One of the biggest challenges vexing clinical trial operations, study teams and trial site organizations remains the patient accrual problem: that is, accumulating sufficient numbers of the correct participants/patients for a clinical trial. Previous research reveals that nearly 20% of registered trials are closed or terminated early due to a lack of accrued participants. Moreover, as much as 86% of clinical trials fail to meet recruitment targets within their specified time targets. Consequently, study timelines could be doubling due to these recruitment and accrual problems. Growing competition among sponsors and their contract research organizations (CROs), rapid growth in total studies, ever more focus on precision therapeutics and rare diseases—not to mention complex protocols with extensive eligibility criteria—cause companies to increasingly look at diversifiying how studies even get done, from conducting studies in population centers in places like Brazil and China to exploring novel new technologies to out-maneuver and surpass the growing competitive drug development ecosystem. COVID-19, with a massive shift and emphasis on solving the pandemic crisis, coupled with massive government intervention with the recruitment effort via the ACTIV initiative, only compounds the challenges. Factored into all of this are challenges around patient/participant trust of not only the biopharmaceutical sector but also health and government agencies. The lack of effective forecasting and planning for participant accrual just exponentially worsens and compounds the problem.
Many Solution Categories
To solve patient/participant recruitment and accrual, all sorts of solutions are put forth, from internal pharmaceutical and contract research organization (CRO) recruitment teams to specialized patient recruitment houses to new online portals that promise to attract, engage and offer patients to sponsors. TrialSite has written extensively about various academic medical centers using various technologies to tap into and integrate with electronic health records as a means to improve accrual. Moreover, sponsors and CROs as well as sites increasingly use social networks such as Facebook to advocate for various research studies. In some cases, this method shows results. Other approaches seek to network major research centers for federated patient access. Still, others involve tapping into and leveraging aggregate pharmacy and claims data for smarter maneuvering in this field. A whole new crop of venture capital-backed AI-focused startups attempt to solve this problem at a broader scale, introducing hereto unconceivable intelligence matching participants and studies. Many patients rely on clinical research as a care option movement, where research may increasingly get coupled with care at health systems, hospitals and even clinics.
But despite decades of investment and in many cases innovation, much of the problem remains.
Planning: Pretty Bad Situation
When it comes to planning what the accrual will be for a particular study, or group of studies in a program, the situation looks not good. Whether it be subjective investigator planning to a complete lack of any quantitative evidence to past accrual performance or far-from-complete assessments of what it actually takes in terms of resources to complete a study, the state of planning clinical trials in the industry, despite decades of vendor breakthroughs, for example, still remains weak at best. For example, an estimated 20% to 50% of studies fail to accrue subjects at the site live, and 90% of late-phase clinical trials end up extending recruitment timelines to deal with the low accrual rates.
Another AI-based Solution?
Recently, Advarra, one of the private equity-backed consolidating IRB-based organizations, recently announced a new solution in beta called the Insights Accrual Prediction platform, a next-generation accrual prediction platform made available via the Advarra Insights business intelligence platform. Although this product won’t be ready for release until the date of the next “Insights 2021R3 product release,” it nonetheless represents the next announced tool seeking to solve this incredibly persistent challenge to research.
A new advancement?
According to a recent Advarra press release, this latest tool will focus on the planning and forecasting aspects of research-related accrual. That’s because traditionally sponsors, CROs and sites have had a challenging time in accurately predicting actual patient accrual to a clinical trial prior to activation. After all, if a sponsor could analyze all of their protocols and read planned versus actual accrual numbers, including the effort, time and actual performance, machine learning could be deployed in creating solutions.
Can Academic Medical Centers Transcend ‘Zero-Accruing Protocols’?
According to Sarah Stewart, Assistant Director of Clinical Research at the University of Wisconsin Carbone Cancer Center, “Unfortunately, resources to activate, open, and maintain clinical trials are limited and zero-accruing protocols are all too common.” She continued, “The Insights Accrual Prediction platform has the potential to be extremely valuable in preserving and redirecting precious resources towards successful trials. I look forward to the day when our organization is regularly using the platform to make data-driven decisions to determine which trials to pursue, enabling us to focus on trials that will offer the most opportunity to our cancer patients.”
What does the Insights Accrual Prediction Platform do?
According to Advarra, this solution leverages machine-learning and predictive modeling to better estimate study feasibility and accrual. Built using a proprietary algorithm, the platform enables clinical trial administrators to run hundreds of data points to analyze past accrual rates to inform a more confident decision about which studies to activate, and even predict how many participants each study is likely to enroll.
What technology stack is this new solution a part of?
The Insights Accrual Prediction platform is part of the Advarra Insights business intelligence solution designed to immediately provide data-based answers to complex research questions. By connecting to the customer’s OnCore Enterprise Research System CTMS environment, Advarra Insights syncs data to populate intuitive dashboards and reports that support identifying areas requiring intervention to provide a holistic showcase of an organization’s clinical research portfolio to internal and external leadership.
Call to Action: Advarra and WCG are battling for the minds and business of the clinical operations groups of major academic medical centers. If this platform works well, this could represent a differentiating tool.