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By Fernanda Teles, Head of Global Clinical Operations, DHL Supply Chain
Over the past few years, factors like the Covid-19 pandemic have accelerated the adoption of decentralized – or Virtual - clinical trials. This approach leverages advances in digital technologies, data collection and logistics capabilities to allow patients to participate in clinical trials from their own homes, rather than travelling to an investigator’s site or the nearest hospital. While a decentralized approach may not be suitable for every clinical trial, data from Accenture shows that 24% of clinical trial studies now offer a home-based solution, with that number expected to grow. Considering the positive impact that decentralization can have on patient engagement, and improving patient outcomes, it’s no surprise this is a trend we see on the rise.
From a patient recruitment and retention point of view, our experience shows that decentralized trials increase the number of patients that are willing to take part in the trials in the first place, and once patients are enrolled on trials the ease of participation means that they are more likely to be retained for the duration of the trial. Although decentralization doesn’t entirely eliminate the challenges of patient engagement, removing a key barrier by allowing patients to carry out assessments and procedures at home, as well as completing self-reporting tasks, can go some way to minimizing the current 30% drop-out rate seen globally across the industry.
In addition to this, decentralization helps to address the need for diversity within clinical trials. Lack of patient diversity is a well-known challenge and one that is vital to address if the industry is to improve the outcomes for patients across populations. As access to trials is prohibiting factor for some demographics, decentralization is critical in helping trials reach the widest possible range of patients and ensure underrepresented populations aren’t excluded. Ultimately, improving diversity will improve the overall outcome of the trials by making sure treatments are effective over the widest possible population.
However, decentralization does not come without its challenges, emphasizing the need to work with an experienced and global logistics provider like DHL Supply Chain.
Firstly, clinical trials are subject to very different regulatory environments across the globe, so the successful operation of a global trial hinges on the trial organizers having knowledge of the nuances of the legal frameworks in many different regions. This is a key area where working with a specialist partner can alleviate some of the pressures placed on pharmaceutical companies and Contract Research Organizations (CROs) by drawing on global logistics expertise coupled with the expertise of DHL’s 250 pharmacists across the world.
As well as the broader regulatory and compliance challenges associated with moving pharmaceutical products across borders, within the life sciences and healthcare sector the supply chain is becoming colder and colder as the growth in biopharma products in particular places stringent temperature requirements on storage and distribution. For decentralized clinical trials this means organizers need to ensure they can deliver innovative new treatments and products to the homes of patients in exactly the right conditions, no matter which country they are in. At DHL our industry-leading cold chain infrastructure allows us to support clients with their stringent requirements not just between their own facilities, but right up until the moment the treatment or medical product is in the patient’s hands.
To ensure decentralized trials can be delivered in the most sustainable way, reverse logistics are just as important. At DHL we already ship 100% of our Clinical Trials products within the Clinical in reusable shippers, and as part of The DHL Group we benefit from a network heavily investing in the most sustainable methods of transporting products across the globe.
Finally, offering a decentralized approach may feel like it adds an additional complication to an already highly complex process. At DHL our Clinical Service Centre allows us to consolidate operations under one single point of contact while drawing on the breadth and depth of expertise across the whole DHL Group network, including our fast and secure express shipping which can ensure global delivery of biological samples within 72 hours. This enables us to deliver the most complex and controlled ‘White Glove’ service on the clinical trials logistics market, each package and patient is treated with the care they deserve.
Looking to the future, as the results of direct-to-patient become even more compelling we expect to see their presence continue to grow in the market both in terms of the number of trials conducted and in their impact of diversity and retention. That’s why it’s important that pharmaceutical companies and CROs have the right partnerships in place to be able to maximise their potential and stay ahead of the curve.
