Contextualized Research – Now Playing!

Contextualized Research – Now Playing!

Clinical research has followed a tried and true approach for many years. "If it ain't broke, don't fix it," they say. Well, we agree: it's not broken — but we do believe that it can be improved upon. To illustrate this new approach, we're using two (admittedly oversimplified) hypothetical case studies. The first is an example of the status quo. The second is a new way of conducting clinical research: what we at THREAD Research call Contextualized Research.

Current state: standard research

A man named George walks down a Southern California boardwalk. He thinks to himself "It's a gorgeous day for jog. I think I'll ..." Just then George clutches his right arm and winces, kneeling down on one knee in extreme pain.

A few weeks earlier, George had enrolled in a clinical trial at the University of California, Irvine. He has struggled with symptoms of anxiety for years. He's tried everything, but nothing seemed to bring relief. His doctor finally recommended a trial drug called Butrax that has been rumored to be the next big thing in anti-anxiety medication. George jumped at the chance to be involved with the trial.

For the first week of the trial George experienced a significant reduction of symptoms. By week two, he was a believer — "Butrax may actually eliminate my symptoms," George thought to himself. As he walked into the trial research clinic for his weekly check up, he smiled to himself knowing that he was going to be receiving another week's supply of the once-daily Butrax. The research staff were pleased to hear of George's positive results and sent him on his way.

It was about two hours later that George found himself hunched over on that boardwalk, clutching his right arm and writhing in pain.

George had experienced a blood clot. He became the 18th patient to experience this adverse affect from the Butrax clinical trial. The researchers, as well as the drug manufacturers, hadn't seen anything like this in the lab and were baffled as to what could be causing this side effect. Butrax was looking like another highly effective drug that was simply not safe enough.

Alternative state: contextualized research

Now, let's look at this story again — but through the lens of a clinical trial augmented by a few of the many mobile research technologies available today.

Let's pick up where we left off — 18 blood clot incidents that have the researchers scratching their heads. They've come up with a few hypotheses as to what could be causing these issues. However, in this scenario, they have the opportunity to test their theories alongside the data their trial participants have been generating via their mobile devices in between weekly visits to the clinic.

The researchers first hypothesize that the blood clots could be related to high altitude. But, thanks to the geolocation data they had on each patient during and around the time of the incidents, they concluded that like George, many of these individuals were at low elevations at the time of their blood clot.

Researchers next thought the cause could be related to a possible blood sugar issue. Each trial participant had been given a wireless glucose monitor, and all 18 blood clots were associated with low blood sugar … yet there were also participants who showed low blood sugar but did NOT have a blood clot. The data also pointed to low blood oxygen levels shared by all 18, which was reported by the wireless pulse oximeter (worn by participants). But again, there were also those with low pulse-ox that did not end up experiencing blood clots.

So what was it then? Were these exceptions just lucky? The researchers could conclude from the data that if your blood sugar and pulse oxygen levels were low, that you were more likely to generate a blood clot. But that insight still didn't help the researchers connect the dots as to why these blood clots were happening.

It wasn't until they realized that prior to each patient's blood clot incident, activity levels had been high for a sustained period. Each participant in the trial wore a smart band with an accelerometer, gyroscope, and heart rate sensor that supplied this data. Finally, the researchers could see the whole picture. Of the 18 incidents, all 18 displayed low blood sugar, low blood oxygen, and had recently participated in rigorous physical activity.

Now that the researchers had this information, they could successfully complete the trial and go to market. The contextualized knowledge gained from the additional data generated by the 18 participants both rescued the trial and informed future drug development and trials.

Is this approach to trials research really possible?

The short answer — yes. All of these technologies are at our fingertips and our belief is that this is the ONLY way that trial research should be done as we move forward. Join us — this work is too important to not leverage the technologies available.