Sex-Specific Reporting of Scientific Research A Workshop Summary (2012) / Chapter Skim
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WHY SEX-SPECIFIC REPORTING IS IMPORTANT
WHY SEX-SPECIFIC REPORTING IS IMPORTANT
Pages 5-10
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From page 5... ...
, reminded participants that the severe birth defects associated with thalidomide use by pregnant women in the 1960s led to a conservative approach to testing of new drugs in women. In 1977, FDA issued General Considerations for the Clinical Evaluation of Drugs, which stated that "women of childbearing potential should be excluded from the earliest dose-ranging studies." Although the guidance went on to state that such women could be included in further studies if additional evidence had been amassed on the safety or preclinical toxicity of a drug, that exclusion inadvertently led to the underrepresentation or exclusion of women from all clinical trials.
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From page 6... ...
Jesse Berlin, vice president of epidemiology at Johnson & Johnson Pharmaceutical Research and Development, said that sex-specific reporting helps to define the most appropriate population for treatment and to determine whether benefits or harms differ by sex. Differences between the sexes are more than just pharmacokinetic, however.
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From page 7... ...
application and new drug application (NDA) regulation, also called the demographic rule, requires NDA submissions to provide safety and effectiveness data and IND submissions to tabulate numbers of participants according to age,
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From page 8... ...
Parekh noted that data reported in poster sessions at a recent Drug Information Association meeting indicated that analysis of safety and efficacy data by sex has been increasing -- around 75% of clinical trials in 2007–2009 reported analysis by sex -- and a review of approved product labels found that nearly all included pharmacokinetic information by sex. With regard to reporting in the literature, Nolan said that a decade ago the NIH ORWH, in collaboration with SWHR, convened a meeting of scientific-journal editors to discuss the development of specific instructions for authors and reviewers about the analysis of clinical-trial data by sex.
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From page 9... ...
Great strides have been made in raising public awareness about sex-based differences in cardiovascular, muscular, skeletal, and behavioral health and disease, but only rarely are medical-care options tailored to the patient's sex, Nolan said. She suggested that it could take less time for research to be translated into medical practice if major journal publishers required analysis by sex and reporting of differences found or the lack thereof.
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From page 10... ...
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.
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