Wondering what Interactive Response Technology (IRT/IWR/IVR) is and where it fits in the world of clinical trials? For a brief intro, take a peek at the interview IWRS for Clinical Trials with David Goldston, Veracity Logic’s Managing Director.
One of the much-lamented aspects of a regulated industry like pharmaceuticals is the amount of documentation required for the successful conduct of a clinical trial for new drug development. The old industry adage ‘if it isn’t documented, it didn’t happen’ was with us at the birth of modern FDA trials and it remains just as true today. The move from a predominantly paper-based environment to an electronic environment didn’t change a thing – the lament just moved from one venue to the next!
To complicate matters further, client audits and government inspections make it necessary to be able to lay your hands on a document expeditiously when called upon to do so. Government endorsement of GCPs and document management standards further add a string of ‘must do’s’ to everyone’s SOPs.
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.
Drug accountability and the problems associated with it remain key issues for clinical trial management as we move into 2018.
Using an IRT (IVR/IWR) system to manage the distribution and assignment of investigational product (IP) is now a well established practice. Most IRTs these days also include some method of managing and documenting the return and destruction of IP consistent with federal guidelines which require Sponsors to account for all of their trial’s unused drug.
But IRTs differ in the functionality they offer with regard to accountability.
Having robust information on study visit windows and scheduled activities that is easily configurable (and reconfigurable as need be) is an important requirement when vetting IRT (IVR/IWR) systems for clinical trials. What kind of information should you look for?
First, there are the basics: scheduled activities, activity windows, and options for window enforcement. Here’s a project example from our VLIRT® system:
The ability to track the temperature excursions of an investigational product has taken on an increasing importance in clinical trials. Temp tales and similar devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it is unpacked at a clinical site. The electronically recorded temperature history is available for review by project teams and site personnel on demand.
A robust IRT (IVR/IWR) must be able to take into consideration the real-life, logistical issues associated with the issue of temperature deviation, whether ambient, refrigerated, or frozen.
The surest way for a clinical trial data collection system to be rewarded by users with accolades like ‘intuitive and user friendly’ is for the system to be flexible-by-design — that is, to enable users to modify, by design, standard data views to include project-specific data points whenever the user logs in. This juggling act – standard-yet-flexible – is one of the first criterion one should apply when assessing a new system, whether it’s an EDC, CTMS, ePRO or IRT platform under consideration.
Using the Veracity Logic VLIRT® (IRT/IWR) platform as an example, a system’s architecture becomes ‘intuitive’ when built from the outset to encompass project specific additions to standard views without incurring additional time and costs for custom coding. Modular, configurable flexibility, selected by users at startup, is the key to success.
Do you know:
• How many registered US-only clinical trials are active as of Jan 1, 2018?
As the new year of 2018 begins, it does so with the transition to Risk-Based Monitoring (RBM) one of the key initiatives on the table for the clinical trials industry.
Backed by federal regulators, RBM urges a move away from ‘rote’ approaches to quality control – for example, 100% Source Data Verification — in favor of a variety of heads-up, algorithm-driven assessments of potential trouble spots, with preventive and corrective actions the key focus for study monitoring activities.
Veracity Logic (VL) has contributed to the RBM discussion in these hot topic pages on more than one occasion, highlighting some of the many key data points available first in IRT (IWR/IVR) systems, data that support the RBM initiative (for example: Actionable Intelligence from the IRT for CRAs or Risk-Based Monitoring with IRT)
When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug?
Here’s a quick checklist of things to consider:
Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in a straightforward table view – without the need for complicated querying, and with the ability to deliver or withhold types of information based on user roles. An at-a-glance view should include: