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)

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.

Optimizing Timely IRT Compliance

IRT Essentials

A general finding in the clinical trials industry is that entering visit data into an EDC system by clinical site personnel lags, on average, 11 days behind a clinic visit. This issue of belated entry persists in the industry despite the hopes, dreams, wishes, urgings, and incentives offered by Sponsors and CROs for quicker data access.
Typically, IRT (IWR/IVR) systems, which provide clinical personnel with critical information like Subject IDs, randomization to treatment groups, and kit numbers for proper drug dispensation at site visits, enjoy timelier entry of visit data than do EDC systems. This ‘first-in/early data’ positioning makes IRT systems highly valuable components of a trial’s data collection efforts.

Quick Tip from Veracity Logic: Reducing IRT/EDC Reconciliation

Case Studies, IRT Essentials

When integrating an IRT (IWR/IVR) system with an EDC platform, avoid collecting CRF data in the IRT. Optimal goals for deploying an IRT are to screen subjects (i.e., assign a Subject ID), to randomize subjects to a treatment group, and to assign drug to subjects during the trial. We recommend our clients follow a ‘must have’ approach for data collected in the IRT and subsequently pushed to the EDC – in most cases, limiting the data transferred to the Subject ID, Visit ID, and IP assigned.

Quality Through The Ages

IRT Essentials

Imagine it’s 325 B.C.E and you’re at Aristotle’s school, the Lyceum, in Athens. A builder has come to ask Aristotle’s advice. He explains that his workers have not done well with recent jobs and the customers are finding other builders. He has corrected the issues he’s found in the work but this is costing him his profits for the job when work must be redone. He asks, “can you help me?”

Aristotle ponders for a moment, then says, “Quality is not an act, it is a habit.” And so, we have history’s first formal statement about quality: Quality is not a special, ‘extra’ activity, but a way of intrinsically performing one’s work.

Selecting an IRT

IRT Essentials

One of the most popular features ever published on this website is our white paper How to Choose an IRT for your Clinical Trial. The paper includes a comprehensive checklist of important items to consider when vetting IRT (IWR/IVR) systems.
From time to time we like to spotlight this paper as our current Hot Topic, focusing attention on key issues central to IRT selection, and on the offerings of core functionality that vendor managers and other decision-makers should be sure to consider when comparing systems.

Pharma Quality at Biotech Pricing

IRT Essentials

Earlier this year we attended a conference at which one presenter put up a slide titled, “Pharma Quality at Biotech Prices.” We recall thinking what an odd approach to quality this phrase represents. It could be seen to imply that quality is based on the size of a company and on the amounts spent – i.e., that more is more where quality is concerned. But is this true?

The Art of Making Changes Part 2: Focus on Process

Case Studies, IRT Essentials

Change is a constant in the world of clinical study planning. In The Art of Making Changes Part 1: Five Keys we talked about the stress change can generate, and about the five essential elements for achieving painless change management for IRT (IWR/IVR) systems. The present article outlines the components of a successful management process for technical change.

The Art of Making Changes Part 1: Five Keys

IRT Essentials

Doctors will tell you that change – any sort of change – is hard on humans. As endocrinologist Hans Selye observed, “Stress, in addition to being itself, is also the cause of itself and the result of itself.” Good changes and bad changes alike elicit stress points on psychological scales.
Most clinical trial Project Managers will say the same thing applies to managing changes in clinical studies – especially those that impact data systems (e.g., EDC, IRT/IVR/IWR, etc.)! This includes configuration changes, protocol changes that require changes in how a technical system functions, data changes, process changes…and more.

In Search of Patient-Centric Vendors

IRT Essentials

The recent Outsourcing Southeast conference in RTP, NC highlighted one of the hot topics currently buzzing in the pharmaceutical industry, i.e., the need to define and implement a more patient-centric model of clinical trials.

The concept of patient-centricity in the drug development world consists of several basic struts:
• Engage subjects/advocacy groups as partners in the process
• Develop protocols, processes, and systems that are maximally user-friendly (i.e., long on feasibility, convenience, and common sense)
• Put patient interests and point of view on equal footing with corporate research objectives