This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG’s expert staff. This month features Steven Beales, senior vice president of scientific and regulatory at WCG.

Question: The current safety reporting process is open to overreporting and mistakes, and this can lead to serious problems for clinical trials and damaged relationships with sites. What is the bare minimum a safety reporting system needs to have to properly track compliance, lessen site burden and account for trials in multiple countries?

Answer: 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 suspected unexpected serious adverse reaction (SUSAR) to a particular investigator. For example, because our technology embeds trackers in our emails, 98 percent of the time we can tell when they arrive 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; and
• 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.

Question: Safety reporting has been identified as an area of inefficiency and hidden fees for sponsors to the tune of millions or tens of millions of dollars spent annually on excessive site payments and monitoring for unneeded safety reporting. How much savings can sponsors that overhaul their safety letter distribution processes realize?

Answer: It requires an upfront investment, but it yields a tremendous return. The return on investment can be around 10-to-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.