If you have a routine chest cold, would you see a primary care generalist or a specialist? If you are diagnosed with a malignant tumor, would you make the same choice? Of course not. We regularly choose between specialists and generalists in various aspects of life. And that same logic applies when deciding on a clinical trial drug supply partner.
The stakes for your choice can be high. According to a recent Tufts study, a third of all drugs shipped for clinical trials go unused. That percentage becomes even more dramatic in trials that involve comparator drugs, where 30-55% go unused. If the unused drugs are generic acetaminophen at $0.02 a pill, the waste won't derail your study budget.
The impact can be severe, however, in trials using biologic oncology, hepatitis C and other drugs for comparators, combination therapy and standard-of-care or rescue medicines, where the cost for each study participant can run into the tens of thousands of dollars. The painful effect of product overage costs on multimillion-dollar study budgets could have you reaching for that acetaminophen.
Pharmaceutical companies increasingly turn to outsourced clinical trial drug supply providers to help manage this cost and to ensure that trials don't go awry because of supply chain issues. As comparator budgets continue to grow, this outsourcing trend is strengthening. A key question in outsourcing is whether to select a specialist or a provider that offers clinical trial drug supply as an add-on to their core business.
Here are a few questions to consider as you decide between a drug supply specialist and generalist. Does your trial require:
If you answered 'no' to these questions, it likely means your trial could be well suited for any supply partner. But, if you answered 'yes', consider the following as you look for the right specialist drug supply partner.
The globalisation of comparator trials has added an unprecedented layer of complexity to all aspects of their management, including supply. Look for a partner with the expertise to anticipate issues and develop a plan that minimises risk, including establishing reliable pricing forecasts, avoiding counterfeit product entering the supply chain, and obtaining and completing required documentation to eliminate shipment delays. Comparators and co-therapy products are tightly protected by their manufacturers - issues that experienced supply specialists excel at working through. The right specialist can provide unique insights to solve challenges brought on by limited or restricted supply.
With clinical trial planning timeframes getting shorter, rapid access to information becomes imperative. When sudden changes - such as reduced product availability or the addition of a hard-to-source country - occur mid-trial, the flexibility and experience of a good specialist can mean the difference between success and failure.
When planning for a clinical trial, it's important to secure a partner with the proficiency to match the demands of your trials. Consider factors like overall trial supply experience, supply network integrity, staff training and specialisation, as well as procurement and logistics expertise. Is a generalist sufficient to do the job? Or do you need the skill and focus of a dedicated clinical trial drug supply specialist? The decision you make early on can have a significant impact on the ultimate outcome - and true cost - of your trial.