Dipping a toe in the water is always easier than jumping right into something new.
I am reminded of this old axiom as I look back at the recent SCDM conference and see it holds true for eSource.
Testing different eSource modalities within a controlled environment is one way to get acclimated and explore the use of eSource in your clinical trials while building experience – all in a low-risk way. Beginning with data that's directly entered as eSource is a whole lot easier and safer than attempting to hit it 100 percent from the high dive on the first try.
If you're still reluctant to dip in a toe and swim from the shallow end of the pool with eSource, you're not alone as shown by the most-talked-about topics at the conference. Read on and you may find what you need to help overcome risks, whether perceived or real.
7 eSource Hurdles You Can Overcome
Sponsors face many hurdles to eSource implementation, fortunately most are readily overcome. Some of the more significant challenges discussed at the conference are summarized below. Recognize any holding you back?
- Sponsors want to be certain data is collected in such a way that does not trigger an FDA audit.
- Just as our industry generally moves at a slow pace in adopting new ways of doing things, so too are sponsors slow to change processes needed to implement eSource.
- SOP's and work instructions take time and effort to develop and to provide training on before they can be adopted.
- In organizations where paper is still being used to collect data a process change may be met with resistance.
- eSource reduces SDV, representing potential revenue loss for CROs. This may be cause for some to hold back on fully supporting its use at sites.
- Playing into the above, many sponsors have already budgeted for 100% SDV. So why do reduced monitoring, perceived by some to be risky?
- Confusion over who is in control of housing the EDC database. FDA eSource Guidance states "the clinical investigator(s) should retain control of the records," (Section IIIC, Guidance for Industry: Electronic Source Data in Clinical Investigations, Sept. 2013). Some sponsors are struggling with the meaning of 'retain control,' creating uncertainty as to whether their or the investigator's site is where the EDC database should be stored.
Sites' Likes and Dislikes with eSource
In examining eSource from the site perspective, off-line access was cited as one of the biggest issues. Site personnel want ease and speed. No surprise: they said page-turn times that take several seconds are just too slow.
Another thing site personnel say they dislike is a cumbersome EDC system navigation. Logging in and taking a circuitous route to find the right page with precious time wasted at each step along the way is not their idea of advancement. They complained some EDCs are more tedious to use than handwriting the information on paper!
On the flip side, site personnel voiced significant aspects of eSource preferred over paper:
- eSource removes transcription issues, eliminating those impossible-to-decipher scribbles on paper CRFs.
- eSource provides prompts to enter all required information. This is especially helpful in collecting information that falls outside what is normally collected. Site personnel explained that remembering to document sponsors' special requests can be easily overlooked using paper.
- eSource carries none of the burdensome physical storage requirements of paper source.
eSource and EMR Data
Discussion also explored challenges of using data from Electronic Medical Records (EMR). The point was made that clinical research is not the purpose of electronic medical records. As such, the EMR contains data not of the same clean quality required of clinical trials.
In further exploring obstacles of integrating with hospital EMRs, the significant coordination effort required with investigators and hospital IT departments was cited as a key issue. Also noted was the fairly extensive endeavor to map EMR data to an EDC system − despite having CDISC RFD already in place!
It was noted most hospitals now allow monitors to log in to their EMR, with some giving remote access to their systems, enabling remote monitoring capability. Considering all that's needed to use EMR data however, the steep obstacles seem to outweigh the benefits at this time as voiced by most conference attendees. The majority expressed it's simply not worth the hassle to use data from medical records as an electronic source.
Stay tuned for a final blog installment re-capping the conversation that happened this year at SCDM. I will also share some exciting news about what we are seeing with eSource here at BioClinica.