Better Cardiac Safety Trials

Harold Strandquist

The process of collecting cardiac safety electrocardiogram (ECG) data in clinical trials is stuck in the past. Too often, site personnel must rely on bulky ECG machines that collect results and submit them in batches, manage paper records, and perform manual data selection. All this creates roadblocks and opens the door to human error and the kinds of site queries that grind progress to a halt. This often happens because legacy core labs are heavily invested in technologies that are less than efficient when it comes to managing and sharing results. This creates a lack of integration and subsequent inefficiencies. Trial sponsors may still get the results they need, but it is often a time—and labor—intensive process for research personnel.

Fortunately, there is a better way to work. Modern technology can empower site personnel to cut errors, reduce queries, and work more efficiently. Why does that matter? Because research has repeatedly shown that happy workers are more productive. For research site personnel, that may mean they’re more likely to go the extra mile—collect more accurate data, enroll more participants, and provide better information. Here are four factors to consider as you evaluate technology and partners for your next cardiac safety trial:

1. Integration is key. In the typical clinical trial, site personnel enter patient information at each visit. Mistyping a patient’s ID number or incorrectly noting which visit the patient is making requires core lab employees to verify that information, potentially leading to hours or days of back-and-forth calls or emails. Technology that integrates visit schedules, subject demographics, and ECG acquisition data; however, allows site personnel to collect demographic information only once. From there, the system can track which visit a patient is making and connect their data to the proper ID. This level of integration enables the collection of up-to-the-minute enrollment visit data, while providing customizable reports directly to partner systems. And, most importantly, it reduces the potential for human error.
2. Centralize everything. With a centralized system, by contrast, everything is stored electronically, so reviewing an anomaly is as easy as logging in. Ideally, ECG systems will offer role-based access to data, so everyone can view the information they need regardless of location. Centralized data also allows for immediate ECG review and confirmation, ensuring ECG quality and compliance for sites and enabling decisions on inclusion in near real time. In addition, because data changes hands less often, higher levels of security can be maintained.
3. Automation drives compliance. Although ECG research is highly technical, the actual data collection process is often manual. Site personnel get patients settled, wait for them to calm down, then hit a button to collect a resting ECG. But if the patient moves in the instant the button is pressed, the signal can get scrambled and the process starts over. That’s inconvenient for site staff and participants, and it means there will be multiple ECGs for that patient in the buffer, requiring the core lab to verify which data to submit. By contrast, algorithm-based tools allow sites to record up to 20 minutes of ECG data, then either select the best 10 seconds or allow the computer to choose for them.
4. Don’t waste space. Traditional ECG machines aren’t just inefficient in the way they collect and transmit data. At a time when ECG technology is showing up in watches and necklaces, the devices used in most cardiac safety trials are anything but wearable. A reliance on physical records means machines need to be large enough to include a printer, and paper feed. As a result, machines are bulky, and a site that manages multiple trials can quickly fill closets with equipment dedicated to various sponsors. More sophisticated options, meanwhile, connect ECG leads to powerful tablet computers to collect data. The touch screens put information at users’ fingertips, while modern computing tools offer advanced capabilities in a compact package that is easier to carry and store.

Advances in ECG acquisition technology improve speed, accuracy, compliance, and data security. Working with digital data throughout the process ensures information won’t be recorded under the wrong name, or that paper records won’t be accidentally filed in the wrong place. It’s a defense against human error, in other words. In the long run, that means research sponsors can reduce queries and help research sites achieve better results, in less time, and with significantly less frustration.

Harold Strandquist, President, HeartcoR Solutions