eSource: Not New But Not in Full Force?

eSource is not a new term. But eSource does seem to be getting a lot of attention lately. We have an eSource questionnaire, open right now for your input and CBI, our sister conference division, will feature eSource Data in Clinical Investigations May 4-5 in Philadelphia.

Is eSource the “new” EDC? In 2004, if you do a reality check, was 10 years ago. At that point, in Applied Clinical Trials we published an article that states: “Recent analyst research has identified that at best only 30% of ongoing clinical trials are conducted using EDC.” And while we have given up reporting on the lack of EDC uptake, paper is still in use in many trials-particularly smaller and/or Phase I trials.

eSource could be gaining attention as an outgrowth of the acceptance of risk-based monitoring. Both RBM and eSource Guidances were released by FDA back-to-back in August and September of 2013 respectively. FDA’s Guidance for Industry Electronic Source Data in Clinical Investigations specifically says “This guidance addresses source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol.” It says that data can be entered into the eCRF manually or electronically, in the following ways:

·      Direct entry of data into the eCRF

·      Automatic transmission of data from devices or instruments directly to the eCRF

·      Transcription of data from paper or electronic sources to the eCRF

·      Direct transmission of data from the electronic health record to the eCRF

·      Transmission of data from Patient-Reported Outcome (PRO) instruments to the eCRF

So this Guidance connects to RBM in the ways in which companies gather data in real-time to monitor sites more efficiently.

But eSource has been recognized also back in the dark ages of 2004 when a CenterWatch and CDISC survey found sites ranked “electronic source documentation online” first in a list of ways to better leverage technology.

Last week, Clinical Ink announced its merger with CentrosHealth, a provider of configurable mobile apps for clinical trial patient engagement and ePRO. ClinicalInk’s SureSource Wiindows-based tablet and stylus product was the first purpose-built product to capture source documents/data during the subject visit, and was released in 2007. It is a truly enabled “eSource” solution.

Is eSource next gen EDC, the real eClinical or a slice of tech life at the site? We look forward to gathering your input and also hope to see you at the conference where more questions will be answered.