The pharmaceutical industry is continuing to evaluate and evolve the strategies and tools utilized to conduct Decentralized Clinical Trials (DCT). These strategies have understandably focused primarily on tools to connect patients to study sites; however, an often overlooked DCT tactic involves leveraging pharmaceutical virtual meeting technology to effectively connect CRAs and sites with virtual monitoring visits.

 

Why should DCT be pursued?

The COVID-driven boom in Decentralized Clinical Trials (DCT) leveled off in 2023, as initial experiences are being assessed across the pharmaceutical industry. As we review DCT post-COVID, perhaps the first issue to re-visit is; why should DCT be pursued. Merits of DCT include patient-centricity and sustainability, as well as introducing new ways to collect patient health data. However, the most compelling merit of DCT is the potential to expand the population of patients who can participate. After all, patient recruitment remains the most important and elusive challenge in clinical trials. This is especially true if one defines DCT as “enabling patients to participate without traveling to the study site as often.” The simple math is that, if the distance of potential patients from the study site is doubled, the geographic area is quadrupled, as in Patient Area = Distance². Hence, if the distance increases by three, then the geographic area increases by nine, etc.

However, geographic coverage can be expanded simply by increasing the number of study sites. So why DCT? Because adding study sites is very expensive. Each site requires contracting, start-up, ethical review, staffing, training, monitoring, supplies, shipping, eClinical systems, etc. If a study can be performed by 20 sites instead of 80, savings for the overall study budget can be 15% to 20% or more. Given the continuing spiral of costs of clinical trials, cost savings of this magnitude trump all other considerations.

 

Concerns with DCT

In theory, DCT can be a cost game-changer, but questions remain. Are patients ready to participate virtually, without meeting regularly with investigators? And likewise, are investigators ready? Are there new risks or compromises stemming from DCT? Are patients less invested and more likely to discontinue over a multi-year trial? These concerns and others are legitimate issues of DCT that drug developers must explore.

Perhaps the key question is, does DCT really lower costs? Most DCT tactics involve additional technologies and services, adding yet more complexity to trials. The increased costs of these DCT elements must be offset by enough additional patients per site, resulting in sufficiently fewer sites, to generate overall cost savings. If not, DCT will fail to deliver on its cost-saving promise, undermining its core rationale.

 

Rational Assessment

Today the majority of pharmaceutical developers are selectively using elements of DCT in hybrid trials, as opposed to going all-in on 100% virtual trials. This allows trial sponsors to assess the practicality and performance of individual DCT tactics. It’s an exciting period, and time will tell which tactics demonstrate value.

An overlooked area of opportunity in DCT is virtual site monitoring visits. At MedPoint Digital, we refer to this as “virtual monitoring” because the emphasis is on live virtual visits by CRAs with study sites. This differs from “remote monitoring” which usually refers to 24/7 analysis of data flowing from the site to the monitor. MedPoint Digital pioneered live virtual meetings for the pharma industry and today we deploy an advanced platform that outperforms standard Zoom or Microsoft Teams. Our virtual monitoring platform, InSite Virtual®, features enhanced collaboration tools such as forms, checklists, eSignatures, document mark-up, etc., as well as validated data capture and automated site visit reports. This superior platform for live virtual pharmaceutical meetings is specifically configured to support CRA site visits and offers major advantages in cost savings, quality, and productivity.

 

DCT has turned the corner from a COVID-inspired boom to a phase of rational assessment and sensible deployment. Virtual pharmaceutical meetings, whether for patients, CRAs, or others, have tremendous potential for DCT, but only if they deliver productive, personal experiences that preserve trial quality and data integrity.

 

To learn more about MedPoint Digital’s virtual meeting platform, Elevation, or our virtual site monitoring platform, InSite Virtual, contact us today!

 

About MedPoint Digital, Inc.

MedPoint Digital, Inc. partners with biopharma companies to deploy virtual pharmaceutical meetings and advanced portals that produce unique value. Our goals are to lower costs, improve quality and expedite timelines with digital platforms that transform key areas of clinical operations, commercial objectives, and study site tasks.