When NOT to use an IRT

IRT Essentials

As a dedicated IRT provider for more than a decade, Veracity Logic has deployed many systems for subject randomization, subject management, and management of study drug for all phases of clinical trials, including numerous Phase 1,1b, and 2 exploratory trials.

But a lingering conundrum in the industry with regard to these smaller studies is this: At what point does it stop making sense, in terms of per patient cost and savings in manual effort, to use an IRT system at all?

We help clients sort out the pros and cons of this question before irreversible commitments are made one way or another. The key factors for Sponsors to consider when deciding whether or not to use an IRT, while obvious in one sense, can get a bit muddy in others. Grids like the one below can help sort things out.

Replacing Study Subjects

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Problem:

Figures presented at a recent North Carolina pharmaceutical conference show that 50% of the clinical sites selected to conduct a clinical trial will enroll zero or only one subject. Even with the advent of social media initiatives and other creative new ways to boost recruitment, enrolling an adequate number of subjects in a timely fashion remains a critical issue for the drug development industry. Eligible subjects, in a word, are precious.

Precious, too, are randomization schedules and statistical design. A second wave dilemma comes after an eligible subject is finally enrolled, assigned to the next slot in the randomization schedule, and then turns out to be, for one reason or another, a case of early withdrawal. Not only does this impact the goal of a treatment group’s minimum number of subjects, but –importantly – it impacts the balances and ratios built into the study randomization schedule at study startup.

Use of Quarantine Strategies to Leverage Investigational Product

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Challenge:

The cost of producing an adequate store of investigational drug for a clinical trial remains high – significant enough that new ways to forecast manufacturing quantities, predict optimal shipping schedules, and differentially assign drug to sites based on enrollment estimates are constantly being developed.

How might IRT systems provide additional methods of minimizing drug waste during a study?

Getting Data Sooner with IRT Part 2

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The Challenge:

In a recent post (see hot topic “Getting Data Sooner”) we talked about how using a ‘give some, get some’ strategy in an IRT system contributes to getting your clinical trial data faster. Users are motivated to enter data in a timely fashion because use of the IRT is required for the site to get critical information required for study conduct and subject treatment — for example, their next kit number, or a dosing calculation. Visit data must be entered before the visit can be accomplished…as distinguished from an EDC system where data entry by the site can lag considerably behind.

But what about data that you want to capture in the IRT which doesn’t fit the ‘give some, get some’ strategy? For example, screen failure, early withdrawals, or receipt of drug shipments. For these kinds of data there is nothing the user requires from the system that would force them to do timely entry.

The Solution:

For instances like these, Veracity Logic’s VLIRT® system provides motivation by appealing to basic principles of human psychology… and by manipulating visit/response windows.

For example: When a subject fails screening, the subject obviously does not show up for their next visit. VLIRT® tracks visit status on the main Subjects page (the landing page for most studies) and turns the name and date of the next scheduled activity bright red once the timeframe for that activity has lapsed. Site personnel, our years of experience attest, don’t like to see red — they know their CRA will also “see red” and will be soon demanding to know what’s happening with the subject in question! Users are thus motivated to eliminate this warning color from their table views by entering the necessary screen fail activity.

The same applies to receiving shipments. Acknowledging receipt is a key factor in keeping site drug inventories accurate and up to date within the IRT. The system can assist by turning red the Sent Date of any shipment that was sent more than X days previously and has not yet been modified to a status of Received.

When selecting an IRT, Program Managers should give careful thought to the application of creative designs that can help solve some of these common problems of clinical trials.

Getting Data Sooner With IRT

Case Studies

The Challenge:

A classic problem in the conduct of a clinical trial is how to motivate site personnel to enter their clinical data in a timely fashion. What can be done to enable project personnel to receive study data sooner?