Play It Again, Sam: Why Use an IRT?

IRT Essentials

We sometimes hear spirited discussions at industry conferences between Sponsors who can’t imagine executing their clinical trials without including an IRT (IWR/IVR) system in the technology mix, and Sponsors who remain partial to things like randomization houses, spreadsheets (still!), supplier-direct approaches, and the like.

Two misconceptions on the part of IRT-naysayers are immediately obvious to observers of this phenomenon:
• The belief that IRTs are always ‘expensive’ – (no, they’re not)
• The belief that IRTs are very limited in what they can do – in essence, are just a way-more-expensive way to randomize subjects – (no, they’re not)

The Classic Conundrum: “How long will it take to make a system change?”

Case Studies

A never-ending tension in clinical trials exists between a client’s need for quick changes to a technical system – for example, an IRT (IWR/IVR) system in production — and the vendor’s need for time.  The axiomatic truth is this: the details of clinical trials are often fluid, with the need for changes commonplace. But Sponsors and CROs often get frustrated …

Checklists can save you — stress!

IRT Essentials

Everyone makes mistakes – it’s part of being human. We’re not automatons who simply complete tasks day in and day out. If only life were that simple. It seems there are always small “tweaks” to any process involving information management and processing. The question is, how do we minimize errors and remove stress from our lives?

One answer, simple though it seems, is to create checklists — quick, focused lists of reminders. Most of us already have Standard Operating Procedures (SOPs) for each of our processes. Yet few staff find it convenient to re-review an SOP during the execution of a task — not only have they already been trained in that task, but many SOPs are complex documents with more (or less!) information than they need.