Don't hoard it - Put it to use!
The gist of the conference sessions and the keynotes can be summed up in the title of this blog – it’s all about data. Just look at the topics for Tuesday's sessions:
• Wearables and Sensors as Data Sources - DATA!
• Real World Data to support regulatory decisions - DATA!
• Biomarker Driven Trials - Definitely DATA!
This year marked a first for us to observe a number of analytics vendors involved from the healthcare universe. (For an indepth analysis of the reasons behind this trend, download our webinar by clicking here). We’re seeing a new drive for getting to data faster and extracting meaning from vast pools of healthcare data in the health care industry.
We saw some really cool AI apps almost all targeting Real World Data. One in particular purported to use existing data from health claims and EMR/ EHRs to construct virtual control arms for studies. The art is in extracting disease states based on patient charts as well as coded data, fertile ground for a lot of technology R&D.
Several of the attendees with deep experience in clinical trial design joined the demonstrations, and all were cautiously excited. This is because there is still a lot to do and these products still need to mature. The biggest weakness for all of them is the lack of a comprehensive body of Real World Data history within which AI can work.
The good news for that challenge may have come from the previous week’s event at HIMSS and the CMS & ONC rule drop on mandates to EMR/ EHR vendors to open up the silos, and in some cases, stop data blocking. The HL7 Standards body was all elated as CMS/ ONC had chosen their FHIR standard as the de facto standard for data sharing purposes. See HL7 Standards here. The prospect of opening up all these data silos to interoperability with analytic as well as eClinical tools is only good news for domestically conducted clinical trials but leaves all international studies out in the cold. So more work still needs to get done there before we can realize the true benefits.
So what does all this mean to the Clinical Ops Executives?
It tells me that the two universes of healthcare informatics and clinical trial platforms are colliding, and fast. In the past, working with a single eClinical vendor would permit us to tie their systems together. Today, we need to think about tying other 3rd party tools (sometimes their competitors) and data sources to have meaningful results. The proof is in the giant CRO’s joining with lab companies so that they can inject all that lab data into clinical trials operations (IQVIA and Covance come to mind) but that is not enough. We now see real-time streams of patient data from EMR/ EHRs need be combined as well with all the other sources for some of the more ambitious goals that we have set for ourselves.
About Adaptive Clinical
Progressive Clinical Ops Executives are leaving their clinical comfort zones and venturing out into technology and above all planning for a sound interoperability strategy that is based on simple, easy to use and proven platforms.