Fully Featured Yet Simplified Phase 1 IRT Solution
Traditional thinking was that Phase 1 clinical studies were small and simple, making randomization and clinical supply management technology too expensive and resource intensive for the size and scope of the study. However, with the growing trend towards personalized medicine and gene therapies, creative trial designs, expanded protocol complexity, and increasing number of protocol amendments throughout a trial, today’s Phase 1 clinical trials can be even more complex than Phase 2 or 3 trials.
The Challenge
A biopharmaceutical company had an early phase oncology study with an adaptive trial design and open-label enrollment. The protocol design allowed for study level dosing adjustment among every subject or cohort as needed, with the potential for more than ten dose changes over the study’s duration. The company wanted an IRT solution to help manage complex stratification, site activity management, and patient management. As a quality assurance imperative, the company had to replace their manual randomization efforts using spreadsheets with a validated system. It had to support the diverse requirements of the company’s multi-program Phase 1 studies and provide the ability to make changes after system go-live. However, they did not need the robust functionality or expense of an IRT system that supported Phase 2 or 3 studies.
With most traditional IRT systems, dispensing changes requires a major system interruption involving change orders, followed by programming, testing, validation and multiple review cycles, and span anywhere from two to eight weeks whenever a dose is switched. With the potential for any number of protocol amendments requiring a dispensing update, time lost due to change orders is not only staggering but highly impractical.
The YPrime Solution
YPrime’s fully featured yet simplified IRT enterprise solution allowed the sponsor to configure their randomization and supply parameters, giving them the ability to better manage dosing scenarios, visit schedules, and drug supply for complex oncology studies. YPrime’s early phase IRT solution maps each patient to a visit and study medication schedule and offers flexible clinical supplies management capabilities.
In addition, the sponsor’s clinical team maintains control over cohort management with YPrime’s functionality that includes:
- Name or re-name
- Open and close a cohort
- Change the number of patients allowed per cohort
- Replace patients within a cohort
- Manage investigator-selected or system-randomized cohorts
- Manage multiple cohorts with different dosing strategies for each
This cost-effective, configurable IRT platform replaces manual methods with a validated system and allows the study team to adjust dispensing levels within the system, without the need to enlist the helpdesk, project manager, or generate change orders. Paired with sound project management and a robust set of standards now allows the sponsor to implement Phase 1 studies in less than four weeks, collect data quickly, and provides them the ability to proceed directly to the next phase of development once the optimal dose is determined.
YPrime’s early phase IRT solution offers the most efficient path to your next milestone by removing unnecessary delays, cost, and complexity.
