Enhancing Patient Engagement with DCTs

It is always important to remember that clinical studies are not merely a laboratory experiment to validate or disprove hypotheses; rather, they are a human experience that must be delivered with care, and sometimes a last line of treatment that must be offered with compassion. This is often forgotten among the other important priorities of trial design, but it is key to maintaining high patient engagement, both with regards to recruitment, retention and activity levels – which are essential for the success of a clinical investigation. Decentralized Trials, and the digital technology they bring with them, can offer many advantages in that area. 

The meaning of Decentralization

Decentralized Clinical Trials (DCT) refers to the broad area of the industry that works to shift the focus of a trial from centralized facilities to patients themselves instead. This is typically achieved using new technology, particularly digital and remote health solutions. Trials may be fully or partially decentralized – either would fall under the DCT term. DCTs promise to increase patient engagement by making trials more accessible and convenient – though they face their own hurdles in doing so.

While DCTs and the technology that underpins them have been accessible for over a decade, the spotlight was shone upon them with the COVID-19 pandemic; the social distancing guidance and safety regulations imposed to counter the virus had a profound impact on traditional clinical trials. This led to increased adoption of virtual elements – nearly three times as many trials were using decentralization technologies after the onset of the pandemic than were before. 

Strengthening Recruitment

While DCTs experienced a significant upshot with the pandemic, this upward trend is projected to continue – particularly as the technology they use has made evident their potential to increase patient recruitment, retention and engagement. They offer particular advantages in enhancing recruitment pools; a meta-analysis of barriers for participation in oncology trials showed that concerns with trial settings and discomfort with the research process were two of the biggest reasons cited for non-participation. 

These barriers can be generalized to other therapeutic areas – but one of the primary reasons that recruitment can be unattractive is the cost. Patients often have to go out-of-pocket for site visits in traditional trials, which tend to be conducted in central urban facilities. Reducing the number of visits by using novel technologies such as eConsent, web-based questionnaires, oximeters, telemedicine and even other smart digital tech can dramatically reduce the financial, but also temporal, burden placed on trial participants. This not only makes recruitment more attractive, but it also opens up a more diverse pool of participants – something that is sorely needed for future studies. 

Reducing costs can attract poorer patients that may not be as flexible with work and family duties, residents of more rural areas that may not normally want to travel regularly to wherever central trial sites are, and the list goes on. An analysis on patient-centric trials by the Economist found that trials using DCT approaches took just over half the time to recruit participants (4 months) compared to traditional trials (7 months), while also being likelier to launch – 87% for the former, versus 68% for the latter, indicating the recruitment boost that virtual trial technology can provide.

Improving Retention

Recruitment is often the biggest predictor for patient retention in clinical trials. Beyond that, DCT technology can enhance retention rates by improving upon various areas, in more cost-efficient ways than traditional trials do. Human engagement is often cited as a drop-out reason for patients, particularly in longer trials – perceiving staff to be uninterested or having to interact with new staff on a regular basis can undermine retention. Virtual technology can make staff more easily available through remote communication tools, rather than having support staff available across multiple sites, and it can also reduce the cost of staff-to-patient interactions, enabling providers to increase such engagements. A continuous stream of communication through the use of technology can also flag other issues – whether they be personal, physiological or otherwise – for healthcare professionals before they can cause the patient to drop out of a trial.

Direct-to-Patient

An area of particular focus in trial decentralization has been the delivery of investigational medicinal products to patients, frequently shortened to direct-to-patient. This can dramatically lower the need for site visits – but brings added complexities to any clinical trial, such as the need for organized supply chains that can handle distribution to patient homes. The advantages it brings with it can make it worthwhile however; if clinical trial sites no longer need to function as distribution centers they can be freed up for other functions that can better improve patient retention. This is particularly important for longer trials, where retention can be increased if travel to sites for drug distribution is not required for years on end.

However, there are multiple concerns that are much harder to tackle with direct-to-patient; products in early trials with safety profiles that are not well understood may not be particularly suitable for the model. This is because these products will require significantly more detailed study and observation to better comprehend their possible adverse effects and reactions.

Though the area of DCTs has only been gaining true traction since the pandemic highlighted its potential to accelerate clinical research, it is a field worth exploring for any clinical developer. Embracing new technologies to bring patients higher in the order of priority for clinical trials has been shown to markedly improve diversity, recruitment and retention – this is done directly, through new and improved methods for communication and surveillance. But it is also done indirectly, through cost-efficiencies that DCT approaches can bring to the table when correctly implemented, freeing up resources to support trials in other ways that can improve patient engagement. 

Cross-industrial collaboration will remain critical as each provider navigates the possibilities of DCTs for their own purposes. Join Proventa International’s Clinical Operations and Clinical Supply Chain Strategy Meetings in Boston in 2022 to hear more about the latest developments in the area, as well as meet key stakeholders that can help kick-start your own journey in DCTs.