Neal Pope

With the shift to DCTs, we are finally, and rightly, allowing patients to guide the clinical research journey. This is important because patient-centred design can help remove many of the traditional barriers to trial participation, including the burden of site visits and all the associated expense and inconvenience.

In addition, data captured through wearables and apps can provide new insights, removing the ‘white coat effect’ and allowing study coordinators to closely monitor and respond to participants before potential issues escalate. However, that is not to say DCT implementation is without its challenges and barriers to implementation.

A lack of internationally agreed standards on compliance can sometimes act as a barrier to DCT design implementation. It means that many in the conservative industry may be reluctant to move away from established structures and towards today’s game-changing technology and systems.

A typical pain point is understanding how best to ensure the healthcare professionals (HCPs) hired to visit people in their own homes have access to the products and equipment they need to do their job.

DCTs fundamentally alter the supply chain – rather than sourcing and sending goods to a set, limited number of clinical research sites, sponsors and CROs are tasked with delivering the items to any number of HCPs across any number of countries or regions. Of course, this presents logistical challenges. But it also brings up compliance issues, such as how to meet regional data protection regulation.

To address this compliance and logistics issue, mdgroup launched its network of medical distribution centers in the US and Europe at the beginning of 2021. The initiative involved the development of processes and job descriptions specifically designed to meet current operational and data protection demands, giving organizations confidence in their compliance across regions.

This model addresses supply chain logistics, allowing sponsors and CROs to deliver high-quality medical equipment, lab, nurse, and patient kits to their global HCP teams quickly and cost-effectively, as well as ensuring HCPs are equipped to respond to participants’ needs, thus strengthening links in the clinical trial supply chain.

The move to DCTs can be a steep learning curve, so the clinical trial technology sector must work with project teams to identify and overcome challenges. In actuality, there are a raft of considerations for project managers setting out on their decentralized journey. Chief among them is the understanding that, if they are going to yield quality, usable data, home visits must be embedded in and guided by the needs of the patients. In addition, no two studies are the same, so it is important to choose technology platforms that allow teams to choose their own elements and set their own levels of automation and individualization.

It is also vital researchers know they will be able to offer the same level of service in people’s homes as they would on site. The guiding principle should always be providing a quality, reliable service to those who need it most – or getting the right product to the right place at the right time. It’s an objective the distribution center model, which relies on strong teamwork between supply chain, procurement, account directors and project managers, is designed to address.

While technology has enormous potential to engage previously underrepresented groups, it is important to remember not everyone has equal access to digital tools or the skills to use them and we must ensure no one is left behind. Therefore, patient services should be in place to support trial participants in accessing or using new tools in the way which works best for them and their families.

Another concern raised about DCTs is the danger that personal relationships between participants, investigators and study coordinators will be lost. However, embracing technology does not, and should not, mean a loss of the human touch. In fact, it can enhance patient services to make them more personal.

Distribution centers, for example, can help both HCPs and patients get the most out of home visits. Because when the best possible equipment is delivered safely and on time, every time, HCPs have everything they need to provide patients with remarkable experiences in their own homes.

As already discussed, wearables and home-monitoring devices offer the opportunity to capture diversified health data at scale. However, there is a need to guarantee the integrity of this data.

Alongside robust processes and technology solutions, patient-centred trial design is key. We must make sure patients are supported to use monitoring technology correctly and engage with community and patient groups to ensure digital solutions work for all trial participants.

https://ec.europa.eu/health/system/files/2022-02/guidanceclinicaltrials_covid19_en_1.pdf

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Neal Pope

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