Since Pfizer announced it would be conducting the first fully decentralized clinical trial in 2011, forward-thinking sponsors around the globe have been looking at how to incorporate direct-to-patient elements into their trials in a bid to address some of the challenges the industry has traditionally faced.
This was a trend well underway before the COVID-19 pandemic, but one that has only accelerated as global populations have become more and more accustomed to remote delivery. In addition to COVID-19 there are multiple drivers contributing to the need and adoption of Decentralized Clinical Trials (DCT), due to certain key advantages such as faster participation, improved participation outcomes and the ability to drive patient diversity.
Today the industry is not seeing a particularly high percentage of clinical trials managed in a fully decentralized way, but we know these numbers will continue to grow, particularly as technology develops and treatments advance, lending themselves to a more decentralized approach.
In fact, research shows that these remote approaches to trials are anticipated to increase across all therapeutic areas, with oncology, rare diseases, central nervous system and immunology trials seeing a particular uptick. According to a Centerwatch study in 2021, nearly half of respondents expect to conduct oncology trials with decentralized components in the coming year, an 11 percentage-point increase from the prior 12 months.1
Decentralization can be most helpfully seen as a spectrum, with traditional on-site clinical trials, or ‘analogue trials’ at one end, and Pfizer’s full-virtual approach at the other. In the middle lies a hybrid approach where, depending on the needs of the patients, the Investigational Medicinal Product (IMP) and the trial itself, elements of decentralization can be integrated into the trial design in the most appropriate way. Mixed modality, or hybrid trials, have been shown to lead to the most reliable data outcomes.
Ultimately, hybrid clinical trials represent a flexible approach that allows patients and sponsors to access the benefits of decentralization while mitigating some of the potential risks. This patient-first focus is at the heart of DHL Supply Chain’s approach to clinical trial logistics, and informs both the advice it provides to customers, and the way it structures its Clinical Control Tower offering.
Its teams of specialists are in regular and ongoing communication with patient groups and the wider industry to ensure that each trial is designed to balance the needs of the patients with the needs of the trial sponsor. This allows DHL to be sure that any changes made are ones that it knows patients across diverse groups will be comfortable with and will benefit from.
In addition to this flexibility, decentralization undoubtedly has benefits, from patient engagement to ease of implementation, that can be most readily accessed through a hybrid approach. However it also comes with challenges that need to be factored in. Patients are often expected to access multiple systems to log information which can be off-putting; it requires significant training as well as investment in the right technology.
Boosting patient engagement and diversity
Patient drop-out is a concern for trial organizers, and research shows that decentralization can help with this.
According to McKinsey, typically 70% of potential participants live more than two hours from trial sites, so decentralization broadens trial access to reach a larger number and potentially a more diverse pool of patients.2 DHL’s own statistics show that decentralization increases the number of patients that are willing to take part in a trial in the first place, and once patients are enrolled they are more likely to be retained for the trial’s duration.
When looking at which areas of their trials to hybridize, sponsors can examine their processes for ‘problem areas’, perhaps ones where drop-outs most often occur, and look at how to introduce decentralized elements in those areas or examine the specific need of the trials.
For instance, decentralization can be particularly important in the case of rare disease trials where patients populations are very small and hard to identify, but driving decentralization in these investigators can provide access to a larger pool of patients and help expedite the process.
Wearable technology is particularly helpful in decentralizing a clinical trial and boosting engagement. For example, where patients need regular glucose tracking or need to carry out daily self-reporting tasks, technology like wearable monitors or mobile phone apps can allow them to be in regular contact with their physician, without having to travel to the trial site as regularly.
Although decentralization doesn’t entirely eliminate the challenges of patient engagement, by removing as many barriers as possible we can go some way to minimizing the current high drop-out rates seen globally across the industry.
Unlocking efficiencies
Naturally, increasing the efficiency of a trial is a key concern for trial organizers and something that a hybrid approach can again benefit. In this case, working with an experienced and global logistics partner like DHL is particularly helpful in unlocking efficiencies.
A partner with breadth and depth is likely to be able to quickly flex to accommodate changes to the trial, for example introducing direct-to-patient deliveries in the geographies where they would be helpful, or even bringing on board specialist nursing staff to administer treatment in patients’ homes. Likewise, a specialist partner can help overcome patient barriers, for example concern about data confidentiality, with bespoke solutions such as secure management of patient data and blinded shipping.
Likewise, logistics partners are likely to have bespoke software solutions that can further embed efficiencies within a hybrid trial design. DHL’s suite of online tools and MySupplyChain platform allow trial organizers to drill into the details of their supply chains to maximize efficiency. For example, understanding that a delivery will arrive at a particular time and date allows organizers to then arrange for any necessary additional elements to arrive at the right point, minimizing waste and improving the patient experience.
Hybrid design to improve sustainability
Hybrid trials also bring with them sustainability benefits, particularly when it comes to packaging and the returns process. DHL already ships the majority of its products within the Clinical Logistics team in reusable shippers but can make alternative packaging choices based on the geography and capabilities of the site. For reusable packaging the company is aware of the need to ensure it can be returned in the least cumbersome way possible for the patient. This might mean arranging the return at the same time as the delivery or finding another way to ensure that reusable packaging is actually reused, and the sustainability benefits are earned.
Hybrid clinical trials can and will vary in their degree of decentralization, taking into account many elements including the therapeutic area, the IMP, the patient profile and the geographies in which the trial is taking place. When implemented well, a hybrid model will boost patient engagement, drive operational efficiency and improve sustainability, all the while reducing the time it takes to get an IMP to market, and ultimately get care into the hands of the patients that need it the most.
Author: Aiden Smith, Global Business Development Director, Clinical Logistics, DHL Supply Chain.
References
1. Centre Watch. Hybrid Trials May Overtake Traditional Studies in 2022, New Data Show.
2. McKinsey & Company. No place like home? Stepping up the decentralization of clinical trials.
