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)
One IRT proponent, a member of a leading CRO, put the opposite view succinctly: “You have to be crazy not to use an IRT!” Veracity Logic, a long-established provider of IRT services, wholeheartedly agrees.
Here’s the truth about IRTs:
- Randomization: To be sure, there are bargain basement providers of simple randomization schedules. But for sophisticated statistical manipulations that help save time, product, and money, IRTs are the technology of choice. For example, there are cases of complicated stratifications handled easily by IRTs. There are adaptive randomization schema that permit statistically-valid deactivation of failing treatment groups during a study. There are dynamic/minimization approaches that create balanced randomization schedules on the fly based on the experience of the trial itself. There are statistically-endorsed forced randomization models which minimize drug issues by permitting sites to select to randomize based on drug availability at the site. And so on. IRTs provide an array of options, often pre-configured, that enhance effectiveness and efficiency in a clinical trial.
- Shipping and Drug Supply/Inventory Management. Alas, horror stories abound about diehard attempts by Sponsors and Sites to handle shipping and drug supply via paper or spreadsheets. Here at Veracity Logic we wish we had a nickel for every time a frazzled client has come has cried uncle and shouted for help. IRTs are designed to easily provide the status, tracking, and history of shipments and site drug inventory throughout a trial. “I can’t believe we thought we’d save money by doing this ourselves!” offered one client project manager.
- Drug dispensation at visits/titration management: IRTs are a one-stop shop for dispensation/dosing records during a trial, dispensing by means of kit randomization scheme, and offering simple approaches to handling complex problems that can occur – for example, dealing with subjects who need to take a drug hiatus and then return to a modified dose, missed dosing/visits, visits that should have included drug dispensation but, for clinical reasons, did not, restricting dosing modifications to only one up or down level. And so forth. And an array of select information can be fed into most EDC platforms easily, and in a manner that reduces the need for subsequent reconciliation. There is no easy manual equivalent to these IRT services.
- Temperature control, drug accountability, returns and destructions: The IRT provides a cross-Site, cross-country, centralized docket in which to record and monitor the status of these important clinical trial logistical issues.
- Time and money: In fact, using an IRT can save both! Here are a few examples of how:
- Predictive Resupply: A good IRT system will offer the ability to enter a sophisticated complex of variables that figure into how often and how much a site is resupplied with drug to optimize efficiency, certainty, and budget all at the same time. And it can do so by Site.
- IRT platforms are the ‘first in’ spot for clinical trial data – subject screening and enrollment, etc. IRT systems enjoy a much higher compliance with the desire for early and timely entry of data than do EDC systems. This is because Sites must use the IRT to carry out their trial activities – i.e., receive a Subject ID, a Rand ID, a kit number for each visit, and so on. This means trial data starts to roll in 10 or more days earlier on average than with EDC data.
- Last but not at all least, IRT costs generally tend to remain at the low end of pharmaceutical technological requirements. And within the IRT world there are further significant differences in costs, often attributable to differences in overhead. For example, Veracity Logic’s distributed network model, according to our clients, places it squarely in the ‘value proposition’ end of the normal range. In addition, changes during a trial are often made more quickly and more inexpensively with small IRT providers than with large ones. Sponsors can control costs by being sure to ask for proposals from multiple IRTs.
We could go on. But we’ll stop here… for now.
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