Planning the official EDC or clinical database for an upcoming clinical trial is a unilaterally intense initiative. This is not always the case for other, also-important, applications used during a clinical trial – including collateral systems like Interactive Response Technology (IRT/IWR/IVR).
The IRT serves as a remote ‘front end’ for certain key clinical trial activities. Whereas the EDC is the clinical database, the IRT is widely recognized as the tool of choice for randomizing patients and managing drug inventory and subject drug assignments (including shipping and warehouse/depot interactions). The IRT is also first in line for important information about subject compliance with visit schedules. For many projects, IRT data is pushed to EDC systems on a transactional basis, eliminating the need for redundant data entry by busy clinical site users.
It is somewhat surprising then, that Sponsors in the pharma/biotech world still tend to fall into two groups: those who are savvy about how to find, vet, interact with, develop, and test user requirements for IRT systems, and those who remain novices in this regard. Discussions among representatives from various sponsors at a recent industry conference revealed a considerable amount of uncertainty about how to plan an IRT, including available features, best uses, and how to work with an IRT vendor to configure an IRT to support a new trial. Here are a few basic caveats:
Rule Number One: Include IRT in the mix of technologies at the outset of study planning. IRT is often treated among novices as the proverbial red-headed stepchild – an afterthought, getting attention later in the process rather than earlier. To get the kind of IRT system you want, move it to center stage early in the process.
Rule Number Two: Involve all stakeholders during the design/specification phase. This includes project management, biostatistics, clinical data management, monitoring, clinical supply -- and, if useful, input from experienced site personnel.
Rule Number Three: Talk a lot…and listen more! Using the protocol as a launch pad, a good IRT provider will guide you in reviewing configuration items necessary for your study. That said, they can only provide solutions for the challenges presented to them…be sure to explain any idiosyncrasies of your study as they relate to subject activities, drug handling, blinding and unblinding, drug resupply, drug returns, shipping requirements, and so on.
Rule Number Four: Know thyself! Take a look at why IRT expertise lags behind at your company and what steps should be taken to turn that around.
Kate Chapman of Clinical Technology Consultants Ltd. in the UK addressed this question of how to approach IRT at the annual CBI IRT gathering in 2016. Her presentation --“Developing an IRT Roadmap for your Organisation: Best Practices for IRT Implementation and Global Study Management” -- offers a few thoughts and discussion points for those who are in the ‘novice’ IRT camp and don’t want to stay there. Thanks, Kate!For help in selecting an IRT platform for your study, take a peek at Veracity Logic’s checklist for “How to Choose an IRT.”
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