In my years as an IRT subject matter expert, I have come across many different types of users with various backgrounds. All of these users have a valuable part in the larger conversation, and their value is often determined by their need to use IRT. For example, clinical supply users leverage IRT to ensure there is enough drug available at a site to meet the needs of patients. Clinical operations users use the IRT system to monitor enrollment rates in real-time, as opposed to waiting for the lag of enrollment that is often seen in an EDC system. Beyond that, data management professionals use the IRT system to provide data that is later coded and used in SDTM formats and other data transfers. This does not yet include the other users that can find value in the IRT system, like Biostatistics, for example.
When evaluating a fractional IRT subject matter expert, it's critical to examine the lens through which they see IRT development. For example, does your IRT subject matter expert have a clinical supplies background, a data management background, a clinical operations background, or something else? While it's not common to find an IRT specialist who can see the development of the system from all of these angles, there are certain experts out there that bring parts of each of the different domains of IRT development.
Many would say that the most obvious background for IRT expertise is in clinical supply chain. Let's examine the types of requirements that a clinical supply chain professional would monitor and provide feedback during development. Clinical supply planners have early visibility into overage and other production considerations like expiry and retest date, and availability of comparator. As a result, these types of professionals often consider the drug supply functionality to be the chief concern of the IRT system, and rightfully so, considering that IRT was born from a need to balance shipping and production costs. Beyond production and shipping costs, clinical supply experts also monitor and determine resupply strategies, including initial site seating for drug, minimum and maximum safety stock, and short prediction and long prediction windows for patient visit considerations.
Another common IRT SME is a data manager or someone who has a data management background. Data managers often approach IRT development from a perspective of patient visit flow and data collection as a function of transferring data to the EDC system. For example, data management professionals often painstakingly consider the pros and cons of collecting screen failures in the IRT system as compared to the EDC system. Beyond that, data management professionals also consider the value of assigning new subject numbers to re-screened patients. Perhaps the most critical part of the data manager's mindset is thinking about how the data will be transferred and ultimately coded for submission. Generating the unique subject identifier from the IRT system and transferring it to other systems has become the norm in e-clinical development, and data managers are often aware of the value of this practice when developing IRT specification documents.
Of course, the clinical operations team is ultimately responsible for the success of a clinical trial, albeit their success is a function of the teams around them. Clinical operations experts often look at the data outputs as the most valuable aspect of IRT specification development. What this means is that real-time monitoring of screening rates, screen fail rates, and enrollment rates in the IRT system can provide early data to clinical operations teams that is used for critical things like risk-based monitoring and opening of new sites and new countries or regions. While this data is ultimately available from an EDC system, it is generally not entered in those systems until after the fact, making IRT the earliest source of truth available to the clinical operations experts.
So, in evaluating the expertise of a fractional consultant in IRT development, it is critical to consider the lens through which they view specification development, user acceptance testing, and support of the system during the enrolling phase of the study. While clinical supply experts are often seen as the default archetype for IRT expertise, there may be some blind spots in data management and data transfer development to consider. Likewise, when using data managers and clinical operations professionals as fractional IRT consultants, there may be some drug supply or even unblinding considerations that they are simply not allowed to be exposed to.
As outlined above, there are some rare experts that have clinical supplies, data management, and clinical operations expertise, and if you can find them, you will be well served in all aspects of development. The more common route, however, is to find an expert in clinical supplies or data management and supplement them with their counterpart that has additional background. A common model that I have seen building more acceptance is a fractional team of IRT and e-clinical experts that can provide support in each of the appropriate areas, rather than a single resource.
I'm very interested to hear others' perspectives and opinions, not only about the difference between IRT development through the lens of clinical supplies, data management, clinical operations, biostats, etc., but also what additional functions have we not considered when developing the IRT system. Perhaps a future topic could involve e-clinical systems experts and data integration specialists, whose responsibility is to align systems across an entire study, program, therapeutic area, and portfolio.