There is no denying that trial complexity is continuing to increase. Several factors in recent years have contributed to this rise including more complex trial designs, the rapid adoption of decentralisation stemming from the pandemic, and larger global trials.
Unplanned protocol deviations, which add time and cost to a study, are also contributors to complexity. According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial.1 Regardless of what the contributing factors are, these complexities add to the already challenging environment where budget, timeline, and productivity must be managed carefully.
Facing this more complex landscape, sponsors, CROs, and study professionals are seeking ways to gain more control to better manage the unexpected. Here, we examine three essential ways you can take advantage of the latest technology advancements to meet the challenges of complexity head-on and support a successful, smooth-running trial.
Demand planning drives trial efficiency
Managing drug supply in the midst of unexpected and changing circumstances can be overwhelming. When events such as under or over-enrollment occur or a protocol amendment is made, the ripple effects impact drug supply directly.
Underproduction and drug stockouts can result in patients not receiving scheduled doses. Beyond the negative impact this has on patient experience and treatment, this also leads to additional costs and timeline delays. To avoid this, many trial supply managers will overestimate the production of supplies. However, overproduction leads to subsequent wastage of drugs, which can be an even more costly problem that can dramatically increase trial expenses.
Responding to these variables is difficult to manage manually. It’s both time-consuming and risks human error. Staying on top of it is primarily a reactive exercise. So how can studies stay on top of their drug supply needs when in the midst of unknown variables?
Advanced analytical technologies, including AI and machine learning, are making forecasting and optimization more accurate and accessible to clinical trial managers. Further, integrating real-time IRT trial data into this system enables ongoing drug supply optimisation. To truly make this work, it is critical to have a flexible IRT system in place that can quickly adjust to trial supply needs.
In May, deeptech powerhouse N-SIDE and Suvoda, a leader in flexible IRT, announced their partnership to deliver advanced forecasting and optimization that has already yielded significant results for more than 100 clinical trials. By adopting an integrated demand planning strategy, trials have realised significant cost savings through reduced wastage and accelerated trial timelines.
“Our forecasting and optimization tools supplied with data from Suvoda’s IRT give clinical supply managers a unique opportunity to continuously monitor and optimise their supply chain throughout the life of the trial,” says Amaury Jeandrain, N-SIDE’s senior director of solutions engineering & partnerships. “Trial teams can make critical adjustments to drug supply in an ongoing trial through AI and the feed from the IRT’s real-time data.”
IRT standardisation leads to increased consistency and quality
Many sponsors and CROs conduct multiple trials simultaneously. With varying degrees of IRT experience on each team, these systems can become inconsistent across the organisation. Additionally, when setting up foundational elements of the system, teams within the same organisation are likely to be duplicating efforts, which is ultimately inefficient.
A standardised IRT foundation can be a consistent, reliable starting point for all studies within the organisation. By creating and implementing an IRT foundation, study teams are positioned to focus on protocol-specific elements of their individual trials. This avoids duplicating effort and reduces time spent on user acceptance testing (UAT) for the standard functionality.
Consistency is often the key to quality, and multinational pharmaceutical company, Bayer, can attest to this. The company has worked in partnership with its IRT vendor, Suvoda, to establish a core IRT based on their Bayer standards. The core system, known as “BAYSYS IRT”, is now a formally validated product that promotes consistency across trials and is expected to speed up the IRT system go-live for Bayer studies.
“Using our established IRT standards, we worked with Suvoda to program a core system that incorporated those standards and created a base from which all our IRT systems could be customised to specific protocol needs,” says Julia Redgate, IRT system and supplier manager at Bayer. “With the use of this base system, we’re expecting to improve quality and efficiency without sacrificing flexibility for individual studies.”
Seamless integration empowers data-driven decisions, fast
As the number of clinical trial technology solutions continues to increase to support today’s trials, it’s important to understand what integrating these vital resources can do for your studies. Integrations can often be fraught with their own complexities, but the right integrations can create a dependable ecosystem that supports team members at every level.
Despite the many benefits of integrating systems, there remains hesitancy by some. Data authenticity, integrity, and confidentiality has been cited as a barrier to integration, as well as management of data quality and the system’s reliability. There also remain perceptions of technology integration impeding trial timelines. However, with the programming found in modern systems, integration can be an easy way to cut down on manual work and reduce human error.
“Integrating systems can be instrumental in reducing errors and minimising data redundancy,” says Wilmer Barndt, Suvoda associate director of services delivery. “More importantly, it provides access to real-time clinical data that supports meaningful, mid-trial decision making.”
Solutions such as IRT, electronic consent (eConsent), and electronic clinical outcome assessment (eCOA) are all critical tools for supporting trials in today’s complex landscape. Sponsors often rely on integrating these point solutions to create a unified platform where individual systems seamlessly communicate and share data. When done right, this streamlines processes and ensures data is accurate and actionable in real time. For example, integrating eConsent or eCOA with IRT eliminates the risk of human error in recording consent forms or gathering time-sensitive COA information, as well as cuts down on these time-consuming tasks that, when missed, can result in data loss, trial delays, and a negative patient experience.
“Our platform leverages the latest technologies that allow us to deliver our seamless, patient-centric solutions more efficiently,” says E.K. Koh, Suvoda’s chief product officer. “We’re consistently focused on delivering a flexible and more integrated approach to our products that streamlines workflow and increases clinician and patient visibility over the life of the trial.”
As clinical trial complexity continues to grow, now is the time for trial professionals to look deeper at what modern technologies can do to alleviate their day-to-day challenges. Automating time-consuming, yet crucial tasks provide greater visibility and control over the supply chain and the patient journey. By making the most of technical solutions and vendor partnerships through effective forecasting, standardisation, and system integration, sponsors can build more efficient, patient-centered, and future-proofed trials. With streamlined, consistent processes and the reduction of staff workloads, studies gain more time to focus on what matters most: the patient.
1 Tufts Center for the Study of Drug Development (CSDD); Jan/Feb 2022 Impact Report