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Reinvestment Act will spur more research and produce more health data
Billions more going to research, medical centers
The American Recovery and Reinvestment Act, signed by President Barack Obama on Feb. 17, 2009, will provide both short-term and long-term benefits to the clinical trial industry.
In the short run, the act provides for billions of extra dollars to go toward research through grants from the National Institutes of Health (NIH) and the National Science Foundation.1
In the long run, it will lay the groundwork for a network of electronic health records (EHRs) from health system to health system nationwide.
The act specifically provides $1.5 billion to health centers for construction, renovation, equipment, and for the acquisition of health information technology systems. Billions of more federal dollars also are expected to help with implementing EHRs nationwide.
Researchers and experts who have studied best practices in implementing EHRs and new technologies say the potential clinical trial benefits from such a large federal undertaking are limitless. Electronic health records will provide an information access that will facilitate research in ways that are beyond what most investigators can envision, says Nir Menachemi, PhD, MPH, an associate professor in the department of health care organization and policy at the University of Alabama - Birmingham School of Public Health in Birmingham, AL.
For example, some observers have suggested that researchers with access to complete medical records electronically might not need to conduct clinical trials in some cases, Menachemi says. It might work like this: researchers would have unlimited clinical information longitudinally on patients in a large population. The information would detail outcomes for patients who received one type of treatment versus another type.
"You could unlock lots of relationships to subsequent outcomes and performance to interventions in ways that would rival clinical trials," Menachemi says. "So I think that would open new arms in the research world and perhaps in the regulatory world."
With such vast electronic data, the Food and Drug Administration (FDA) could have information about therapies almost in real time as a treatment is diffused out in the population, he adds.
Such data also would allow researchers to focus on individual populations, but on a much larger scale than they can now, Menachemi says.
"We'd be able to have access to this information that would at least give us a much better picture of expected outcomes, side effects, and that sort of thing," he adds.
Do it right or lose it
A researcher who has used comprehensive medical record databases in the United Kingdom says there is great potential for researchers, but only if the transition to EHRs is done properly with the potential for translation from one health care entity to the next.
"I strongly believe that given the research potential of this data that if we don't do it right in the beginning, we'll lose it," says Richard Tannen, MD, a professor of medicine at the University of Pennsylvania School of Medicine in Philadelphia, PA.
"There need to be serious discussions right off the bat about how to do this and how to do it right," Tannen adds. "And the only way that will happen is for the federal government to empower the kinds of groups that could really address this issue and develop standards for what needs to be done and how it needs to be done."
If national standards are not developed, then there would be a hodgepodge of medical records, and the research advantages will be lost, Tannen says.
Even comprehensive databases like the United Kingdom's have weaknesses that could be avoided with a federal effort here, he notes.
"Ideally, we could do better than the UK database," Tannen says. "One weakness in the UK database is that the data from the late 1980s to 2000 wasn't linked to lab database, so any studies that required useful lab data couldn't be done."
The older UK database also is missing information on blood pressure, weight, and smoking history, he adds.
One of the major challenges for transforming and linking the nation's health systems through EHRs involves the security requirements necessary to keep the data safe and confidential.
Experts who have dealt with privacy and confidentiality issues in electronic research data say this challenge of national electronic integration cannot be underestimated.
"It's not going to be easy to get there," says Philip A. Cola, MA, vice president of research and technology at the University Hospitals Case Medical Center in Cleveland, OH. "In our own family of health care sites, we had to carry medical records from this facility to that one instead of having a physician being able to look it up on his computer. We've had to figure out ways not only within our health system, but between health systems in Ohio for sites to communicate with each other."
The University Hospitals Case Medical Center is one of 38 Clinical Translational Science Award (CTSA) centers across the country.
"One of the goals is from an informatics standpoint to get institutions to communicate with each other through EHRs and through electronic datasets for research," Cola says. "So UH will have to build a bridge locally with other hospitals in town and other academic medical centers across the country."
Such infrastructure work will take time and careful consideration about protections for privacy and confidentiality, he adds.
"What we're doing within our health system in principal would work on a larger scale," Cola says. Researchers who've conducted pilot studies testing a new treatment among their own patient population could have access to a large database of potential trial participants from across the country, he adds.
"If you're someone in Pennsylvania, and you have a type of condition, and doctors don't know what is the next best option for your treatment, then you'd be excited to receive a phone call from an investigator in Cleveland who says, 'I have a protocol that could benefit you,'" Cola says. "This is a good thing and I'm excited about it."