IRT systems can make your trials run smooth and efficiently, but unexpected variants can occur. Proper contingency planning can make unexpected eventualities a little easier to deal with. There could be a time in an IRT trial when the system cannot dispense medication for one reason or another. This may be due to a system outage, or due to drug shortage or any combination of events that prevent the system from assigning study drug per the requirements.
There are two levels of manual assignment of drug in the IRT world, one-offs and campaigns. One-offs are generally isolated incidents and are more likely to occur when there is a brief system outage where a subject is on site waiting for drug. The campaign level of manual assignment comes into play when a large amount of manual assignments will be required for the foreseeable future.
Both of these types of circumstances can be accounted for during study start up with the proper planning and the full understanding of all the stakeholders. Furthermore, since most study designs involve blinding, unblinded resources will need to be identified and designated. Clinical study teams need to be intimately involved in the process and decision making about when manual assignments are appropriate and when it’s better to just wait for the system to recover. Manual assignments are inherently risky and can result in a compromise of the study blind, cross treatments, and overdoses when they go wrong. Any IRT vendor offering to perform manual assignments should be perfectly clear that they should be reserved for extraordinary circumstances. In other words, a last resort should not be a first option.
One-off drug assignments best serve occasional interruptions in the normal dispensing functionality in IRT. Any manual dispensing should be documented at study start up and include a plan for sponsor authorization, notification and documentation of the manual dispensation. It’s crucial to have these items in place before they are needed rather than try and put them in place in the middle of an emergent situation. One-off assignments will need to be reconciled in the IRT data base to ensure that the site’s inventory and subject’s dispensation records account for any manual assignments.
A situation where one-off manual assignments is most common is during an unplanned temporary outage of the IRT. This is when the risk of the subject not receiving a kit outweighs the risk of being rescheduled for the visit. They can also occur if a subject requires a bolus kit due to a circumstance that is not accounted for in the system or study protocol.
Manual assignment campaigns are more common pre-go live of IRT when the system cannot be ready prior to first subject in and the sponsor assumes the risk of getting subjects into the study in the absence of an IRT. These campaigns are broad and cover all sites in a study or region.
Again, as with one-off assignments, campaigns should be documented at study start up and include a plan for sponsor authorization, notification and documentation of the manual dispensation. Campaigns will require a much more substantial level of reconciliation once the system picks up with automated assignments. This is where the planning aspect pays off. Good campaigns will have pre-made worksheets that mimic IRT functionality in regards to visit data that would be collected by the system and are easily integrated for reconciliation once the system is available again. As with one- off assignments, campaign level assignments are inherently risky and the sponsor should understand the risk prior to engaging in them.
Manual assignments are a fact of life in the IRT world. They are risky and labor intensive. But with proper documentation and understanding, they can save the sponsor from turning away subjects who may be in dire need of their study drug.
