Why IRT Needs Its Own Commandments

Clinical trials rely on Interactive Response Technology (IRT) every single day — yet too often, we treat it like a flexible catch-all system. Randomization? Sure. IMP management? Of course. But then someone says, “Can’t we just collect this extra data in IRT? Can’t we just bolt on another workflow?”

That’s how trouble starts.

The truth is simple: IRT has a core purpose. It’s there to randomize patients, manage investigational product, and provide a controlled way to unblind when necessary. Everything else is ancillary or a byproduct of these core responsibilities. When we overload it with extras or bend it into shapes it was never meant to hold, the results are predictable: longer timelines, frustrated sites, messy reconciliations, and unnecessary regulatory exposure.

I’ve seen it firsthand. I’ve been in the room when “shortcuts” at go-live blew up months later. I’ve seen sponsors sink enormous resources into reconciliation exercises that should never have been necessary in the first place. And I’ve seen studies jeopardized because the blind wasn’t adequately protected.

It’s not because people don’t care. It’s because the industry keeps repeating the same bad habits.

That’s why I wrote The 11 Commandments of IRT.

These aren’t abstract principles. They’re lessons carved out of hard experience, regulatory findings, and trial-by-fire. Each one exists because I’ve watched what happens when it’s broken. Spoiler alert: it’s never good.

Over the coming weeks, I’ll walk through each commandment one by one. Some may feel obvious. Others may challenge the way you’ve been trained to think about IRT. The goal is that all of them will make you pause and reconsider how you’re approaching IRT systems.

Because here’s the thing: patients are waiting. Investigators are relying on us. And sponsors can’t afford to gamble with timelines or integrity.

IRT deserves better. And so do the people who depend on it.

Follow along — the first commandment drops next week.