Regulatory
the decade – it’s no wonder that novelty is so often what makes trials tick. In truth, however, the sudden need for a Covid -style miracle drug is fairly uncommon. While some diseases may appear as complete surprises to doctors and researchers, most are old perennials. To give one example, the global market for oncology clinical trials is around $10bn, even as our knowledge of cancer has developed for over a century. In practice, this means that many clinical trials are actually testing new drugs against established competition, or else exploring how different medications can combine to provide effective treatment. It’s under these circumstances that comparator drugs – the medicines against which trial drugs are tested – are so important. Tom White, the executive vice-president of clinical trial supply at Bionical Emas, describes them as a “fundamental part” of the design process, stressing that no trial can succeed without them. With this in mind, it’s unsurprising that researchers battle to secure the comparators they’ll need ahead of time, partnering with distant suppliers to buy the drugs they need. Clearly, none of this is easy. From sourcing to distribution to regulation, the life of a comparator specialist is fraught with challenges, even as their work remains as crucial as ever.
Compare and contrast Terrence Walsh remembers a time when sourcing comparators was surprisingly lowkey. An industry veteran of three decades, he describes how, in the 1990s, he’d use a contact at a pharmacy to informally link him to distributors. “We totally avoided trying to go to the other company directly,” says Walsh, speaking of the firms that actually made the comparators. He emphasises that the last thing he and his colleagues wanted was for manufacturers to realise their product had a potential rival. But as the comparator strategy expert at Regeneron continues, this Wild West of drug procurement has all but vanished. To a large extent, this is down to the rising complexity of modern clinical trials, something reflected in Walsh’s own work. While Regeneron’s comparator budget was once in the realm of $3m, this year that figure is $220m. But if these challenges of scale have largely been solved by the rise of contract research organisations (CROs) – specialised operators that help trial conveners to secure the required stock – White explains the sophistication of contemporary trials can pose other problems. One, he says, is guaranteeing timely delivery of comparators to patients, a situation that’s hardly helped by the recent popularity of decentralised trials. That’s shadowed by the need to ensure that comparators are of sufficient quality, especially as counterfeit drugs represent a market worth as much
Clinical Trials Insight /
www.worldpharmaceuticals.net
as $432bn. Walsh, for his part, vividly evokes the question of labelling, especially across international frontiers. He raises the problem of what happens if a patient in a foreign country becomes sick from taking a comparator, and doctors at the hospital can’t understand what exactly they took? And even as these issues continue to circle, the need for such medications only continues to grow. With more than 38,000 clinical trials starting in the US last year alone, the demand for comparators will soar as a result – the comparator drug sourcing market is expected to expand at 3.5% CAGR from 2023–31. And quite apart from their importance as drugs to test against – efficacy, cost and side effects are all advantages researchers are keen to compare – both White and Walsh highlight the parallel growth of collaborative trials. These are effectively situations where researchers believe multiple drugs can complement each other, and trials involve manufacturers and researchers working together. Such arrangements naturally preclude straightforward supply problems – if a company thinks their drug can sell more as part of a package deal, they’re obviously inclined to share. Even so, collaborative trials can offer hurdles of their own, especially around exactly how much of each medication patients need.
“I think there’s going to be a lot of companies working together.”
Terrance Walsh
Sharing is caring Listen to both White and Walsh and it soon becomes clear that the solution to these varied challenges can be summarised in a single word: planning. Long before subjects take their first dose, White describes a shopping list of obligations for planners and suppliers alike: “For instance, we’ll need to understand which countries the trial will be conducted in, how will the comparator be used, how many packaging runs are anticipated, when will the study start and end, if there are any specific requirements around cost sensitivity or wastage reduction.” From there, suppliers will need to be found and contracted, and regular review meetings held to ensure comparators are getting to their destinations promptly. As White notes, China and other East Asian countries are increasingly tagged in here, both because of their mature manufacturing and packaging sectors, and because they’re often chosen as the sites for trials themselves. It goes without saying that such cosmopolitanism requires regional expertise – not least to cut through thickets of country-specific regulation. Especially at the biggest multinationals, Walsh says one solution
38,034
The number of clinical trials registered in the US in 2022
ClinicalTrials.gov 9
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