Surprisingly, closing out a clinical trial can be as complex as starting one, especially where clinical ancillary materials are involved. Clinical ancillaries include a broad range of materials, from consumables to specialized equipment. Managing the return and/or destruction process is a complex logistics challenge with many considerations. When should the planning begin? As soon as possible, typically once study start activities are completed. The disposition approach (e.g. destroy/return/store) and project plan for each site and supporting distribution facilities should be established well in advance of the last patient visit. Because of the complexity, a strong Project Manager is essential to coordinate the overall process.
- Rolling or Universal Timing
The first decision is when to start the closeout / return process. Where a study has involved multiple regions and sites, a Sponsor may choose a ‘rolling’ strategy, closing out sites where patient visits have concluded. Alternatively, they might choose to wait until the overall study has concluded handling everything at once. In either situation, it is generally prudent to allow a short period of time following the last patient visit to accommodate unforeseen circumstances e.g. having to resupply a patient.
- Inventory Management
The Project Manager must obtain inventory disposition reports from the distribution centers supporting the study. In parallel, it is essential they review investigator site supply inventory. After reconciling the reports the Project Manager can evaluate and report the projected costs associated with what is returned, destroyed or stored for future use.
Based on the nature of the inventory, it may be more cost-effective to dispose or destroy materials locally rather than return it to the Sponsor and/or supporting distribution facilities. For example, consumables often have a low price point per unit and have an expiration date. If the item is about to expire and has a low price point, disposal/destruction costs may be reduced by having the site manage this locally when possible.
When materials need to be returned, corrugate boxes, airway bills and labels should be supplied to ensure a seamless process. Including a detailed checklist with instructions helps guide the investigator site staff and can support documenting the expected returns. Items that are not considered consumables (e.g. equipment) must be handled appropriately at the end of a trial in accordance with Sponsor’s expectations and country regulations. In the event of a global trial, import/export paperwork must be completed per regulatory guidelines. The Project Manager will need to arrange appropriate transportation for the return shipment. When supplies are returned to a 3rd party distribution center, a final reconciliation will be performed upon receipt.
- Completion Timing
Several variables can impact the time it takes to complete the closeout phase of a trial, such as: project complexity (number of sites, countries and ancillary SKUs), decision timelines surrounding inventory disposition, site return shipment turnaround time, and the time needed to reconcile site returns upon receipt. The most common delay tends to be associated with individual investigator sites who are not timely in their return. Because this delays the overall study closeout, Project Managers must be diligent with their follow-through, coordinating with the Sponsor or Clinical Research Organization (CRO) for resolution.
When a trial is concluding, Sponsors are sharply focused on progressing to the next phase of the study. The complexity of the closeout and returns process is daunting and time consuming. Sponsors greatly value the support of a trusted partner to manage the details of what’s outstanding so they can remain focused on the drug development process. Receiving a detailed cost evaluation provides Sponsors with excellent visibility for budget management. Many note the value of the time, resource and financial savings based on the partner’s clinical ancillary supplies experience and recommendations.
Follow a biopharmaceutical company entering a Phase III trial that included 45 countries and an enrollment target of 4,000 patients in a randomized, double-blind, placebo-controlled study.