People are the most passionate about things they are uncertain about.
They don’t argue about the sun setting or rising.
Zen and the Art of Motorcycle maintenance
I thought about buzz-words last night. My wife is now a compulsive news watcher. Personally — it bothers me from getting productive work done at our clinical data startup flaskdata.io — accelerating clinical trials for Corona treatments and vaccines.
The node package manager was just acquired by Github — the announcement was made yesterday. This is an amazing tribute to the power of simplicity.
If you’re a software engineer, you probably heard about Node.JS. In the Node.JS world you have the node package manager NPM with over 1 million packages. Free, infinite variety for the price of 1 buzzword. No one is passionate about Node Package Manager. It just works.
There are too many buzz-words in clinical research. EDC, ePRO, eCOA,IRT, IxRS, eSource, eConsent, CTMS, CDM, SDTM, eClinical and more.
It seems to me as long as there are 763 clinical software vendors and 1000 CRO professional service providers to clinical trials — we will continue to wage the war of buzz-words.
Buzz-word proliferation will not bring a Corona vaccine faster to market.
There are a multitude of challenges in clinical research, but the most significant is the delays in the completion of clinical trials. 12–18 month delays of Phase 3 trial completion are delays of therapeutics for patients. The 2020 COVID-19 pandemic and the emergence of the G614 mutation of SARS-COV-2 makes time-to-market a life-and-death question for all of us.
These delays are due to variability in data which are in turn caused by variability in procedural adherence and verified data collected by research sites. This is a problem amenable to solution by technology. Meaningful delay reduction cannot be achieved by CRO outsourcing services.
The current rage is digital health and decentralized, patient-centric trials. Unfortunately, decentralized trials just shift the data quality and clinical outcome challenge to an even more-uncontrolled environment of patients at home using unmanaged devices.
Let’s simplify not complexify the technology starting with trashing the buzz-words.
All we need is 3: Collect, Detect and Act. Collect clinical data from any source. Detect — automate detection of anomalies. Act — automate response with a message or Web hook to the right person or app.
There. That wasn’t so complicated. Was it?