Flaskdata Make Clinical Trials Better for Patients and Doctors

Israeli tech startup Flaskdata, which is shaking up the way clinical trials are monitored, has recently presented research showing key insights into the understanding of selective attention which explains why clinical trials and their investigators often miss key issues with the patients participating in clinical trials. According to Selective Attention theory, humans tend to focus on the parts of a situation that are immediately most interesting and ignore the rest of what’s going on. Humans are only able to pay attention to a few things at once, which means they need to be selective. Selective attention is a cognitive process in which a person attends to one or a few sensory inputs while ignoring the other ones.

Selective attention can be likened to the manner by which a bottleneck restricts the flow rate of a fluid. The bottleneck doesn’t allow the fluid to enter into the body of the bottle all at once; rather, it lets the fluid to enter in certain amounts depending on the flow rate, until all of it has entered the bottle’s body. Selective attention is necessary for people to attend consciously to sensory stimuli in such a way that they will not experience sensory overload.

The company compares LA Freeways and clinical trials, by explaining that clinical trials are a lot like watching cars on a freeway. Imagine an observer standing on an overpass over a freeway watching cars that are moving at a fairly uniform pace. After a very short period of time, the observer will generally ignore cars traveling at the same speed. The observer will, however notice slow-moving vehicles or cars speeding and weaving in and out of traffic. The casual observer on the freeway overpass won’t notice that the majority of cars are speeding, bumper to bumper, because the speeding behavior is consistent across most of the cars, and therefor the brain doesn’t consider it to be of note.

In the case of clinical trials, GCP (Good Clinical Practice) requires adhering to the protocol in order to protect patient safety. Continuous protocol compliance monitoring automation can help with this, and, like counting cars, protocol compliance automation is often better than manual monitoring. A study monitor visits investigative sites once every 4-8 weeks and logs deviations. In our freeway paradigm – that is the equivalent to to standing on the same overpass and counting cars at the same time once every 4 weeks which is hardly comparable to using cameras that count license plates continuously 24 hours / day.

As with drivers on LA Freeways, clinical operations teams might be thinking something like “I want to go real fast” and make mistakes or (like drivers) simply act in ways that might jeopardize the safety of the people on the freeway and also make the freeway system less effective. Automation of the monitoring process can help authorities and study managers know to take appropriate action to mitigate risks, leading to more effective freeways and faster, more accurate medical studies. Automated Patient compliance deviation detection and response using the services provided on the flaskdata.io platform for a connected medical device clinical trial is 100X faster than manual monitoring. The company’s services enables clinical researchers to monitor their studies faster and always have an immediate picture of the study. Flaskdata.io customers are conducting medical device studies in the areas of Women’s Reproductive Health, Pain, Chronic Illness, neurology, oncology and recently cannabis.

Study protocol compliance automation for home use medical device clinical trials can run a fraction of the cost of manual site monitoring, in addition to being 100 times faster. Automation eliminates delays due to monitoring, and allows sponsors to get a complete image of what is going on with the study in a matter of minutes instead of a matter of weeks. As a bonus, flaskdata is compliant with HIPPA and GDPR data privacy laws in the US and Europe.