regard to sample size, meta-analysis of clinical data can be a valuable exercise before investment in a large clinical trial—it can help in designing trials strategically.

Other Groups

Although the focus of the workshop was on sex-specific analysis and reporting, some panelists pointed out that race and ethnicity may also be clinically relevant, as may other clinically, genetically, or socially defined characteristics. Berlin cited Freedman and colleagues (1995), who discussed the possibility of finding clinically unimportant but statistically significant differences or clinically important but statistically nonsignificant differences and argued against separate results in the absence of a priori evidence of subgroup differences. Berlin argued, however, that such clinical-trial results can point to basic science and the needs for further elucidation.

Clancy referred participants to a 2009 Kaiser Family Foundation report, Putting Women’s Health Care Disparities on the Map: Examining Racial and Ethnic Disparities at the State Level.3 The principles being discussed in the present workshop do not refer only to definitions of gender and sex but extend to other population groups as well, she stressed.

Managing the Data

Parekh highlighted several current FDA initiatives, including one focused on standardizing the data that are electronically submitted to FDA so that analysis of data on women and other populations is easier.

Clancy raised the concept of a learning health care system whereby medical knowledge is advanced by making use of the substantial amounts of data and other information collected every day in the provision of health care. The implementation of electronic health-record systems is a key component of a learning health care system. Many professional societies and other organizations have created patient-level registries, which offer another method of collecting data. Clancy added that AHRQ is using American Recovery and Reinvestment Act funds designated for comparative-effectiveness research and patient-centered outcomes research to develop “a registry of registries” that will be


3See (accessed August 26, 2011).

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