New report recommends standard definitions and data collection methods for asthma clinical studies

Office of the Director - March 5, 2012

A consortium of federal agencies and non-governmental organizations has published a report recommending a set of standard definitions and data collection methods to be used in asthma clinical studies across seven key outcomes, including symptoms, exacerbations such as asthma attacks, biomarkers, and quality of life. The report was published as a supplement to the Journal of Allergy and Clinical Immunology on March 2 and released at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting in Orlando on March 3.

The NHLBI and other NIH institutes have long supported research to understand the causes of asthma and develop new ways to treat and prevent it. One challenge facing the asthma research community, however, has been a lack of standard definitions and data collection methods across studies. To develop such standards, in 2010 several NIH institutes—including the NHLBI—and partners convened a multidisciplinary team of allergists, pulmonologists, experts in pediatric and adult medicine, behavioral scientists, statisticians, clinical trialists, and those with expertise in disparities research for a workshop.

"We were tremendously impressed by the enthusiasm and experience all the workshop participants brought to this project," said James Kiley, Ph.D., director of the NHLBI Division of Lung Diseases. "We obviously tapped into a need among the scientific and asthma care communities."

The result, he said, is a set of "scientifically solid and credible recommendations" that the team hopes will be adopted by all asthma clinical trial investigators. Following a consistent set of definitions and outcome measures would allow researchers to interpret study findings more carefully, compare the results of different studies, and pool data for genetic studies, aiding in the development of new treatment and prevention strategies and ultimately improving asthma care.

Next, said Kiley, "we will engage our federal partners and put this report into action." The NIH and other federal agencies will consider the recommendations and require that future NIH-funded asthma clinical research studies include the recommended outcomes.

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