IRT Trends for Today and Tomorrow: Insights From a Survey of Clinical Research Executives
Interactive response technology (IRT) is the system that manages randomization, treatment assignment, and investigational product supply across a clinical trial. New to the term? Start with What Is IRT in Clinical Trials and Why Does It Matter?
IRT has been part of clinical research for about 30 years, and it touches nearly every milestone in a study, from first patient in to the last kit shipped. So we asked the people who run it what’s working and what isn’t.
In October 2023, YPrime surveyed 100 clinical research professionals. Every respondent works in pharma or biotech, holds a director-level role or above, and rates themselves as extremely or very familiar with IRT. They work across Phase 1, 2, and 3 studies in clinical operations, IRT development, R&D, and clinical trial management.
One theme came up in almost every question: time. Timelines and delays topped the list of trial-level concerns, then topped it again when we asked about IRT specifically. The data points to 2 places where that time goes: study startup and protocol amendments.
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What 100 clinical research leaders told us about delays, amendments, and choosing an IRT provider
Timelines and delays are the top concern in clinical trials
Asked to rank the 3 issues that keep them up at night when running a trial, 61% put timelines and delays in their top 3. Patient recruitment followed at 55%, then data quality (40%) and cost (39%). The two are linked: a slow-enrolling site pushes every downstream milestone, and IRT sits in the middle of that chain.
The biggest IRT issues: delays, flexibility, and vendor trust
On IRT specifically, 62% ranked timelines and delays in their top 3, and 38% ranked it first. No other issue came close to that first-place share. Lack of technology flexibility (41%), trust in the IRT vendor (41%), and protocol amendments (40%) came next.
How long does IRT study startup take?
95% of respondents said it takes at least 4 weeks to start a study on their current IRT platform. 56% said 4 to 6 weeks, and 39% said more than 6. Only 5% reported startup in 1 to 3 weeks. For a sponsor working toward first patient in, those weeks sit on the critical path.
How long do protocol amendments take in IRT?
Amendments are routine. Over the prior 18 months, 44% of respondents saw 1 to 3 per study, 42% saw 4 to 6, and 14% saw more than 6. And 45% said each one takes 4 to 6 weeks to implement in IRT. Across a study with 4 or 5 amendments, the IRT change queue alone can add up to months.
What clinical teams want from a new IRT platform
The wish list maps straight onto the pain points. 61% ranked quick study startup in their top 3, and 58% ranked faster amendment implementation. Cost-effectiveness came next at 48%, followed by system flexibility (37%) and pre-validated configurations that need no custom code (34%).
What matters most when choosing an IRT provider
Data quality leads by a wide margin: 88% rated it important or very important, and 71% chose “very important,” the highest share of any attribute. Ease of use (84%) and the ability to handle changes quickly (81%) came next. Clinical operations drives the decision at 86% of organizations, and 62% want a provider that covers study build, consultative guidance, and UAT support.
Why switching IRT providers is hard
The friction is operational. 82% ranked qualifying a new provider with procurement as a top burden, followed by new third-party integrations (72%), analyzing the market (71%), and losing investment in current customizations (71%). Teams do switch, though. 68% worked with 2 or 3 IRT providers in the past year.
IRT FAQs
IRT (interactive response technology) manages randomization, treatment assignment, and investigational product supply in a clinical trial. It’s also called RTSM (randomization and trial supply management). Read more in What Is IRT in Clinical Trials?
In YPrime’s survey of 100 clinical research leaders, the top IRT concerns were timelines and delays (62%), lack of technology flexibility (41%), trust in the IRT vendor (41%), and protocol amendments (40%).
95% of respondents said IRT startup takes at least 4 weeks on their current platform, and 39% said more than 6 weeks.
45% of respondents said 4 to 6 weeks per amendment, and about a third said 1 to 3 weeks. With 56% seeing 4 or more amendments per study, amendment speed has a direct effect on trial timelines.
Respondents ranked data quality (88%), ease of use (84%), and the ability to handle changes quickly (81%) as the most important attributes.
Author
Author
Mark Maietta
President, YPrime
Planning an IRT build? The Biotech Sponsor’s Playbook for IRT Success covers the design questions to ask before you commit to a system.