Unsustainable and Burdensome: Today’s Safety Reporting Fails Sites, Sponsors and Patients

The way most sponsors and CROs approach safety reporting overburdens sites. Sponsors bombard sites with safety notifications, many of them unnecessary. Sites are overwhelmed to the point they may miss the critical patient-safety information. 
 
Safety reporting is one of the last areas of hidden cost and inefficiency in clinical trials today, costing sponsors millions or tens of millions of dollars each year in excessive site payments and monitoring costs on unnecessary or duplicate safety reporting. Few receive value for their investment, and some don’t even know how much that investment is.
 
The entire process is also prone to error and over-reporting, burying important new safety information and putting patients at risk. Moreover, one mistake can lead to regulatory repercussions, delays—even having a trial go into rescue or be shut down. Even if the trial remains unaffected, sites are disinclined to work again with sponsors who bombard them with superfluous, burdensome paperwork. Given the fierce competition for top-tier sites, no sponsor can risk alienating them.
 

Exponential Effect


A single incident can generate many notifications. For a large pharmaceutical company or CRO, the scale is enormous—with tens of thousands of notifications being distributed every day to dozens of countries. Each country may have its own rules and regulations. 
 
Consider: A SUSAR (Suspected Unexpected Serious Adverse Reaction) letter must go out, typically within 15 days after the sponsor is notified of the event. At the largest pharma or CRO scale, they have to send out, or attempt to, 25 million to 50 million letters or notifications each year. To put that into context, that’s over 75,000 a day. It’s relentless.
 
All this must be auditable. Sponsors must be able to show that the notification was sent to the right person, that they received it and, in some cases, even that they acknowledged and understood it. 
 

More is Not Better


In the past, sponsors would typically fax letters or use an overnight service. It was inefficient and often expensive, with no assurance the notifications were actually received.  Some sponsors still do, but most have moved moving toward automated approaches—at a minimum, email. 
 
This allows sponsors to easily send out more safety letters, but that creates a new set of problems. The attitude seems to be “Well, if I send too many notifications, that’s not going to be a problem, is it?”
 
It is a problem. Too many notifications end up burying important safety information in a pile of unnecessary documents.
 
The logic behind this scattershot approach does make sense, to a point. Sponsors’ safety reporting systems don’t accommodate the regulatory variations among countries. To avoid non-compliance, they move in the opposite direction and overdistribute. But really, it’s just as bad: It’s still not compliant.
 
It’s difficult enough to follow a complicated protocol, but then to have unnecessary work on top of it—that’s unsustainable. The IRBs, site staff and the investigator need to evaluate these reports to determine the need for protocol revision, informed consent modifications—even whether the trial should continue at all. But overdistribution makes it more difficult.
 

A Broken System


Clearly, the safety-letter distribution process needs substantial changes to overcome these issues. That requires an upfront investment, but it yields a tremendous return. The ROI can be around 10:1, but it’s all future dollars, and it takes work to realize those savings. Moreover, we’ve discovered that many sponsors don’t have a baseline: They can’t envision how much they will save, because they don’t know how much they are spending. 
 
Because so many sponsors negotiate budgets study by study, they aren’t quite sure how much safety distribution should—or does—cost. We’ve seen sponsors spend anywhere from $100,000 to $2 million per year on one study. One reason the costs remain hidden is that a sponsor will often hire a third party to take it off their hands. 
 
Until sponsors see the actual cost, they aren’t inclined to invest in a solution. 
 
We run into this all the time. We worked with one sponsor for almost a year and go through their budgets with them and uncover what they were actually spending because they couldn't figure it out for themselves. It had become that hidden within their budgets. 
 
 At a minimum, a safety-reporting system needs to include the following:
 
  • Trackability
    Sponsors rarely have a way of knowing that all the appropriate documents were sent to all the appropriate parties. So when an inspection or investigation occurs, they discover that the notifications were never received. Or perhaps, more accurately, they discover they cannot verify receipt, which is essentially the same thing for audit purposes. Before working with us, one client was underreporting events by 2 million cases. To adequately monitor compliance, sponsors need to be able to track a particular SUSAR to a particular investigator. For example, because our technology embeds trackers in our emails, 98% percent of the time we can tell when it arrives in an investigator’s mailbox. Sponsors have complete transparency, which instills confidence. They can click a button and see how many investigators and sites are compliant, when they last logged on and who hasn’t acknowledged what.
     
  • User-friendly Investigator interface
    For the investigator, you want the user experience to be simple. Investigators need to focus their time on research, not on trying to access the dashboard. 

    The simplicity of the site interface is only part of it. Let’s say a sponsor has 10 studies in one therapeutic area. SUSAR distributions occur at the compound level. That means the same SUSAR goes to 10 separate studies—each study using that compound. In a conventional system, an investigator working on three of those 10 studies receives the same document three times and must acknowledge it each time. 

    Ideally, you want the investigator to get the document once, acknowledge it once, and receive credit for all the studies they’re working on. 
     
  • Automation that reduces human error
    The right safety reporting solution reduces human error by eliminating manual data entry. Data-entry errors are common in our industry. You want a safety reporting solution that will integrate with and pull information from clinical trial management systems, safety databases, trial master files, shared investigator platforms, etc.
     
  • Functionality that improves patient care
    Eliminating unnecessary notifications has a direct impact on patient care. First, consider the hours each site would save every week. That’s time they can spend with their patients. Perhaps more important, sites can better ensure patient safety. Sites are supposed to use SUSARs to talk with their patients and check for the symptoms described. When sites receive only the relevant and important notices, they can do this. When sites are being flooded with information, they may miss a crucial alert, putting patients at risk.
     
  • Provide global harmonization
    In large trials, sponsors must keep up with hundreds of evolving country-specific rules. Any safety-letter distribution solution must allow sponsors to distribute SUSARs based on each country’s requirements. 
 

Moving forward


The current approach to safety reporting is costly and inefficient, burdening sites, frustrating investigators and putting trials in jeopardy. Worst of all, it puts patient safety at risk. It’s time for a change.
 
WCG’s Safety Reporting Solutions help clients improve safety, efficiency and compliance while saving millions. It’s time to meet the challenge of global safety reporting.

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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