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Decentralized trials: Who benefits and how?

Clinical trials are a key driver of innovation in the life sciences field, ensuring the validation and subsequent delivery of novel drugs and treatments. Thus, it is imperative to seek alternative means that would enable the smooth continuation of trials, not just during any globally disruptive events like the Covid-19 pandemic, but for the years to come.

Enter decentralized trials, a novel way to conduct research that utilizes wearable sensors, remote patient monitoring, and digital endpoints, to enable the continuous and contact-free collection of data from participants, while limiting in-person contact.

While we have witnessed a boom in home healthcare, understanding the difference between the different clinical trial models can help you evaluate which approach better suits your research.

Defining traditional, decentralized, and virtual trials

Traditional Clinical Trial

In traditional clinical research, data collection happens ‘on-site’. A site refers to where drugs and therapies are tested on humans, and can be a hospital or a clinic. The data is collected from these sites using available equipment, and entered into a database via an intermediary (a member of the study team or a healthcare professional).

Virtual Trial

A virtual trial is entirely site-less and fully remote, meaning no or extremely limited physical contact between clinicians and patients. Enrolment happens at a distance, and all data is collected remotely and autonomously, either through manual patient entry, or through portable sensors. This model is highly patient-centric, and done entirely through remote monitoring.

Decentralized Trial

A study that moves some or all of the trial participant interventions and prospective data collection outside of the traditional clinical trial sites and into the real world. These studies may use electronic platforms and data sources, mobile technologies, or ship investigational products directly to patients. Decentralized trials do not have to be 100% virtual. They offer the added flexibility needed to enable higher patient inclusion, balancing patient engagement with data integrity.

Decentralized trials may also be described as ‘hybrid’ trials, with some physical sites and some remote locations. These types of trials can maximize patient-centricity by allowing the study participant more flexibility in how she or he participates in the research.

A reduction in participant and site burden

A report by the Tufts Center for the Study of Drug Development (CSDD)[1] revealed that Phase 3 protocols collect an average of 3.6 million data points, a threefold increase in just under a decade. This increase, paired with a rise in eligibility criteria and strict timelines, means additional burden not just for patients, but also for site staff who are tasked with recruitment, participant retention, and data collection and input.

Meanwhile, in a study that looked at the engagement of patients in decentralized trials against traditional ones, the participant retention rate was 89% for the decentralized arm and only 60% for the traditional arm. Remembering scheduled visits, taking time away from their family and work to attend them, and having to visit sites that can be hours away from their homes often make participating in clinical studies a challenge.

If conducted using the right tools, hybrid models can enhance participant engagement and, subsequently, data collection, while making it easier for sites to manage the trial.

References

  1. TUFTS CSDD IMPACT REPORTS

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