Early phase clinical trials share distinct challenges: constrained budgets, compressed timelines and operational complexity despite small study size. While the technology that manages randomization and trial supply management (RTSM) is commonplace in Phase II and III studies, it has traditionally been seen as too expensive or inflexible to address early phase study requirements.

What makes early phase trials different?

Phase I trials most often involve a small number of participants. Accordingly, budgets are low and study team members are hands on. Typically, this means that RTSM functions are managed manually with spreadsheets to avoid the time and costs associated with the set-up of an interactive response technology (IRT) system. Additionally, many Phase I studies are open-label, removing the need for blinding – a core function of IRT systems.

However, early phase studies are becoming more sophisticated. Therapeutic areas such as oncology, cell and gene therapy, and rare diseases require study teams to respond quickly to make adjustments to cohorts, treatment arms, visit schedules and dosages. Additionally, expanding to Phase I and keeping track of these variables in manual systems puts undue burden on study teams and increases the risk of errors.

Sponsors are now reconsidering the role of IRT in early phase trials, but not all technology providers can deliver the flexibility needed to address the demands. Here’s how IQVIA IRT is being deployed to bring greater control, ease-of-use, and cost efficiencies over manual processes.

Simplicity, transparency and control: Meeting the needs of Phase 1 trials

As the director of project management in IQVIA Technologies’ Delivery organization, I work with study teams at leading pharmaceutical companies every day. My role is to ensure they receive the white-glove service, support, and expertise they need to set up and operate an IRT system they can count on to maintain the integrity of their trials. As requests for early phase IRT implementations grow, my team is taking advantage of the flexibility and capabilities inherent in IQVIA IRT to meet their distinct requirements.

Meeting the design criteria

The solution we developed for Phase I study teams offers a novel method for managing the IRT system. Recognizing the urgency and budget limitations, we developed a flexible and robust solution that enables study teams to make real-time adjustments to a study design based on protocol and patient data. This eliminates the need for expensive and time-consuming customizations. Specific requirements requested by our clients include:

• Development of a configurable and rapidly deployable IRT system at go-live for early phase studies that reduces the need for customization
• Self-service tools for the management of early phase studies throughout the live study
• Self-service help information contextualized to the functionality being accessed

A key feature of the solution is the ability to activate and deactivate functions in real time, adapting to changing requirements throughout the study. To achieve this, we developed a range of adaptable features within a self-service framework. Using the intuitive and flexible tools of IQVIA IRT, study teams are able to:

• Manage cohorts, enabling the configuration, activation, deactivation and reactivation of cohorts during the live study
• Manage treatment arms, which can be activated, deactivated or reactivated as needed, and connected to active cohorts
• Add new visits during the course of the study
• Manage dose levels and update dispensing rules accordingly
• Add and update trial sites
• Add and update users

In addition, our early phase system provides self-service forms for patient management and drug supply support.

Patient management

• Patient allocation – IQVIA IRT Delivery can manage the full process, including initial allocation (with results and history available in real-time reports) and confirmation of informed consent and eligibility
• Molecular pre-screening for individual groups of patients, as well as screening results
• Enrollment/randomization for participants who have successfully screened and not screen-failed
• Capping and recruitment suspension

Drug supply management

• Local vs. global sourcing allows study treatments to be switched back and forth from local to global supply at pack-type level

A solution for all Phase I trials

IQVIA Technologies now offers this cost-effective IRT solution that can be rapidly deployed in virtually any early phase study, helping sponsors move away from manual processes and toward greater transparency and efficiency. With the ability to adjust cohorts, treatment arms, and visit schedules in real time, study teams gain the flexibility to adapt to trial demands.

Are you a sponsor that may benefit from this new approach to Phase I studies? Contact our experts today at www.iqvia.com/irt.