One essential consideration in clinical trial development is whether the trial will represent a given population. The most representative trials use recruitment techniques and advanced statistical modeling to approximate the effect in the real population. Unfortunately, the classic "centralized" clinical trial models--in which study participants come to a study site to complete study tasks or tests--tend to make representation more challenging since these trials systematically prefer study participants willing to visit a study site. The participants who have the time and resources to visit a centralized study location may not represent the targeted population.
"Decentralization" is a counter-movement in the clinical trial community that involves allowing study participants to complete some or all study activities or tests from a distance. Like many shifts during the COVID-19 pandemic, this trend has several clinical research advantages and has continued to gain traction even after medical research centers have reopened.
A decentralized clinical trial (DCTs) is a research trial intended to make study processes more convenient for patients or study participants. This can mean simplifying trial procedures, moving study tasks online to be completed from home, or using Clinicians to complete study specific assessments in the patient’s home. The goal is to improve the patient/participant experience. If it is easier for study participants to complete study procedures or processes, researchers will conduct more clinical trials and obtain more accurate representation in their samples.
Trials may also fall under a "hybrid" definition. They require specific tasks to be completed at the site (i.e., Screening Visits or Visits with assessments such as an MRI) but will incorporate some virtual or mobile components into the study design (i.e., safety assessments/blood draws to be completed in the home by a Clinician).
By reducing the burden on patients, their families, and/or caregivers, your study team will ultimately increase your patient recruitment and retention efforts, allowing your company to achieve their goals faster. In a world where everything is about creating a simpler process for the end user or making almost everything available on demand and delivered to your home in hours, why wouldn’t Clinical Trials adapt to the new norm?
In traditional trials, study directors may need to employ an entire staff team to run study operations in the clinic. Decentralized trials may dramatically reduce the need for logistical support, which contributes to cost savings, simplifies trial operations, and speeds up trial proceedings. Over time, this could enable physicians or researchers to conduct more trials in a shorter period. This increases the number of trials contributing to clinical improvements.
In centralized trials, it is estimated that about 70% of study participants live more than 2 hours from trial sites. Besides being a hassle for recruitment and subject retention, the problem is that the participants willing to commute for study procedures may not reflect the target study population. Decentralization allows for a much broader, more diverse, and potentially more representative pool of prospective participants.
When recruitment approaches or study tasks change in a clinical setting, researchers need to be mindful of which participants they could be systematically excluding. For example, suppose a study aimed at measuring the effects of a particular variable on the elderly population relied exclusively on zoom meetings. In that case, researchers might exclude their target group (or the study design would attract a subset of the elderly patient population that may not reflect true population abilities). For this reason, it is essential to be mindful of study methods, design, and potential bias.
When study subjects carry out study procedures in their homes, it becomes more challenging to eliminate variables that may affect study outcomes (distractions, network connection differences, etc.). Certainly, decentralization is not suitable for every kind of trial for this reason. However, some resources can help mitigate--or at least quantify--the degree of variation. These tools are designed to evaluate the rigor and quality of the research being conducted. Good Clinical Practice Audits fall under this category and should be used whenever possible (especially for researchers working decentralized trials for the first time) to verify the credibility of methods and data.
Most clinical trials will likely migrate toward a “hybrid” model rather than opting to use a fully “decentralized” approach. But even incorporating a limited number of decentralized elements can have significant advantages, including more accurate representation and therefore more practical relevance to clinical research, cost savings, and quicker study data turnaround. By all indications, this is the way research is headed; McKinsey found about a 50% increase in organizations’ interest in incorporating virtual components into trial design.
ProPharma is a leader in clinical research solutions, with services that include decentralized clinical trials. Contact us to find out how can help you determine what visits/studies could benefit from a DCT model. Meet your study goals with ProPharma Group.