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This week I listened as a colleague in Clinical Operations spoke with an EDC vendor. The vendor boasted that lab data, which normally arrives separately from the sites’ patient data, could be integrated with the other site data and viewed as a single-source-of-truth for the clinical team. This got me thinking about what constitutes a single-source-of-truth and what’s required to truly provide oversight of on-going clinical trials.
Certainly viewing lab data alongside other patient data for a trial is valuable. But does that alone illuminate all potential areas of interest for the clinical team and risks for the trial? Perhaps not. What if the Chief Medical Officer wants to compare patients lost to follow up from the last three clinical trials, not just the current trial? How do the rates of site queries compare to trials run with other CROs? Is the vendor-specific view really a single-source-of-truth? Or is it a very nice view into a limited set of data?
Take the picture below. Nice picture. Looks like a beach. We can identify the bird. What are we missing?
What if our vendor-centric view of the seashore takes a little broader view? Our insight expands.
Let’s increase our visibility yet again, this time dramatically. It wasn’t our imagination! This is a flock of gulls on a beach. The data confirms it.
What has our simple analogy shown us? It’s not enough to see the site-entered and lab data together. Holistic clinical trial oversight requires the ability to see the data from all domains and from other trials in the program. This requires a true single-source-of-truth. The requirements of which are pretty clear and straight forward. Clinical study sponsors need end-to-end, real-time visibility to aggregated data from multiple eClinical systems, across multiple domains and potentially multiple CROs. Management of the data streams should be automated and validated, with intelligent AI driven error checks and notifications. Access to the data must be role-based and appropriate for each user community.
Data visibility across diverse domains helps sponsors identify expected and unexpected risks and mitigate them early. Access to an aggregated standardized true single-source-of-truth allows clinical teams to gather insights, monitor performance, assess safety, review compliance, and keep studies on time and within budget.