Wednesday, June 30, 2010

Keeping Pace with Electronic Health Records to Improve Clinical Research

Cross-posted from Pfizer's Think Science Now

Electronic health records (EHRs) have gained a great deal of attention in the United States, with financial incentives under the American Recovery and Reinvestment Act and expectations for quality and cost factored into healthcare reform.

But what about the potential for electronic health records to impact clinical research? How may EHRs impact our ability to match patients for trials, select optimal investigator sites, or even test the feasibility of our study protocols?

Many have seen great opportunity to improve clinical research by accessing these emerging databases. But they have been challenged by large amounts of data coming from disconnected systems each with limited access. Concerns have also surrounded how to ensure privacy.

Now Pfizer has joined with other leading research centers, pharmaceutical companies, and health information technology organizations to announce the formation of the Partnership to Advance Clinical electronic Research (PACeR).

This is another in a growing list of examples of pharmaceutical companies working together to address common challenges – PACeR includes Pfizer along with Johnson & Johnson and Merck. They are also joined by Quintiles, a contract research organization.

PACeR is about health data improving research, and so the partnership includes the Healthcare Assocation of New York State (HANYS) along with a dozen leading New York hospitals and medical centers. To ensure patient benefit while maintaining patient protection (including privacy), the partnership includes the Hastings Center and the Legal Action Committee. Additional PACeR partners include FDA along with CDISC and HL-7, the former to provide regulatory guidance and the latter two focused on sharing data and interoperability.

One of my colleagues at Pfizer – David Leventhal (Director of Health Informatics) has been instrumental in executing this vision and assembling this consortium. From David:

“Clinical research is one of the most critical aspects of getting innovative medicines to patients. It has been extremely challenging to conduct high quality clinical research on a timely basis. We see the PACeR initiative as a unique collaborative opportunity to move beyond talking about the challenge, and to fundamentally change the way clinical research is conducted. This is an effort and outcome where everyone wins.”

PACeR is a great example of working across organizations and institutions to create sustainable new models to improve clinical trial efficiency.

Emphasizing the potential impact across clinical research, Leonard Sacks, MD (Acting Director for the FDA Office of Critical Path) commented:

“In tackling issues such as the role of electronic health records in clinical research, the potential to personalize medicine using bioinformatics, and the safeguarding of medical privacy, HANYS’ Partnership to Accelerate Clinical Electronic Research has embraced the task and we enthusiastically support their effort.”