Outsourcing Navigating
omparator studies are becoming increasingly prevalent. Unlike a standard clinical trial, in which the investigational compound is compared with a placebo, comparator studies typically involve testing the drug against an existing treatment. The idea is to find out not just whether a drug is effective, but whether it has the edge on those already on the market.
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This kind of protocol brings advantages for patients, because they’re getting some kind of treatment either way. That brings trials within the scope of seriously ill patients, who might not be eligible to receive a placebo for ethical reasons. Around two-thirds of trials today involve some kind of comparator or co-therapy, largely down to supportive efforts from agencies like the FDA. Unfortunately, these kinds of trials bring added complexities from a sponsor perspective. As Tom Rose, SVP of clinical trial sourcing at Clinigen, explains, comparator sourcing is notoriously difficult. “The challenge of comparator sourcing is the wide range of requirements for products over
complexities
When it comes to clinical trials, sourcing comparators can be a challenge that could expose companies to various roadblocks. There are so many factors to consider, from regulatory and operational risks to cost and waste targets. Tom Rose, SVP of clinical trial sourcing at Clinigen, explains how these risks can be managed and why it’s so important to have a contingency plan in place.
a long period of time with non-linear and less predictable demand,” he explains. “Any one of the requirements for country of origin, documentation, expiry, price, volume, lead time and batch can become a risk as a trial develops, much of which is driven by factors outside of the sponsor’s control.”
Logistical and regulatory challenges Let’s say you’re conducting a globalised trial, in which comparators are sourced and shipped to multiple sites. You will need to contend with a patchwork of local regulation and international shipping rules, along with variations in documentation and possible fluctuations in the quality of supply. If the product needs to be blinded (for example, patients won’t know which medication they’re taking), that can cause additional regulatory or import/export concerns. Meanwhile, temperature-controlled products can pose logistical challenges – how will you manage a network of shippers, working across multiple jurisdictions, who can ensure a comparator is kept within the optimal temperature range?
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