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There are many different ways of comparing the effectiveness of a clinical supply chain logistics; some methods are more effective than others but all have their caveats.
Clinical supply chain logistics and review can be challenging at the best of times; comparing supply chain efficiency between clinical studies presents a myriad of variables. There is always a risk that inter-study variables lead to comparing metaphorical iPads with octogenarian females (we'll call them Granny Smiths) when actually it is only tenuous similarity allowing apples to be compared with apples. However, in order to effectively measure supply chain performance between clinical trials, study-specific performance indicating metrics need to be developed.
(IMP) overage
Measuring investigational medicinal product (IMP) overage is an interesting metric, at first glance a supply chain which allows little wasted drug seems efficient and in some cases this is a valuable point for comparison. However, with all clinical supply metrics other factors must be considered. Little or no stock being stored at clinical sites can lead to multiple shipments to investigator sites, increasing the study's courier budget; even worse, patients may be withdrawn from the study if medication is not available for their site visits. For low value IMPs this metric could be overlooked but taken seriously for expensive medication.
The courier budget
It may be worth considering but how many studies have the same number of sites in the same countries? Furthermore, shipping temperature sensitive products will usually have increased costs due to the added volumetric weight associated with cold chain and temperature controlled shipping systems. It is unlikely that a rare condition with a sparse patient population spread over many investigator sites will have the same courier fees per patient than a relatively common indication. Autologous therapies introduce an additional layer of complexity and cost to courier budgets; as well as supplying patient-specific medication there is a significant addition to the supply chain, taking tissue/biopsy samples from the patients to manufacturing facilities for processing.
Consider the study's patients
Did any subjects withdraw from the trial because of problems associated with obtaining medication? Again, this is not such a simple metric; it is not uncommon for comparator products to become scarce during a study. The inability to supply may not be a failure of the clinical supply chain but may be related to failure of the comparator's supply chain, which in most cases is beyond the control of the study sponsor.
Most clinical trial supply chain operatives have a scientific background; by nature scientists find empirical measurements far easier to trust than subjective observations. However, there is always merit at the end of a study in asking the supply team about their feelings regarding the success of the study. Typically, a happy study manager is usually associated with a successful clinical trial, nevertheless be on the lookout for irrational euphoric compensation as a result of catastrophe, confusion and (Ukrainian) Customs.
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