Are Clinical Trials Headed Towards Decentralisation?
Introduction
Decentralised clinical trials are increasingly being touted as the future of clinical research. By shipping drugs directly to patients and managing trials remotely through telemedicine, researchers are delivering a truly patientcentric trial right from the patient’s home.
It’s a complete paradigm shift from the traditional clinical trial model and has obvious benefits for patients, who are no longer required to regularly travel long distances to take tests and collect medicine at trial sites. Anything that makes the patient’s experience easier directly benefits sponsors, too. Improved enrolment and decreased dropout are some of the key drivers of decentralisation.
There is also the opportunity to enrol patients located further outside of the trial site’s typical research pool. For studies focused on rare diseases, this could make a big difference to patient inclusion. In some instances, it also allows sponsors to reach a more diverse group of individuals, one that better reflects the real-world distribution of patients.
Alongside all these aspirational reasons to decentralise trials, the recent pandemic was the true catalyst for change. “With the outbreak of Covid-19, patients suddenly couldn’t get out of their homes to go to a trial centre for evaluation or to collect medicines,” explains Ian Hoban, Business Development Director, Abacus Medicine Clinical Trial Services (CTS). “This added a more pragmatic, practical drive to decentralise trials – to keep trials continuing under those adverse challenges. A lot of clinical trials have patients who are immunocompromised and at high risk of an infection really taking hold. I think the hand was forced to a certain extent.”
Key technologies
Remote trials benefit from a number of key technologies, including electronic applications that guide patients to take the right dose of medicine at the right time. Telemedicine enables easier and more frequent conversations between researchers and patients, meanwhile wearable technologies and other remote monitoring tools can be utilised for automated, digital data collection. Done the right way, decentralisation comes with the potential for patients to be better managed from their own homes than ever before.
“These sorts of technologies were already there, but in the face of Covid they’ve come to the forefront and increased in adoption,” adds Hoban. “The supply chains for test results are a lot better managed than they were pre-Covid. Interactive response technology (IRT) continues to develop too.”
Another area of clinical trials that had to be rethought was the medicine supply chain, specifically the delivery of medication to patients’ doors or nearby pharmacies. Luckily, direct-to-patient (DtP) shipments weren’t a new thing, either. A whole industry of DtP logistics providers has grown in the UK since legislation was passed enabling this in 1995.
Supply Chain Challenges
A longer, more complex supply chain with more steps means more room for things to go awry, however. “One of the historic issues with the supply chain is getting the medicine where it needs to be with adequate time and the right length of expiry date, in line with the requirements for the sponsor. That’s probably more important now than ever before,” explains Hoban.
To effectively decentralise the clinical trial supply chain, sponsors require comparator sourcing strategies that ensure expiry dates aren’t going to cause any unforeseen problems.
Abacus Medicine CTS is part of the Abacus Medicine Group and a key provider of comparator sourcing solutions to the global clinical trials industry. The CTS Team has built a reputation for sourcing clinical trial supplies with the most optimal conditions of shelf life, batch diversity, and origin – all while keeping costs to a minimum.
“For decentralised trials, it’s especially incumbent that we meet our promises on expiry dates,” says Hoban. “We’ve got really good oversight of the European market from our IT systems. We can see what the current shelf lives are and advise our clients accordingly. Working with the sponsor’s chosen logistics partner, we then make sure that the medicines get there in time so that they’ve got a good enough shelf life to meet any additional demands in this area.”
Another change the CTS Team has observed is the trend for sponsors requiring smaller, more frequent deliveries of comparators rather than the more traditional large volumes. Whether this was in-part due to trial decentralisation, or more as a response to the numerous supply challenges that resulted from the pandemic is unclear.
A hybrid future?
As many other areas of life returned to normal, the clinical trials industry has found itself in an interesting place. The sudden shift to decentralisation introduced a number of challenges related to regulation, data issues, and patient compliance, as well as the introduction of new, more complicated supply routes.
“There’s an ongoing need to analyse the pros and cons of decentralisation since Covid raised its head, and decide which areas were useful in a crisis but not necessary in the future and which areas have really brought things forward. Companies don’t need to go for an all or nothing approach – as always, a hybrid approach will typically deliver the optimum outcomes.”
The global pandemic may have forced the trend to pick up considerable speed, but decentralisation has long been on the horizon and doesn’t appear to be disappearing anytime soon. Sponsors must now focus on understanding how to minimise the risks that have been introduced, as well as strengthening their supply chains through the right partnerships.
