So, you want to run a decentralised clinical trial...

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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.

 


 

The Key to Success in One Word: Flexibility

Notwithstanding all of the many benefits of a DCT model, it is likely that most DCT trials of the future will not be conducted 100% virtually, but rather will incorporate various DCT aspects, to one degree or another. Such a hybrid approach is often necessary due to:

Patient preference: Patients may prefer to see the investigator in person, face-to-face for at least some of their visits
Protocol necessity: Patients may need to be seen on-site in certain instances for drug administration, assessments, or procedures that cannot be performed remotely
Regulatory requirements: Varying regulations among participating countries may prohibit the use of certain DCT aspects
Medical necessity: The need to see a patient at the site may change based on the patient’s medical progress/deterioration
The type of investigational product: Not all types of investigational products are good candidates for direct-to-patient (DtP) shipment. Shipping drugs to patients may not be possible with controlled substances and with drugs requiring preparation or strict temperature adherence, among other criteria

Given these variables, the IRT system must, above all else, be flexible. Because DCTs often need to operate differently by geography (region, country, state), by site, and even by patient, the IRT must have the capability to adapt to different DCT components/systems involved, as well as to account for varying methodologies around drug assignments, shipments, and returns.

 


 

What Flexibility in an IRT Really Means

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This article is taken from International Clinical Trials November 2021, pages 87-89. © Samedan Ltd

 

 

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