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Tim Holmes, Manager, Clinical Oversight of Supplies, Biogen, offers considerations on how to obtain non-IMP supplies for clinical trials
When planning a clinical trial, sometimes the non-investigative medicinal product (non-IMP) supplies are given secondary thought to matters that could delay study startup, such as budgeting, pricing and procurement. As clinical supply managers we can play a very important part in supporting on-time study startup and the continuity of supply maintenance.
For this article, “non-IMP” supplies are any supplies needed for a clinical trial that are not the sponsor’s drug. With that said, “non-IMP” supplies fall under the following categories:
Sourcing and procuring comparator and rescue medications can raise a multitude of concerns. For one, the cost of using either medication can put a clinical trial way over budget, potentially forcing a study to be scrapped altogether. Global market availability of certain drugs, especially oncology drugs, can be cyclical due to demand or manufacturing stoppages for any reason.
If attempting to source when the supply is low, it could take 3-6 months before there’s ample market supply sufficient for study startup and the full course of the trial. In addition to supply availability, sponsors must ensure suppliers provide medications with an expiry date that accommodates the length of the trial. Receiving short-dated medications means the sponsor will need to stagger provider deliveries with later expiry dated drugs depending on the study’s rate of enrollment.
There are many vendors that can help sponsors source these medications. When choosing vendors, the sponsor should ensure they have the proper licensing, global sourcing and distribution capabilities (e.g. export/import) to meet the requirements their clinical trials. The vendor should advise the sponsor what countries allow the use of the drug being purchased or recommend they procure the same drug locally.
If the vendor cannot provide definitive information on whether the sourced drug can be used in certain countries of interest, the sponsor must validate whether the comparator or rescue drug is approved for use in the countries where the trial is being conducted. Otherwise, it’s encouraged the sponsor applies for special regulatory approval to use that medication. Failing that, the sponsor should consider not running the trial in the proposed country (or countries).
In the event a “preferred supplier” agreement isn’t in place with a vendor, investigate setting up a preferred supplier partnership to strengthen best pricing and vendor service.
If the medication in one of the countries is very expensive (e.g. typically the U.S.) don’t attempt to import the same medication from another country or region using “cost savings” as a justification. Most, if not all the time, when the medication is available in the high-cost country, the drug can’t be imported for use into that country even for a clinical trial. If there happens to be a shortage or no supply available of the medication needed, sponsors may be able to apply for an “exception,” but must present evidence.
If the study is blinded, sponsors need to assess how difficult it will be to maintain the blind if there are any physical differences (e.g. shape, color, solid vs. liquid dose form). Additionally, determine the best method (e.g. over-encapsulation, IV bag and line covers, unblinded pharmacist) for maintaining the blind based on the aforementioned differences.
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Find out moreEquipment sourcing is another area that benefits from a “preferred provider” agreement for pricing and service, so should be investigated if the sponsor company uses a different vendor for sourcing comparators and sourcing rescue medications.
The equipment to be provided to clinical sites typically depends on:
Ways of procuring the equipment can vary depending on sponsor company policy:
This category also has cost and service benefits when the sponsor or CRO has a preferred vendor partnership with a service provider. The service provider may also be able to supply any needed comparator/rescue medications and/or equipment, so it is worth inquiring about the service provider’s capabilities when setting up a “preferred supplier” agreement.
Research into what peripheral support supplies are required and available is needed for each piece of equipment. Some examples are:
Don’t ignore the importance of providing non-IMP supplies for clinical trials. Start your identification, sourcing, pricing, expiry date availability, and delivery dating early in the protocol development process. This is vital so that non-IMP supplies do not become a problem for on-time startup of your clinical trial.
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