The cost of clinical trials continues to rise as studies grow in complexity. A 2014 study by the Tufts Center for the Study of Drug Development found that it costs $2.6 billion on average to bring a drug to market in the U.S. In fact, there was a clinical trial for a rare hereditary metabolic disorder that enrolled only 4 patients and cost a total of $2.1 million.
The reason for the rising complexity (and corresponding costs) of randomized trials stems from a variety of factors that complicate supply management, including:
As clinical trials continue to grow in complexity, study managers need adaptive, unified technology to help reduce costs, streamlining study management, and maintain accurate, real-time study data. We’ll explore 7 ways a full-service Randomization and Trial Supply Management (RTSM) solution can maximize operational efficiencies for study managers and their teams.
A full-service RTSM should 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.
By unifying your RTSM with your EDC solution, you can better execute an adaptive response to trial management while enabling demand-driven stock and just-in-time supply workflows that reduce waste. Unified RTSM and EDC allow a two-in-one solution to save you time and money while ensuring your trial supply and randomization needs are met.
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. All of these scenarios directly impact your study budget and timeline.
A full-service RTSM offers the visibility study managers need to enable a demand-driven stock that reduces site overages by 20 – 40%. Go truly lean by aligning your sites’ storage capabilities with the trial’s randomization allocation and patient activity using pre-built, batch-management workflows that ensure only the approved IP is shipped and dispensed.
Enforced and integrated tracking logs immediately notify you of shipment receipt and automatic 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 can be 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.
It’s critical that study managers have complete visibility over their trial supply with full-service RTSM. Live tracking and temperature logs help guarantee IP integrity wasn’t compromised during shipment and storage so sites can confidently disperse to patients. If a drug’s temperature wasn’t properly maintained in transit, incident visibility makes it easy to identify when and where the issue occurred. An integrated RTSM across batch release, shipment approval, and expiry management help ensure that only approved IP is dispensed.
With immediate access to transit logs, approvals, and dispensation information, study managers can remove roadblocks that commonly impact IP availability and real-time decision-making. Build workflows that automatically release approval, quarantine, or replacement instructions so you can streamline study approvals and realize a truly lean supply chain.
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. Participant screening capabilities help capture demographic data and confirm eligibility criteria are met prior to your first randomization or treatment assignment. RTSM can aid 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.
To strengthen patient compliance during dispensing visits, study managers can send SMS messages reminding participants of their visit with visit-or-treatment-specific instructions. When dosing at home, treatment assignment and instruction on treatment allocated to each subject can be blinded or unblinded and include escalations or expansions such as single ascending dose (SAD) or multiple ascending doses (MAD).
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.
As mentioned above, RTSM’s power comes from connecting your clinical operations and data management teams onto 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. Generate live reports using enforced log and visit updates further reduce duplicate entry and reconciliation with an RTSM-EDC integration. 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 a seamless EDC integration, Medrio RTSM provides full visibility across the entire clinical trial lifecycle. Empower your teams to support any randomization schema, and implement demand-driven stock that reduces IP waste and produces better data. 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.
2 Thomas J. Moore; Hanzhe Zhang; Gerard Anderson; G. Caleb Alexander; Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016; Jama Intern Med; 24 September 20018