© 2000 by Oxford University Press
Journal of the National Cancer Institute, Vol. 92, No. 19, 1561,
October 4, 2000
© 2000 Oxford University Press
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Journal to Encourage Analysis by Sex/Ethnicity
In accord with recently revised National Institutes of Health guidelines on the inclusion of women and minorities in clinical research, the Journal of the National Cancer Institute is asking authors to perform subgroup analyses by sex and ethnicity in clinical and epidemiological studies when appropriate.
The new Journal policy appears in this issue in the Information for Authors (p. 1621). It states, "Where appropriate, clinical and epidemiological studies should be analyzed to see if there is an effect of sex or any of the major ethnic groups. If there is no effect, it should be so stated in Results."
"The policy reflects the Journal’s commitment to sound, scientific research and to the possibility that different cancers and treatments can affect subgroups differently," said Barnett Kramer, M.D., editor in chief of this Journal and director of the NIH Office of Medical Applications of Research.
The original NIH guidelines, which were the subject of a May U.S. General Accounting Office status report, were published in the Federal Register in March 1994. The guidelines mandate that women and members of minority groups must be included in all NIH-supported biomedical and behavioral research involving human subjects. Exceptions to the guideline include studies on sex-specific diseases or studies that may compromise the health of a specific subgroup. The guidelines also emphasize that women and minorities and their subpopulations must be included in phase III trials so valid analyses of differences in intervention effect can be performed.
The GAO report stated that NIH has "made significant progress in implementing a strengthened policy on including women in clinical research." According to NIH’s Office of Research on Women’s Health, 61.9% of participants in all 1997 NIH-funded extramural research protocols were women, and 67.0% of participants in all 1998 protocols were women.
However, the report also noted that although there is strong evidence that "NIH staff and reviewers routinely focus on studies’ general inclusion of women, evidence as to whether they were taking care to implement the requirement related to analysis by sex was scant."
In response, NIH revised the guidelines in August to clarify requirements for phase III trials (the update is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm). For diseases in which prior studies support the existence of differences among subgroups, NIH will now require that subset analyses be reported to NIH in progress reports, competitive renewal applications, and in the final progress report.
In addition, the revised guidelines state: "Inclusion of the results of subset analyses is strongly encouraged in all publication submissions. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice."
Although the revised NIH guidelines apply specifically to phase III trials, the Journal will encourage sex- and ethnic group-specific analyses in other study designs when such analyses can yield a meaningful result, Kramer said. (For some examples of gender differences in cancer, see related story, (p. 1560).
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