Spaulding Clinical Research
525 S. Silverbrook Dr., West Bend
Innovation: Spaulding IQ, a new electrocardiogram platform and device
In the pharmaceutical industry, nearly everyone remembers the 2004 worldwide recall by Merck & Co. Inc. of its arthritis drug, Vioxx due to the drug’s linkage with serious cardiovascular problems including heart attack and stroke. The recall was one of the largest in history.
West Bend-based Spaulding Clinical Research has developed a product to improve drug testing that it hopes will prevent a problem similar to the Vioxx debacle.
According to Dr. Jay Mason, chief medical officer at Spaulding Clinical, nearly every clinical trial is supposed to conduct electrocardiogram (ECG) readings of a subject’s heart during the trial. The quality and accuracy of those readings are crucial to make sure trial drugs are safe for a patient’s heart.
Mason has been instrumental in the design and implementation of Spaulding IQ, a proprietary ECG device platform that utilizes a handheld device and a single-button design and automation to perform the ECG test during a trial.
“What we’ve done is make it virtually impossible to make a mistake in the reading,” Mason said. “Human error is a plague in all clinical research, electrocardiography is a particular problem area because currently there is so much human involvement in collecting the data and sending it where it needs to go. Errors of every kind are almost inevitable. With our new system, we’ve eliminated almost every opportunity for human error.”
According to Mason, 70 percent of drug studies currently do the bare minimum of electrocardiography tests.
“More often then not, they allow a local site investigator to use whatever ECG machine they might have locally. They allow technicians to do the recordings in whatever way he or she might be trained, which could be poorly or not at all.”
The resulting ECG generates an initial report and diagnostic statement which is then manually interpreted by the technician, Mason said.
“The results successfully fulfill a requirement when the drug is submitted to the FDA for approval, but the data is usually useless and in many cases neither the sponsor nor the FDA look at it because they know it’s useless,” Mason said.
This approach is less expensive than having a centralized lab conduct the tests, but Spaulding Clinical plans to offer the Spaulding IQ ECG device at an even lower cost to those doing the clinical testing.
“Our goal is to make this product too irresistible for clinical testing sites,” Mason said. “We’re going to offer the device at or below what the price sponsors are currently paying for less than quality ECG results, and we’re going to be able to generate more accurate, more consistent high quality interpretations and reports.”
Traditional ECG machines take a ten-second recording of the subject’s heart. The Spaulding IQ device takes a five-minute ECG reading, which allows for more accurate diagnosis and the ability to more accurately detect problem areas, Mason said.
The device and the software application that supports the device was designed completely in-house and utilizes state-of-the-art voice print recognition technology to record a subject’s demographics and identity information.
“Right now the device functions completely off Spaulding Clinical’s proprietary technology,” Mason said. “All readings generated through the Spaulding IQ device get sent back to Spaulding Clinical and we generate the reports.”
The additional benefit of the ECG device being linked to a software system is that it eliminates the opportunity for human forgetfulness, Mason said.
The program knows when an ECG reading is supposed to be taken during the clinical trial. If that test isn’t conducted, Spaulding or any other Clinical testing facility will receive a notification, Mason added.
“That’s the way we will be operating initially,” Mason said. “It is conceivable that in the future it will be necessary to release the software and the hardware to other entities. For now though, our goal is for anybody who wants to utilize the Spaulding IQ device in their clinical testing environment, they enter into a contract for the software through Spaulding Clinical. From a centric standpoint we can guarantee that the system is used correctly.”
Spaulding Clinical recently received 510(k) Approval from the Food and Drug Administration to begin commercializing the device in the United States. According to Kevin Geno, vice president of global sales for Spaulding Clinical, the company is already working on similar approvals in other parts of the world and hopes to have all of those in place by the end of the year.
“Our goal is first to provide the device and the ECG interpretation for late stage clinical trials being conducted by biotech companies and pharmaceuticals,” Geno said. “We’re exploring alternative markets for the device as well including non-clinical pharmaceutical, home health care facilities, nursing homes and insurance companies. Our goal is to build a better market for cardiac safety and this device can do that.”
