Spaulding Clinical Becomes World’s Largest Telemetry Provider

Exciting times! Today it has been announced, that the company I work for, has become the largest provider of of telemetry monitoring for a Phase 1 research unit.

Why are ECGs in clinical trials important?  What are the other guys doing to collect ECGs?  What is telemetry, and why does the fact that we're the world's largest provider of it make us special?

First, as mentioned before, an ECG is a measurement of heart activity.  From Wikipedia:

.... interpretation of the electrical activity of the heart over time captured and externally recorded by skin electrodes.

Collecting ECGs in clinical trials is important for two reasons: a) immediate safety of subjects during the trial and b) it measures cardiac changes as a result of receiving a drug; this change could impact long-term safety.  The change that everyone looks out for is what is called QT prolongation.  QT prolongation can lead to some nasty things if not properly addressed.  You may remember a few drugs being pulled from the market over the years for this exact cause.  Don't worry, the FDA's got your back...  From the FDA (E 14 Guidelines),

"Drugs are expected to receive a clinical electrocardiographic evaluation, beginning early in clinical development, typically including a single trial dedicated to evaluating their effect on cardiac repolarization (“thorough QT/QTc study”). "

Ok, if it's important to collect ECGs in clinical trials because it helps keep people safe, what are other research units using to collect ECGs?  Typically, there are two methods of ECG acquisition employed: electrocardiographs (I mentioned what that is in a previous blog post) and Holter recorders.  While Holter recorders definitely have an advantage over electrocardiographs, both are less than optimal when it comes to drug research.  With traditional electrocardiographs, clinical personnel roll up to a subject with a giant machine on wheels, they have to enter in a bunch of data using tiny keys, they then have to hook the subject up to electrodes, and finally they click 'print' to get a paper version of ten seconds of ECG data.  Lots of opportunities for error, lots of action in getting the subject ready.  With all of that commotion, there are definitely going to be effects on the heart.  With Holter recorders, you have to program the device to specify who you're collecting data from, you start recording, and then you forget about it for a while.  You hook subjects up once, and you can collect A LOT of ECG data.  When the collection period is over, the ECG data corresponding to the proper time-points is extracted from flash memory cards (just like in your digital cameras).  A couple of problems here though:

• If there is some sort of impedance to collecting the data, you're not going to know it until the data is analyzed.
• Cardiologists aren't going to be able to review the data in real time - if there are immediate safety issues, it's going to take a bit to have that known.
• Extracting the proper time-points one by one is cumbersome and introduces opportunities for error.  In a recent study, we had 256 subjects where  approximately10 ECGs were collected each day over 8 days: yeah, that's over 20,000 ECGs!

Ok, old_school_cardiographs = bad, Holters = (not as) bad.  What about telemetry, what makes telemetry good?  Telemetry (according to Wikipedia), " ... is a technology that allows remote measurement and reporting of information".  Think of the TV show ER: in the background of most hospital scenes, you get to see some squiggly green lines, and hear some beeping.  While although, I don't know for sure if that is telemetry, that's the same idea; you're seeing cardiac data as it is being collected.  The big bonus with telemetry is that people get to see how things are working in real time! You can collect the same amount (and more) data as Holters, but all necessary parties know what is happening.  That obviously leads to higher quality.

Here's the software part: by integrating with the telemetry system, Spaulding Clinical has developed a system that really keeps the focus on the subjects in the trial.  By leveraging an interface we've named SCi ECG (I indirectly blogged about this a few years back), clinical personnel focus on making sure subjects lay still at the specified times when an ECG must be acquired.  With clinical trials, timing is important.  Regulatory bodies mandate that ECGs are taken at very precise times... typically relative to a dosing time.  With this interface, personnel don't have to do anything other than ensure that the subjects are all very still, the automation does the rest.

Spaulding Clinical's automated and integrated telemetry model means no transcription, no rushing around with giant carts, no blindly hoping the Holter recorders are still recording, no big variables.  And donchaknow, less variability is better science.  Better science leads to safer drugs!