Author: Marc Weinberg, MBA, Senior Director of RTSM
The cost of clinical trials continues to rise as studies grow in complexity. In fact, a recent clinical trial for a rare hereditary metabolic disorder that enrolled only 4 patients reportedly cost a total of $2.1 million . The rising complexity (and corresponding costs) of randomized trials stems from a variety of factors that complicate supply management, including:
- Complex protocols
- Shorter timelines for patient enrollment
- Country-specific regulations
- Lack of historical data to create accurate forecasts
- Logistical challenges in transporting and distributing trial drugs and IP
- Cross-system alignment
In this article, we’ll explore how a full-service Randomization and Trial Supply Management (RTSM) solution, the next evolution of technologies like Interactive Response System (IRT), can maximize efficiencies for study managers and their teams.
A full-service RTSM should be able to serve as the single solution for all of your randomization and trial supply needs. From classic blocked to single stratified, covariate to responsive adaptive design—no two trial randomizations are the same. Study managers require an adaptive RTSM that can handle multiple study cohorts, randomization schema, dosing, and visit schedules.
Let an RTSM solution streamline complicated workflows in your supply chain to ensure your drug or IP is available at the right time and site for dispensation. With enhanced visibility from a full-service RTSM, study managers can access real-time study data and reports to stay on top of progress and enrollment efforts, decrease budget risk, fast-track approval decision-making, and reduce waste.
Each IP is subject to unique maintenance requirements during its journey from production to dispensation. Once it arrives, sites are tasked with receiving, storing, approving, or quarantining, and properly dispensing the IP. Without full visibility over the IP lifecycle, study managers can inadvertently overburden a site with excess inventory, resulting in a lack of storage space, inadequate storage conditions, or even accidental IP dispensation.
A full-service RTSM offers improved visibility. Enforced and integrated tracking logs immediately notify you of shipment receipt and the ability to automate resupply orders ensure your sites have enough of the right product available for study participants. This level of granular visibility, paired with real-time data sharing and dispensation modules, means your teams are ready in time for your first patient randomization.
Without a full-service RTSM, study supply managers are tasked with manually calculating supply, resupply, and shipment requests for their sites. On top of that, many randomized trials rely on a variety of systems that prevent real-time data sharing across dispersed sites, depots, and teams which further delays approvals.
A full-service RTSM removes the burden of manual supply management and streamlines study approvals. Managers can remove roadblocks that commonly impact IP availability and real-time decision-making. With immediate access to transit logs, approvals, and dispensation information, study supply managers can build workflows that automatically release approval, quarantine, or replacement instructions. At the same time, a full-service RTSM offers live tracking and temperature logs that help guarantee IP integrity wasn’t compromised during shipment and storage so sites can confidently disperse to patients. If there is a problem, incident visibility makes it easy to identify when and where the issue occurred.
Having a full-service RTSM helps capture demographic data and confirm eligibility criteria are met prior to your first randomization or treatment assignment. RTSM can help with dosing and dispensation, at the patient’s home or on-site. Pre-dosing eligibility checks and configurable dose calculations can be added to the study setup and implemented prior to dispensation to aid in treatment adherence. In addition to dispensing, full-service RTSM captures visit data including visit and withdrawal date. This information serves to facilitate a just-in-time supply chain, as well as strengthen patient adherence with clear instructions and timely updates.
Recruitment continues to plague study managers and is responsible for 80% of clinical trial delays . Especially in studies that require subjects with a specific disease or physiological characteristic, failing to recruit enough patients can lead to insufficient data. Yet, 11% of sites in a given trial fail to enroll a single patient . Full-service RTSM streamlines your study operations so trial managers can focus on more pressing needs—like patient recruitment and retention.
RTSM’s power comes from connecting your clinical operations and data management teams to a single system. A lack of seamless integration across your trial supply chain and disparate systems can result in reporting challenges or delayed decisions.
With a full-service RTSM, teams can share data across their facilities, sites, and clinical trial operators for real-time reports that improve data quality and reduce the reconciliation burden. With reports that are filterable, customizable, and always exportable—study managers can make data-driven decisions that keep their studies on track.
Full-service RTSM used to feel like an impossible feat. Study managers had to painstakingly choose between systems that support trial supply OR randomization needs. With Medrio RTSM, you can gain complete subject record management AND end-to-end supply chain functionality.
Medrio RTSM acts as the single solution for your randomization and operational requirements. With its seamless EDC integration, Medrio RTSM provides full visibility across the entire clinical trial lifecycle. And higher quality, real-time data across an integrated supply chain means you can save time and money by using fewer resources and less inventory while still ensuring the right product is available for every patient at the right time. Learn more about Medrio RTSM or request a demo to see how it works.
- Moore, T. J., Zhang, H., Anderson, G., & Alexander, G. C. (2018). Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA internal medicine, 178(11), 1451–1457.
- Kantor, E. (2022, Mar 26). 5 common clinical trial patient recruitment challenges and solutions. Antidote. Retrieved 28 Sep 2022