By Sylvain Berthelot, Solutions Consultant, Parexel Informatics
With the escalation of COVID-19 affecting population mobility globally, clinical trials are obviously being impacted. Sites are at risk of not having enough medication for their patients, and patients are at risk of having an interruption in their treatment, which not only puts their health at further risk but could result in protocol deviations or discontinuations. In areas where travel restrictions are in place, patients may be unable to reach study sites to complete their visits, and supply depots may not be able to function at their usual pace and capacity, potentially including some periods of shutdown.
As I see it, there are two key challenges that IRT can help address: ensuring sites have enough medication for their patients, and ensuring patients are supplied with medication even when they cannot attend dispensing visits at their study site.
Continuity of the supply chain
Study teams need a flexible IRT system to address situations where a depot may be closing for a certain period or when it is necessary to reduce the frequency of shipments to sites.
Both aspects can be controlled by updating the following parameters in the IRT:
- Site stock replenishment levels that account for new patients or unplanned resupplies
- Extension of the look-ahead period to increase the number of visits covered by the IRT’s predictive resupplies
These parameters should be directly accessible to the clinical supplies team or a super user group, allowing a quick action to react to unforeseen situations. It is important that updates made can be reversed once the situation has stabilized, as these parameters will likely have been setup in such a way to increase the supply chain efficiency, achieving the optimal balance between cost of shipments and medication wastage.
At Parexel, we work with study teams to adapt these parameters considering each study and its specific supply chain structure and challenges. Our supply chain optimization team are leveraging their expertise to help studies impacted by COVID-19 who seek advice on how to ensure continuity of the supply chain, considering recruitment expectations (if recruitment is still open), frequency of patient visits and site storage capacity. We will also help study teams return to a cost-effective balance between shipments and drug wastage once the situation has stabilized.
Reaching patients at different sites or at home
The biggest supply challenges the industry is facing currently is when patients are not able to attend visits at their clinical site. One of the issues it raises is that sites cannot hand the medication to patients during dispensing visits.
In some situations, patients will be able to attend visits at an alternative site also part of the clinical trial. This scenario is relatively simple to manage in IRT, as usually site details can be manipulated intermittently by super users or helpdesk staff. A solid IRT solution will also support site-to-site medication transfer, reducing drug wastage.
The situation becomes more challenging when patients are not able to leave their home, as there needs to be an option to ship medication directly to the patient. In instances when the IRT system is not setup to manage direct-to-patient shipments from the trial onset, ensuring patients receive their treatment can become quite complex. The extended team who can impact the supply chain (clinical supply, depot network, IRT vendor...) need to be creative to find adequate solutions. It is worth noting that IRT vendors do not typically receive patient personal information, meaning that the IRT system cannot directly raise shipment requests to the patient’s address.
Our IRT teams currently support many requests for direct-to-patient shipments from the depot or from the patient’s clinical site; we have been applying processes that will allow to record patient dispensing and ship to patients where it was not planned from the study onset. The choice between depot-to-patient and site-to-patient is usually based on how the study team would like to, or can, handle medication stocks. Our project management and helpdesk staff liaise with the clinical team, depots and sites directly to coordinate shipments, with one goal in mind: making sure patients receive their treatment safely.