Direct to patient trials have surged in popularity in the wake of the coronavirus pandemic, offering several benefits to patients and clinical trials sponsors. Vanessa Dekou, Managing Director at Clinical Services International, reflects on the opportunities and challenges this creates for comparator sourcing partners.
There’s little doubt that COVID-19 has disrupted the clinical trials industry, with many pharmaceutical companies reconsidering the best ways to reach patients, and so it’s no surprise that one outcome of the pandemic is the drive towards direct-to-patient (DtP) trials where possible. Many sponsors recognise the benefits of increased patient diversity, improved patient recruitment and retention, and reduced site visits, particularly for vulnerable patients with compromised immune systems. Logistics companies are keen to benefit from the increased demand – writing a lot of online articles extolling the virtues of DtP trials! – but what does this potential shift mean for comparator sourcing companies? How can they prepare themselves for a possible change in the landscape of clinical trials?
From centralised bases to multiple depots
In most instances, clinical trials are conducted through test centres – often hospitals – in various countries around the world, with one or more centralised bases supplying the centres. In such a model, the logistics of comparator sourcing and delivery are orientated around these supply hubs. In contrast, DtP trials rely on timely supply to multiple depots where an authorised distributor takes over the supply chain. This multiplication of delivery sites introduces a significant degree of logistical complexity and introduces a further ‘node’ in the cold chain.
“Simplicity does not precede complexity but follows it.” Alan Perlis, computer scientist
‘Just-in-time’ deliveries
Hospital sites or test centres often have the storage facilities to handle all the necessary drugs for the duration of an entire clinical trial, so may only need to receive two to three deliveries, simplifying the comparator sourcing supply chain. In contrast, authorised distributors in DtP trials are unlikely to have the capacity to store clinical trial supplies on-site to then be distributed over an extended period. Instead, DtP trials rely on multiple ‘just-in-time’ deliveries to depots, for near immediate distribution to patients.
A comparator sourcing solution needs to allow for an increase in the volume of deliveries with much tighter deadlines and less margin for error. At CSI, this is nothing new; we have a wealth of experience in running oncology trials that can include over 30 different medicines, all requiring just in time delivery. These are generally open-label trials, and patients often self-administer the drug, so the products are sourced locally. Although this adds considerable complexity, we have all the necessary tools to manage supplies with an excellent success rate.
Local versus international
This move towards patient administration and in-country sourcing has eliminated the need to relabel the medicine or comparator. Yet this potential advantage is not without its downsides. Locally sourcing comparators poses challenges, such as limited supply and a non-competitive market, making it harder to meet a sponsor’s competing desires for convenience and reduced cost. However, at CSI we put patient safety first and, to do that, we work either directly with manufacturers or authorised country distributors to ensure continuity of medication.
Efficiency is the primary driver
Cost, however you spin it, is still a primary concern for any clinical trial sponsor, and we understand that. Local sourcing and DtP distribution can carry significant cost implications, although these may be offset by certain advantages such as increased patient retention and compliance. Working with an experienced comparator sourcing partner with an extensive database and well-established relationships with manufacturers and suppliers will be even more crucial than ever in helping to develop the most effective and efficient comparator sourcing solution.
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