Health Affairs: HHS needs to overhaul comparative-effectiveness approach
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In the article, Lynn M. Etheredge, PhD, who heads the Rapid Learning Project at the George Washington University in Washington, D.C., suggested new policies and investments should exploit the rapid-learning potential of EHRs, computerized databases, data sharing and research networks.
“The key to this rapid-learning strategy is research that would apply the power of high-speed computers to a new national system of clinical research databases. This strategy requires new databases predesigned and pre-populated to fill in key evidence gaps for effectiveness studies—for example, by drawing on the EHRs of millions of patients,” Etheredge wrote.
He suggested four proposals for building national comparative-effectiveness research capabilities:
- A new technologies learning system;
- Comparability standards for comparative-effectiveness research;
- A presidential order establishing a National Database for Effectiveness Research Studies; and
- A national clinical research system supported by EHRs.
“At the point of market approval or the start of Medicare payments—in the case of surgical procedures—HHS, in consultation with the private sector, would establish a national research plan for the technology or class of technology in question. The plan would specify metrics for comparing effectiveness; propose key questions about appropriate uses, effectiveness and safety; create national reporting registries; and assign funding responsibility for studies."
At the end of an initial period—for example, three years—expert panels would review the evidence and determine future research needs. Medicare, Medicaid and private-sector payers would adopt common "coverage with evidence development" policies to require reporting of needed data from healthcare providers to answer key research questions as a condition for payment. To design and implement this comparative-effectiveness research study system, the federal government should work with physicians, patients, researchers, the new Patient-Centered Outcomes Research Institute, health insurance plans, as well as pharmaceutical and biotechnology companies.
The federal government should set research priorities such as new cancer treatments, new surgical procedures and off-label uses of drugs, according to Etheredge.
In addition, “if the federal government and its collaborators can create comparability among clinical studies, many questions about comparative effectiveness could be resolved by quick, easy comparisons of data sets. At the very least, investigators would find it easier to understand what is known and what is not known and then proceed to fill research gaps,” he wrote.
Etheridge recommeded the creation of a National Database for Effectiveness Research Studies—an evidence base for clinical science and comparative-effectiveness studies. "Its foundation is already in place at clinicaltrials.gov, which contains basic information about many of these studies. The federal government should require that all publicly funded studies of clinical effectiveness upload standardized data to this database, where deidentified data would be freely available for worldwide use," he said.
“This database could also be augmented from the new rapid-learning cycle by observational research, data from registries and information from the new-technologies study initiative. It would link the FDA’s databases, which, when finally computerized, will include the world’s most comprehensive drug safety and effectiveness data," he wrote.
“The HHS secretary could establish new data policies and a national effectiveness database on her own authority. However, data-sharing policies have been sensitive and controversial issues. In fact, the NIH was ineffective in gaining voluntary compliance with a policy that asked its grantees to provide published studies stemming from their research to an open-access federal website," he wrote.
“An executive order from the president would be the most reliable way to create a new National Database for Effectiveness Research Studies," Etheredge wrote. "Federal policy should aim, as soon as possible, to ensure that national registries and linked databases have enough high-quality data to answer the most important comparative-effectiveness research questions. Some measures are already in motion. A number of investments will be supported by the $1 billion comparative-effectiveness research funding from the federal stimulus legislation.
“HHS needs work plans to undertake key steps. These include assigning public accountability within the agency to answer the priority comparative-effectiveness research questions of physicians and patients; providing financing for research initiatives; and creating a timetable that specifies the date by which the agency will know the answers to these questions,” he said.
“For the longer term, we need a health system that will learn about the best use of new technologies as quickly as it produces new technologies,” Etheredge concluded. “To be a successful leader in creating a rapid-learning health system, HHS will need to support comparative-effectiveness researchers to make full use of all of the evidence that can be made available."