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So, you want to run a decentralised clinical trial…

Interactive response technology is proving essential to the clinical trial industry, keeping up with eClinical trends in a variety of traditional and modern trial designs.

Authored by Almac Clinical Technology experts Mike Hutton, Head of Strategic Partnerships and Alliances, Ivan Hanley, Strategic Account Manager, and Matthew Lowrie, Quality Assurance Manager.

With the pandemic having catapulted decentralised clinical trials (DCTs) from a pipedream to a reality, it’s time to think carefully about what’s actually involved – particularly as it relates to the interactive response technology (IRT) system supporting virtual and hybrid trials. When contemplating a trial to be conducted virtually, either in its entirety or in part, sponsors should be aware of all the implications for the IRT and how it will randomise patients, raise drug shipments, and track drug assignment, dispensing, and returns. A new set of processes, communication pathways, and safeguards must be in place to ensure patient safety, data integrity, and regulatory compliance, not to mention smooth and efficient operations.

The IRT functions required to support DCT elements should be fully discussed and carefully considered as the protocol is being developed. While much is possible with a sophisticated and flexible IRT system, not everything that’s possible is advisable in a given situation. It’s important to be able to distinguish functionality that’s essential from what is only nice to have or even what may add unnecessary complexity.

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