Change is a constant in the world of clinical study planning. In The Art of Making Changes Part 1: Five Keys we talked about the stress change can generate, and about the five essential elements for achieving painless change management for IRT (IWR/IVR) systems. The present article outlines the components of a successful management process for technical change.
Doctors will tell you that change – any sort of change – is hard on humans. As endocrinologist Hans Selye observed, “Stress, in addition to being itself, is also the cause of itself and the result of itself.” Good changes and bad changes alike elicit stress points on psychological scales.
Most clinical trial Project Managers will say the same thing applies to managing changes in clinical studies – especially those that impact data systems (e.g., EDC, IRT/IVR/IWR, etc.)! This includes configuration changes, protocol changes that require changes in how a technical system functions, data changes, process changes…and more.
The recent Outsourcing Southeast conference in RTP, NC highlighted one of the hot topics currently buzzing in the pharmaceutical industry, i.e., the need to define and implement a more patient-centric model of clinical trials.
The concept of patient-centricity in the drug development world consists of several basic struts:
• Engage subjects/advocacy groups as partners in the process
• Develop protocols, processes, and systems that are maximally user-friendly (i.e., long on feasibility, convenience, and common sense)
• Put patient interests and point of view on equal footing with corporate research objectives
Perhaps one of the most inconsistently fulfilled industry regulations in the world of clinical trials is the process for document management, including policies for document retention. Companies vary widely in their approach to these important aspects of drug development record-keeping despite the longstanding industry axiom that says “If it isn’t documented, it didn’t happen!”
David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider that has been successfully deploying IRT systems globally for more than a decade, has a Master’s degree in Information Science and has spent much of his career, first in large CROs, then as IRT co-owner, establishing Standard Operating Procedures (SOPs) for compliant quality control of clinical trial documentation.
It’s not always big things that make a difference in the efficiency of a clinical trial — sometimes it’s the smallest things.
The IRT (IWR/IVR) database is no exception to the rule. The incorrect formatting of a fax or phone number, or an extra space in an email address where automatic notifications are to be sent can wreak havoc with the best laid plans. Likewise, an error in the spelling of a field label, or failing to update the name of an internal infrastructure unit like a new email server can cause significant issues and must be corrected.
The contracts have been signed, the study teams are in place (at the Sponsor/CRO and vendors), and it’s time to hold the startup meeting for one of the first data collection tools that will be used for your clinical trial – namely, the Interactive Response Technology (IRT/IWR/IVR) system.
An IRT is the tool of choice for subject randomization and management, drug assignment and inventory management, and shipping, and as such is often the first point of entry for subject data – data that is then typically pushed to the EDC housing the clinical database. But what do you need to bring to the table to help get the IRT efficiently up and running on your project?
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.