New Normal or Not, Safety Reporting Matters

July 9, 2020 Steven Beales
Even during normal times, the usual approach to safety reporting places a heavy burden on sites. Sponsors inundate them with safety notifications, many of which are unnecessary. As a result, sites become overwhelmed and miss critical patient safety information, which become lost in a mountain of paperwork that includes unnecessary notices. Moreover, this practice is contrary to health authority and country-level rules and regulations. 
 
Once you overlay these issues with the current pandemic-driven uncertainty and staff shortages, the depth and breadth of the challenge becomes apparent.
 
And while it’s true that the Food and Drug Administration and other regulatory bodies are loosening up certain requirements during the pandemic, they are allowing no slack in the reporting of unexpected safety events. Suspected Unexpected Serious Adverse Reactions (SUSAR) letters still must go out, generally within 15 days after the sponsor is notified of the event – seven days in case of death or a life-threatening issue. 
 

A Failed Status Quo


Each year the number of clinical trial safety events climbs, prompting more companies to seek ways to reduce their spending on safety. No company wants to reduce safety—but organizations do want to streamline safety reporting. They want to be compliant but spend less, if possible. Patient health is first and foremost, but far from the only reason to maximize safety. One mistake can lead to penalties, costly delays, or shuttering trials completely. Moreover, regulations change continuously, adding to the complexity. 
 

The Right Document, the Right Person, the Right Time


Sites and sponsors are grappling with unforeseen challenges. Still, as trials continue, prompt, accurate safety reporting must also proceed uninterrupted. 
 
WCG’s SafetyPortal provides a single path forward. It streamlines safety report distribution and ensures that only those who need to see specific documents receive them. This process enhances efficiency, reduces expenses, and relieves site burden. It allows you to carefully target distribution, giving each site what it needs to comply. When sites receive only relevant notices, they can address safety issues with patients better and more quickly. 
 
To date, the SafetyPortal platform has distributed more than 200 million safety reports and supported more than 7,500 studies. It dynamically tracks changing regulations in more than 110 countries worldwide. 
 

Support in a Post-COVID World


With the shift to remote monitoring during the COVID-19 pandemic, SafetyPortal makes more sense than ever, because it enables remote monitoring of SUSARs. The portal allows sponsors from anywhere in the world to get the right document to the right person at the right time—to any site in the world. 
 
The new normal we find ourselves in has made this capability even more vital because the alternatives less realistic. Prior to the pandemic, we were seeing increased interest in safety monitoring, which corresponded with a renewed regulatory emphasis. This interest has increased in the face of a future that will include more remote trials, less monitoring, and greater reliance on digital tools. Regulatory agencies are placing increasing emphasis on electronic reporting to ensure accurate and complete patient safety data exchange.
 
At the same time, sponsors and clinical research organizations are significantly lowering their expected earnings for the year. When companies start preserving cash, they tend to shy away from new initiatives, and instead focus on existing projects in an effort to streamline operations.
 
We’re seeing a convergence of these factors:
  • A reluctance—or inability—to make large capital expenditures
  • A need to streamline existing operations
  • A COVID-driven trend toward more remote trials
  • Understaffed and overwhelmed trial sites
  • A regulatory push for electronic reporting
Safety Reporting as a Service addresses each one of these trends. It offers most of the same benefits without requiring a new capital investment during uncertain times. And whether implemented as a service or as a fully installed software solution, WCG’s SafetyPortal relieves the burden on sites and patients.  
 

Lifting Site Burden: Streamline for Simplicity 


WCG’s SafetyPortal can help streamline site burden. Let’s say an organization is conducting eight studies in a particular therapeutic area. SUSAR distributions occur at the drug compound level, meaning the same SUSAR could be delivered to eight separate study sites—since each study is evaluating that compound. 
 
With a traditional system, an investigator working on three of those eight studies receives the same document three times and must acknowledge it each time. This drowns the site in unnecessary emails, burying important safety information in a pile of noisy, irrelevant documents.

It also increases the likelihood of human error. Data entry errors are common in the clinical trials industry. SafetyPortal offers an entirely automated process, based WCG’s integration capabilities with clinical trial management systems, safety databases, trial master files, shared investigator platforms, and the like.
 

Improving Patient-Centricity


The pandemic has impacted significant portions of the clinical trials industry, but one trend that didn’t slow was the move toward patient-centered trials. Reducing site burden improves patient care. When sites are flooded with information, there is a greater chance that they will miss important safety alerts.
 
However, when sites receive only relevant and important notices, they end up spending more time with patients—which allows them to address actual safety issues with them. 
 

Moving Forward


The pandemic will be a catalyst for significant change, but no one knows exactly what those changes will be. We can expect more virtualized trials, as well as a move away from on-site, regular visits by monitors. 
 
SafetyPortal is one of the technologies that helps to support that transition—a transition we see as permanent. If you’d like to learn more about what’s involved, visit us at  https://www.wcgclinical.com/services/safety-portal/.

About the Author

Steven Beales

An expert in the field of safety reporting technology, Mr. Beales has 25 years of experience in IT, and has spent over 16 years in the pharmaceutical industry. He joined WCG ePharmaSolutions in 2009 and led implementation of the company’s Clinical Trial Portal at Genentech across 100+ countries. In 2015, he led implementation of the Clinical Trial Safety Portal at a top 5 pharma organization, which included a data-driven rules engine configured with safety regulations from those countries, which saved this organization hundreds of millions of dollars. Over 50 million safety alerts have been distributed by these two portals via the cloud. Prior to joining WCG ePharmaSolutions, Mr. Beales was the Chief Software Architect at mdlogix, where he led the implementation of the CTMS systems for Johns Hopkins University, Washington University at St. Louis, the University of Pittsburgh, and the Interactive Autism Network for Autism Speaks.

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