There is considerable online discussion about real-world data in clinical trials, virtual trials, digital trials, medical IoT, wearables, AI, machine learning for finding best candidates for treatment and digital therapeutics.   From the EDC vendors’ web sites – everything is perfect in a perfect world. Medidata Rave – for example:

Run Your Entire Study On A Unified, Intelligent Platform, Built On Life Science’s Largest Database.

But what happens when the EDC generates 2011 new erroneous queries?

I’m pretty sure that all the hi-fangled buzzwords don’t mean much at this point.

Why EDC queries are bad

There are 6 reasons why EDC queries are bad:

1.EDC queries push workload deeper and later into the clinical trial process.   Deeper and later creates a traffic jam of work.

2.EDC queries are a vestige of paper processing and do not belong in a modern online transaction processing system. If you are not sure about this – ask yourself if AirBnB, Lufthansa and Booking require you to use queries to fix data entry mistakes.

3. EDC queries are resolved in a separate work-flow from data capture.   This creates a work-flow context switch which slows down the site from fast and accurate data collection.    It’s like driving and texting at the same time.  But the work-flow context switch is even worse with queries – see point 4.

4.EDC queries are often resolved days or weeks after the data capture.   Most people can remember what they did this morning but 3 weeks ago? How is this an effective process.

5.When EDC systems like Rave generate large numbers of erroneous automated queries – Moonshine is called for.

6.When we look at the number of automated EDC queries generated by edit checks versus discrepancy notes generated by study monitors we see that there are perhaps 500-1000X more automated queries than the high-value notes generated by a CRA.    This is bad.    The high-quality signals from the CRA get lost in the noise of automated EDC queries.

3 things we can do to improve study productivity

1.Turn off automated EDC queries completely

2.Resolve data issues during data entry. Don’t delay resolution more than a work-day.

3. Trace your query close rate. With a small number of high value notes from the CRA – you can do it on your fingers.