The COVID-19 pandemic impacted most sectors of the economy, such that novel interactive methods adopted during the global lockdown are now being adapted post-pandemic lockdown. Businesses and organizations are embracing hybrid work patterns and, in some instances, full remote engagement.

The health and clinical industry is one of the major sectors that adapted quickly; in part, due to the essentiality of the services, and eventually to a surge in new telemedicine practices where the virtual platform became the interface between the clinician, the patient, the clinical sites, and other healthcare providers, as against the traditional clinical setting where all the interaction occurs. Although telemedicine practice has been in existence long before the COVID-19 lockdown in 2020, it saw an acceleration in deployment and use during and after the global lockdown period.

The clinical trial industry was also greatly impacted in 2020, such that it affected quite a number of studies at various stages of the clinical trial processes. However, the challenge became an opportunity to deploy digital interventions that were developmental, now termed Decentralization of Clinical Trials (DCTs), the first of its kind was claimed to have been conducted by Pfizer in 2011, which was 11 years before the COVID-19 global lockdown.

What does DCT mean?

According to releases from the FDA, DCTs could be explained as “the use of digital technologies to remotely conduct clinical trials and communicate with study participants and collect data”. This implies that clinical trials conducted in clinical sites can now be done in off-site locations like the patient’s home, laboratories, pharmacies, or locations around the participant’s dwelling, etc. Traditionally, clinical trials engagement is between the patient-site-sponsor or CRO, while the DCT principle eliminates or minimizes the clinical site, and shifts attention to the patient with data triangulated between the patient, the reporting tool, and the sponsor or CRO.

Also, read SIMPLE AND EASY-TO-UNDERSTAND BASICS OF CLINICAL TRIALS.

DCTs offer quite a number of benefits and opportunities, ranging from maximizing the use of telehealth interventions that will reduce the cost of using a clinical site and associated administrative costs. It increases the likelihood of diversification among participants by reducing geographic barriers for potential study participants. In situations that may require travel in traditional trials, it reduces the need for such movements to study sites, and the related costs, and consequently minimizes disruption of participants’ daily routines and the likelihood of dropout from the study. It is ultimately beneficial for both the participant and the sponsor, and also in trials that require a small population in rare diseases.

Despite the flexibility of DCTs, some contentious views have it that not all types of trials and stages can be conducted with the novel method, especially in an intervention that may require clinical expert judgment on close participant monitoring. An early-phase trial to determine the efficacy and safety of a pharmacological intervention may pose a challenge for the participant, especially in the occurrence of a life-threatening event that could be attributed to the trial product, and the ability of the subject to describe the experienced phenomenon from the product or device under study.

While there could be unpredicted and unanticipated events, DCTs systems are employing the use of sensory and wearable digital technologies to collect vital signs data in real-time, and eReminders to optimize electronic Patient Reported Outcomes (ePRO), which are being built into clinical trials management systems. However, data standards used must meet regulatory requirements, especially with biometric devices and validated quality standards defined for ePROs.

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Since data collected and reported in DCTs is real-time in DCTs which require connectivity to the clinical trial management system, it may require technical support for troubleshooting issues for adequate all-time connectivity. There will still be logistics management support for supplies to the study participants and, in some cases, visits to a nearby affiliated laboratory for investigations and even pharmacokinetic parameter considerations.

DCTs require a critical review and consideration of a wide range of criteria and compelling rationale, matched by adequate systems to ensure attaining the specific objectives of such trials. As sponsors shift attention toward participants-oriented trials, DCTs become the option for consideration. However, should a hybrid trial offer the best option, where incorporating minimal utilization of a clinical site be the best option? Stay connected with us as we take a deeper look into DCTs and their applicability in specific intervention trials.