overseeing blinded/unblinded labeling, expiry, temperature management, or managing depot to depot shipments—Medrio RTSM can help each step of the way.
How RTSM Streamlines Participant Management
The benefits of RTSM expand far beyond supply management to benefit the participant experience. Easily capture demographic data and confirm eligibility criteria prior to randomization and treatment assignment with Medrio RTSM’s participant screening capabilities.
Regardless of the study size, demographics, or geographic location, RTSM empowers study managers to configure their study screening as needed. When Medrio RTSM is used with our powerful EDC, participants are immediately added into the RTSM module and available for screening. This allows study managers to configure their participant screening process in the following ways:
- Basic demographics including birthdate, age, date of informed consent, and other essential data points for randomization.
- Deeper demographics that are unique to your study, such as cohort-determining data that is more common as trial complexity increases.
- Single or multiple eligibility check questions that are necessary to confirm that inclusion and exclusion criteria are being met.
- Independent review and approval by a Medical Monitor before randomization assignment occurs.
The benefits of RTSM on your participant experience also extends to the dispensing visits. During the patient’s dispensing visit, RTSM accesses the dosing schedule and provides visit-specific instructions for every participant.
The treatment assignment and allocation instruction for each subject can be blinded and phased dosing plans can include expansions such as Single Ascending Dose (SAD) or Multiple Ascending Dose (MAD), depending on your need.
If the IP requires pre-dosing eligibility checks and configurable dose calculations for titrations, the RTSM can add to the study setup and refer to prior dispensing doses. In addition to dispensing information, Medrio RTSM captures visit data in real-time and syncs with our EDC for immediate documentation.
RTSM’s Role in Randomization & Treatment Assignments
Medrio RTSM supports a wide range of randomization types—from classic blocked and multiple treatment arms to complex stratification rules and cross-over designs.
We do this because we understand that complex randomization requires a flexible design. By offering a single solution for all randomization needs, Medrio RTSM can support everything from stratification to custom algorithms.
Whether blinded or open-label, participants will be assigned the appropriate treatment and sites will receive necessary instructions on treatment allocation for each participant at the dispensing site.
With just-in-time shipments based on site activity, study managers can also reduce supply overages and use automatic resupply orders to keep a steady stream of necessary IPs.
Sponsors can stay on top of randomization progress by opting to receive confirmation emails and reports. They can even review “dummy schedules” and approve them for participant allocation and assignment before the live schedule is used to allocate participants to the appropriate treatment arm or cohort.
Agile Solutions for Complex Randomization
Randomization can make or break your studies. The more the complexity of your study grows, the more clinical trials can fall victim to costly site overages. With Medrio’s single solution, you can reduce waste by as much as 40% while also increasing patient compliance.
Know which product is ready for dispensation within minutes of a product’s arrival on site thanks to our unique combination of enforced and integrated tracking solutions. And have peace of mind that as your studies grow in complexity, our full-service RTSM is ready to scale with you.