Integrating Clinical Trial Data to Bring Products to Market Faster
All clinical trial data is digital. We have to submit it to the FDA in a digital manner but it currently gets there in a disparate manner with many systems involved. What is needed to bring products to market faster is what is now known as a "clinical ecosystem." This was something I wrote about before this great term was coined. The concept is that new product development can take place faster through the ongoing integration of electronic data within a clinical ecosystem.
My original degree was in Physiology and Zoology, so I am familiar with the ecology of natural ecosystems. Within any ecosystem there are a series of micro ecosystems. Each ecosystem can be viewed separately but operates collectively within a larger system. So when we talk about clinical trials the macro ecosystem is the clinical drug development program. Each trial is an ecosystem and within this there are micro ecosystems of clinical trial data, e.g. medical imaging, ECG, patient diaries etc.
A paper case report form has to be converted to electronic format for entry into the clinical trial database, an X-ray or DXA image has to be quantified and measured with the result being electronic data. The clinical trials process ends up being about the capture, analysis and reporting of this electronic data. The process of getting this data into a single data base is currently created by numerous databases working independently. The oversight of all of this information is almost impossible to achieve at the single trial level, let alone the clinical program.
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If we considered the whole process to be an electronic pipe where all the patient data feeds in, then all the connected items and clinical trial monitoring systems could then provide real time monitoring. The range of data inputs into the clinical ecosystem is unlimited and extends from the shipment of clinical trial supplies being linked to the IVR system; to the investigator payments being linked to electronic CRF completion; to the CRA's being able to monitor in real-time how their investigators are completing their CRF's; to the patient diaries being linked directly into the same information platform. |
Imagine a cardiovascular clinical trial where a patient uses mobile cardiac telemetry to provide real-time heart-rate data to a call center that analyzes the ECG and delivers the results to the patient's electronic health record (EHR). The EHR then automatically feeds data into the case report form (CRF) that is then monitored and reviewed remotely by a virtual Clinical Research Associate (CRA).
I look forward in future posts to sharing my thoughts on new developments and innovation in medical imaging, biomarkers and how this technology can be used to best effect in clinical trials.