Justin Jaeschke, Vice President, Technology Solutions

Bryan Clayton, Vice President, Strategic Soultions

Next generation IRT continues to evolve from work horse to racehorse – with the power to keep pace with rising clinical trial complexity and efficiency demands.

Configuration, dynamic management and advanced supply management capabilities of IRT systems help clinical teams and clinical supply professionals do more with less.

Phase I solutions

Although Phase I requirements are narrower in scope than Phase II-III studies, the demands are often no less onerous. Early phase budgets often don’t support the same robustness and expense of system development that sponsors routinely use in later phase studies. Specialized IRT solutions for early phase studies are needed more than ever, especially with the rise of adaptive and other accelerated approaches.

Simplified, enterprise solutions for early phase studies need to be capable of managing:

  • Dynamic ability to add new cohorts as the trial expands
  • Multiple cohorts with different dosing strategies for each
  • Investigator selected cohorts or system randomization into cohorts
  • Patient replacement within a cohort
  • Drug management that supports global phase 1 studies

Configuration provides the ability to make changes after go-live without additional programming and validation. Configurability is not only beneficial for adaptive designs with open-ended protocols, it is especially valuable when protocol amendments introduce risk of timeline delays.

Configurable IRT systems allow the end user to update dose scheming from patient-to-patient and visit-to-visit. What’s more, this functionality is controlled by the end user, eliminating the need to get the IRT vendor involved or generate a change order.

Protocol amendments are the new normal, as is the need to support ever-expanding protocol complexity, and the ability to make changes quickly. In early phase drug development, time really is money, and speed is equally important as flexibility.

Drug Accountability and Returns

Drug reconciliation is part of every trial, but where it’s done is a matter of sponsor preference. It can be performed in an EDC, a clinical trial management system or even a site-specific solution, but the trend is moving to the IRT system, and for good reason. When drug reconciliation is part of your IRT system, sponsors gain complete visibility into the supply chain, with end-to-end management from drug release through reconciliation and destruction.

Why it Matters…

A built-in reconciliation module can literally save hundreds of hours of manual coordination across CRAs, depot representatives and clinical teams.

Novel Study Designs

As clinical trial complexity and cost continue to increase, so does demand for IRT functionality that supports novel designs, that allow for unprecedented efficiencies and the potential for accelerated development and approval. Platform, basket, and umbrella trials can find beneficial treatments with fewer patients, fewer patient failures, less time, and with greater probability of success than traditional two-arm approaches. These adaptive designs offer flexible features such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during a trial.

IRT functionality that supports these designs involves configurability, drug pooling strategies and supply management by program, for the ability to easily allocate supplies across multiple trials and to support multiple types of trials. Drug pooling offers benefits of simplified logistics and cost savings, among others.

Modular components of configurable systems can be quickly updated, based on the needs of the new protocol. Cycle time to go into production is much shorter because the modules are pre-validated.

Inspection Readiness

While increased regulatory scrutiny may be a trend we’ve seen for years, regulatory imperatives continue to focus on minimizing risks to data integrity and end-to-end transparency. Audit trails are the single most important component of a system to ensure data integrity to regulators. Evolving best practices and functionality to support regulatory assessment includes the ability to produce on-demand human readable audit trail reports, and data review practices that focus on active review and management vs. retrospective study reviews.

Regulatory considerations are frequently cited as the drivers behind new technology exploration, especially for more complete audit trail reporting and the ability to provide more data transparency.

Alignment with clinical supply management

Clinical supply management is often more art than science, as most data forecasts begin as estimates, and change constantly. However, managing the clinical supply chain becomes a lot more predictable when paired with an IRT system. Modern IRT systems connect supply and clinical teams to help find the best balance of both teams’ needs. These systems help clinical trials and supply management in several ways. IRT helps manage the randomization of patients and the dispensation of products to them to preserve unbiased results of the trial through predetermined patient demographics within the system. Inventory management is preprogrammed into the system based on the sponsor’s needs and provides the necessary visibility to manage supplies throughout the life of the trial.

When dispensing occurs, the system determines the correct drug/placebo and the dose based on the randomization list and site inventory. The system is also able to communicate with the site’s depot or distribution company regarding which drugs go to what sites and when those drugs are needed. For instance, if a patient visits the site once per week, the IRT will place orders for that patient’s dosage as needed based on pre-programmed criteria.

As each clinical trial is designed differently, an IRT system is designed to manage and meet the needs of a single, unique trial’s protocol. This includes how many patients are anticipated to be enrolled in the trial and when, and at which sites. In addition, this includes the type of drugs the trial will use, how frequently doses will be given, where the doses will be given, and which depots will be used, among a host of other criteria and variables that determine re-supply and streamline expiry management.

Future Directions

New IRT functionality will continue to evolve as advancing technologies offer new solutions to reduce time and cost in clinical research. Ahead, real-time data capabilities coupled with mobile health technologies will have increasing impact on clinical trial operations, enabling more patient-centric approaches and virtual trial designs. IRT will continue to support emerging research methodologies in this innovative biopharma landscape.   Look for innovations and additional support from YPrime as these trends take shape.