Before we can address the challenges in the clinical trial supply chain, we need to identify what they are. Based on our research and experience, we’ve come up with the top 4 challenge areas we see.
In order for Clinical Trial Coordinators responsible for providing randomization codes for a trial to do their job, they need to be part of the unblinded staff, and receive education and training in order to understand the unblinded process. Unfortunately, we have recently seen these coordinators being inappropriately blinded: the intention being to limit their knowledge of the details of the trial. Unfortunately, this would also include not knowing which codes are assigned for treatments within a study.
The purpose of keeping people blinded is to eliminate bias on the study, which is why coordinators aren’t given that information. If, for example, the staff knows that some study patients are being given a placebo, they might treat them differently from those receiving active drugs. This can have a negative effect on study results. However, it is important to have someone on-staff who is unblinded so you have someone on your team who knows what the source of any adverse reactions in the patient are. Unblinded staff are better able to properly investigate whether any effects are the result of the drug the patient is taking, and you want to document any adverse reactions to the drug as part of the study notes.
Lack of Communication Strategies
You will have noticed that time constraints are always an issue in clinical trials. A lot of issues could be resolved with clear and strategic communications. We communicate between teams and team members to ensure that information is accurate and up to date, and to report discrepancies as soon as possible. We communicate during scheduling and planning, so that deadlines are realistic and achievable. When issues arise, it’s critical to communicate them as quickly as possible, so that solutions can be implemented without disrupting the supply chain and while keeping sponsor costs low. If errors are realized and/or changes are made and not communicated, your coordinator will have to backtrack through the supply chain and determine where things went wrong.
Things can fall through the cracks during leadership changes. You may change study managers or site managers, i.e. personnel who are in charge of inventory, both of which have an effect. It takes time and effort for us to go through and locate the correct personnel and track those changes.
Communication is again key here. You must ensure you keep up to date records before you hand them off to new leadership personnel. Make sure you have current inventory of all sites that have your product, that you have a key contact at each site, and that you know there are sites that exist with contracts that you can hand off to the new person. Otherwise, it can take months to locate the correct person.
And while things are still under old management, be proactive about keeping up to date with your numbers. Contractors don’t always track your sites when not asked up front, and we won’t know all the information at the site level, so the sponsor should be proactive and take the lead on tracking. Remember: reconciliation can take years as we go through inventory and documents to ensure everything is accounted for. Personnel should get friendly with tools like Excel to help track inventory, which may sound like a lot of work, but will save time in the end.
Distribution & Sites
You must ensure that everyone on-site is trained properly to receive or send back product (for return or destruction), and that temperatures are monitored, where necessary. When products go off-site, others throughout the supply chain might not be as careful or aware. To aid in the safe handling of product off-site, we provide detailed instructions on how to package and ship properly if the drug is being sent back.
We supply your staff with the correct resources and education to handle distribution. For example, we provide instructions on shipment preparation including product handling, ensure that the labels are correct, and assist with filling out forms. All to ensure that staff have the right resources to package their products correctly.