In my post Putting lipstick on a pig of eCRF I noted that good online systems do not use paper paradigms. In this post – I will develop the idea of using digital / mobile /automation to become an insights-driven clinical operations manager.
Insights-driven clinical operations practices are more important than ever if you want to operate a global multi-center medical device trial with speed at scale.
I’ll show you how the democratization of data insights with a comprehensive patient compliance monitoring (PCM) platform can help you improve:
1.Medtech Developer and clinical trial operations productivit
2.Site coordinator experiences
3.Treatment and patient reported outcome compliance
Democratization of data insights
In the old world of legacy clinical operations, you waited for site monitoring visits to get feedback on deviations. Remote monitoring and modern EDC systems have enabled us to take a big step forward, although it seems that CRO central monitoring activities move the analytics and deviation detection and response further away from the site operations team and sponsor project manager. Central monitoring for clinical trials is like the old Soviet central planning committees. The exact opposite of democratization. Medidata purchased Shyft Analytics last year. The Shyft platform combines different data sources and a data preparation pipeline of data cleaning, data transformation, normalization, metadata. The idea as I understand it, is to use both clinical trial and real-world commercial data to share data and insights in pharma clinical development and commercial teams. It seems that the system is not appropriate for neither medtech developers nor site operations teams.
Shyft Analytics is a beautiful example of democratization of data insights inside a pharmaceutical company but it is several levels removed from site clinical operations.
Medtech Developer and clinical trial operations productivity
The medtech engineering teams are often bit actors in the medical device clinical trial. For connected devices, this is a mistake in our experience. A connected medical device, software medical device app or home device uses APIs to external systems (which may fail) and embedded hardware and software (which may fail). Feedback from the sites in real-time to the device engineers will help fix issues and improve availability and performance of the device or enable swapping out faulty devices.
Here is a screen shot from a Flaskdata instance clearly showing 2 patients and 2 different sites with device failure issues.
Site coordinator experiences
Here is another example of how integrating the device logs with the PCM platform helps the site understand quickly why the patient is having treatment compliance issues.
The site coordinator, study monitor and study PM can now see the big picture for this patient – in this case, the patient has a device issue which impacts treatment compliance and reporting issues.
Treatment and patient reported outcome compliance
The data is then aggregated using a generalized patient compliance model to provide an overview and comparison of how the sites are performing on their patient compliance metrics. The site coordinator can drill down to individual patients as we saw above and run a playbook response to resolve the deviations. In a glance, we see that PRO compliance is very high at almost all the sites while the treatment compliance is at 71%.
People time is real-time
The word “democracy” (Greek: δημοκρατία) combines the elements dêmos (δῆμος, which means “people”) and krátos (κράτος, which means “force” or “power”), and thus means literally “people power”. With real-time PCM that is always accessible to all the members of the extended medical device clinical trial, we can achieve true democratization of data insights.