“Patient-centric clinical trials” is a hot topic in the pharmaceutical industry today.
To be “patient-centric” is to consider in a new way the needs and realities of the patient experience, and to allow that understanding to inform your clinical trial all the way from study design through final visit.
The idea itself is simple — to proceed in a manner that is informed from the outset by what works and doesn’t work best for the patient (as opposed to the makers-of-protocols). The goal is to reduce dropout rates, to increase feasibility, and enhance patient satisfaction. By essentially shifting “power” to the patient, the potential for successful execution of a clinical trial is dramatically increased.
In the same spirit, we’d like to propose a ‘study-team-centric” model of clinical trial execution. To be team-centric means more or less the same thing…to consider the basic needs and realities of study teams – including PMs, Monitors, and Site personnel—with the same eye on ease, clarity, simplicity, and workability.
Since Veracity Logic specializes in Interactive Response Technology (IRT/IWR/IVR) systems, we look here at team centricity as it can be applied to the world of IRT. Below are three quick examples of a “power-to-the teams” philosophy as applied to specific IRT functions:
Managing Sites and Users
Project Managers can manually or via easy imports manage the addition, activation, editing, and deactivation of study sites and system users, either on a single basis, or as a group. No need to involve technical personnel or vendors to maintain, make changes, etc… And study permissions can easily be reconfigured to distribute this capability to other user roles – for example, to Site Investigators or Monitors who are the first to know if a user needs to be deactivated.
Managing Resupply Levels for Sites
Project Managers can manually or via easy imports manage changes to the initial quantity, baseline quantity, and alert levels that inform the shipment request triggers for their study. Do you have a site that is enrolling faster than expected? Clinical Project Managers (or Site Monitors, if given access) can increase the amount of drug to be maintained at the site (the Baseline Quantity) and/or the Alert Level (which, when reached, triggers a shipment request) for the site without having to involve technical support staff.
Custom Reports on Demand
Conventionally, systems focus on providing ‘canned’ reports, adapted (at time and cost) for each individual study. Custom reports and ad hoc queries can mean time delays and additional costs. By comparison, a team-centric approach to reports puts control in the hands of the study team. Each data table in our VLIRT® system, for example, allows a one-button .csv data export which then permits the quick manipulation of data in programs like Excel. By keeping power with the team, answers are available quickly, and at no additional cost.
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