EHRs needed for comparative effectiveness research, too

A year-old consortium of academic medical centers, pharmaceutical companies, and information technology firms is trying to find a way to harness electronic health records for clinical research. The Partnership to Advance Clinical Electronic Research (PACeR) is to be commended for its efforts, which could help researchers identify clinical trial subjects and improve protocol modeling and data collection.

As important as this undertaking is, however, there's another project that could have a far greater and more immediate impact on public health. In contrast to PACeR, this project is receiving no private funding, because it won't help any drug company make money. What I'm referring to is the use of EHRs in comparative effectiveness research (CER). What's most urgently needed now is to set up "pragmatic clinical trials" that compare the efficacy of different tests and treatments in typical practice situations, so that physicians will be likely to incorporate the results into their medical decisions.

The American Recovery and Reinvestment Act (ARRA) of 2009 allocates $1.1 billion to CER--including $300 million to the Agency for Healthcare Quality and Research (AHRQ), $400 million to the National Institutes of Health (NIH), and $400 million to the Secretary of Health and Human Services.

The Agency for Healthcare Research and Quality (AHRQ) has announced that it will devote its funds to disseminating current best practices to clinicians. A 2009 Institute of Medicine report recommended that the rest of the money be spent on review studies, retrospective observational studies using secondary data, patient registries, and pragmatic trials.

In essence, pragmatic trials are unblinded studies performed in typical practice settings without any special screening of study subjects. As outlined in a recent New England Journal of Medicine commentary on two pragmatic trials in the U.K., this approach has some pitfalls, including the possibility that some participants will switch therapies in midstream. But, the authors pointed out, these trials also have many strengths, and are more likely than academic clinical trials to sway physicians.

Carolyn Clancy, MD, director of AHRQ, has written that with the help of EHRs, "enrollment in prospective studies, including randomized controlled trials, could be expedited, as could data collection and management." That's where PACeR comes in.

But Clancy also told me in an interview a few years ago that the same approach could be taken in practice-based research networks, which do pragmatic trials. The challenge, just as in traditional clinical research, is that EHRs are not designed for this purpose, she said. But there's no reason why programs could not be written that would enable physicians to record in an EHR the observations required by a study protocol in the course of their daily work.

Will this happen? It will if the government allocates funds for that purpose. But I wouldn't expect private companies to do this unless it helps them develop new products that can generate profits for them. - Ken

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