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There's no one-size-fits-all approach during the COVID-19 pandemic
The COVID-19 pandemic has added significant risk for pharmaceutical and medical device clinical trials by confounding important safety endpoints. Adjudication of clinical events plays a crucial role in ensuring life-improving therapies are developed and brought to market safely, but adjudication programs can be arduous and costly if not managed properly. Today, trial sponsors must be more diligent than ever in their adjudication pursuits while simultaneously grappling with dramatic landscape and procedural shifts caused by the pandemic.
An effective adjudication program, regardless of where it is or who is leading it, depends on how clinical event data is managed. However, there is no one-size-fits-all approach. A widely accepted academic or industry standard pertaining to a Clinical Event Committee (CEC) simply doesn’t exist and there is very little regulatory guidance for trial sponsors. Additionally, some event adjudication is still conducted on paper, which in addition to being extremely time-consuming is error-prone and expensive, creating significant resource burdens for organizations.
These challenges often manifest in clinical trials in the form of incomplete source documents or documents containing unredacted patient health information (PHI), putting sponsors at risk for noncompliance with EU GDPR, HIPAA and other privacy regulations. Problems can also arise from delayed reviews by CEC members or poor visibility into the status of event queries or other performance metrics.
The COVID-19 pandemic has exacerbated these challenges by constraining clinical sites, clinical investigators, and trial participants. This disruption has significantly impacted clinical trial operations—interfering with patient enrollment and recruitment, efficient source data collection, protocol adherence and delivery, outcome reporting and regulatory compliance.
As with many areas of clinical research, innovative new technologies—when combined with deep scientific and medical expertise—can help address these challenges and increase efficiency, data quality and compliance, particularly amid a global pandemic when in-person collaboration and timely problem resolution isn’t always possible.
Compared to paper-based processes and trying to manage complex committee worklists through emails and spreadsheets, web-based adjudication platforms offer many advantages in this new era of remote work. A single, centralized location for everything from source document collection to review, along with AI-enabled redaction capabilities and local translation services, make even the most complex trials manageable from anywhere in the world. Once these benefits are fully realized by trial management teams a return to traditional methods is highly unlikely. Specific advantages enabled by technology that trial sponsors would be wise to embrace moving forward include:
Well-known dissatisfaction with paper and other traditional clinical adjudication processes is unlikely to be tolerated much longer given the availability of these kinds of tools. In today’s world, it is critical that best-in-class, custom research tools are at the fingertips of trial sponsors, CROs and CECs to advance the clinical trial process more effectively than ever before. Performing clinical adjudication via a web-based platform minimizes the risks presented by COVID-19 by alleviating the well-known strain on the various stakeholders, empowering them to finally complete their workflow efficiently, safely, remotely, and securely.
Dan Gebow, PhD, is the Chief Innovation Officer at Bioclinica