Effective Use Of IRT In Decentralized And Hybrid Clinical Trials

By Jon Paras, YPrime

The increasingly complex protocols, disparate patient populations, and evolving needs of modern clinical trials have necessitated solutions geared toward simplifying, digitizing, and democratizing studies. Patient-centric trials, such as decentralized clinical trials (DCTs) and hybrid trials, have all emerged as potential answers to this complexity, owing to their flexibility when compared to traditional on-site studies. Yet despite the advantages of increasingly remote, technology-supported clinical trial models, there remain a number of hurdles to their widespread adoption. One of the central challenges to enabling these trial designs lies with the technologies developed to support trial logistics, drug distribution, and patient randomization.

Interactive Response Technology (IRT) is likely to play an increasingly significant role in addressing the complex challenges of drug management and distribution for decentralized and hybrid clinical trials. IRTs are designed to help trial sponsors manage the distribution of medications, forecast trial supply, and integrate workflows with other technology platforms. As the primary system for managing a trial’s patient randomization and clinical supplies, having an effective IRT can serve to simplify trial oversight and management. Establishing an IRT that allows for right-sized logistical management and secure patient oversight requires an understanding of the sponsor’s clinical protocol and defined business processes to develop the proper data integration and workflow optimizations necessary for trial success.