A balancing act Given all that is happening in this arena, why wouldn't we want to capitalize on whatever we can to improve clinical research?
When you look at the capabilities of a health information exchange package that can bring together the medical records of
many different patients from many different care locations using many different systems—how difficult can it be to make CRF
data from one sponsor look more like that from others? Maybe the way we conduct our research data doesn't really have to be so different from the way data are collected at health
care organizations, so we can really leverage the full potential promise of HL7 standards eventually. Maybe some day, anyway. But it comes down to maintaining a balance of what should be done with what can be done and, most importantly, what must be
done. We do what we must, chip away at what we can, and eventually hope to see some light peeking out from the end of the tunnel
to where we should be going. This will continue to happen, and if the rate of adoption of EHR systems used to collect clinical
research data manages to occur at, say, even twice the pace at which EDC was adopted, we may see penetration reach as much
as 50% in another 10 years. In the meantime, there's likely to be a lot of life still left in those old EDC systems, conducting the bulk of our current
clinical trials and slowly converging with the health care world as it becomes increasingly ready and willing. So don't give
up the day job just yet. Wayne R. Kubick is Senior Vice President and Chief Quality Officer at Lincoln Technologies, Inc., a Phase Forward company based in Waltham,
MA. He can be reached at wayne.kubick@phaseforward.com
References HIMSS Publishes Its Definitions of 'Meaningful Use,' http://www.himss.org/ASP/ContentRedirector.asp?ContentID=69148&type=HIMSSNewsItem/, (April 2009). "Pfizer Project Looks at Side Effects," Wall Street Journal (January 2009), http://online.wsj.com/article_email/SB123085142405347511-lMyQjAxMDI5MzAwMjgwNTIxWj.html.
A.K. Jha et al., "Use of Electronic Health Records in U.S. Hospitals," http://content.nejm.org/cgi/reprint/360/16/1628.pdf.
"Is EHR Vendor Consolidation Ahead?" Health Data Management (April 2009), http://www.healthdatamanagement.com/news/EHR-28022-1.html?ET=healthdatamanagement:e829:23435a:&st=email&channel=electronic_health_records/.
| 
