Sex-specific Reporting of Scientific Research: A Workshop. Dr. Nancy Adler Planning Committee Chair Introductory Remarks

Transcription

1 Sex-specific Reporting of Scientific Research: A Workshop Dr. Nancy Adler Planning Committee Chair Introductory Remarks

2 Dr. Bernadine Healy 2

3 Dr. Vivian Pinn 3

4 Planning Committee Members Nancy E. Adler,, Ph.D. (Chair) Professor of Medical Psychology Director, Center for Health and Community University of California, San Francisco Marietta Anthony, Ph.D. Director of Women s Health Programs Critical Path Institute Floyd Bloom, M.D. Professor Emeritus Molecular and Integrative Neuroscience Department The Scripps Research Institute Jerome P. Kassirer, M.D. Distinguished Professor, Tufts University School of Medicine Visiting Professor, Department of Medicine, Stanford University Jon Levine, Ph.D. Professor, Department of Neuroscience Director, National Primate Research Center University of Wisconsin-Madison Harold C. Sox, M.D., M.A.C.P. Professor of Medicine Emeritus, Dartmouth Institute for Health Policy and Clinical Practice Dartmouth Medical School 4

5 Findings of Women s Health Research: Progress, Pitfalls, and Promise Lack of taking account of sex and gender differences in the design and analysis of studies, and lack of reporting on sex and gender differences has hindered identification of potentially important sex differences and slowed progress in women s health research Despite improved inclusion of women in trials funded by NIH and reviewed by FDA, there has been a lag in the routine analysis and reporting of data by sex (GAO, 2000, 2001). Including adequate numbers of women in clinical trials is necessary but not sufficient to ensure that results are applicable to women. 5

6 Recommendation of Women s Health Research: Progress, Pitfalls, and Promise The International Committee of Medical Journal Editors and other editors of relevant journals should adopt a guideline that all papers reporting the outcomes of clinical trials report on men and women separately unless a trial is of a sex-specific condition (such as endometrial or prostatic cancer). The National Institutes of Health should sponsor a meeting to facilitate establishment of the guidelines. In response, the Office of Women s Health Research of the National Institutes of Health sponsored this workshop 6

7 This is not specifically a women s health issue. Sex-specific reporting would benefit women and men, and provide a better understanding of research results for everyone 7

8 Workshop Statement of Task An IOM committee will plan and conduct a one day scientific workshop to explore the benefits of and barriers to sex-specific reporting of scientific data. Topics should include: 1) Need for sex-specific reporting of scientific result 2) Potential barriers and unintended consequences 3) Experiences of journals that have implemented sexspecific requirements 4) Steps to facilitate the reporting of sex-specific results 8

9 Clinical Trials Women comprised only 38.8% of participants in non-sex-specific prospective clinical studies (Jagsi, 2009) 9

10 Example of Cardiovascular Disease Predominance of men in cardiovascular trials (Sharpe, 2002) 19 randomized controlled trials only 27% of participants were female; only 13 presented sex-based analyses (Kim and Menon, 2009) AHRQ study found that studies of coronary heart disease rarely included women or women in adequate numbers for analysis of the data by sex (Grady et al., 2003). 10

11 Example of Cardiovascular Disease: Unintentional Bias in Design Inclusion Criteria Early age of onset of myocardial infarction and chest pain as a presenting symptom will favor enrollment of men over women (Bairey Merz et al., 2006; Canto et al., 2007) 11

12 Example of Cardiovascular Disease: Unintentional Bias in Design End Points Unstable angina, unrecognized myocardial infarction, and stroke are more common in women In studies of cardiovascular disease, clinical-trial subjects have not been representative of the general population (Lloyd-Jones et al., 2001; Pedone and Lapane, 2003) 12

13 Example of HIV Of the women eligible to participate in the Women s Interagency HIV Study, about half would have been ineligible, on the basis of exclusion criteria, to participate in 20 of the AIDS Clinical Trials Group studies, which are among the largest HIV clinical-trial groups in the United States (Gandhi et al., 2005) 13

14 Animal Models Male bias in 8 of 10 biological fields. Greatest bias in neuroscience: male animals outnumber females 5.5 to 1 (Beery and Zucker, 2009) 14

15 Workshop Agenda Opening Remarks Why Sex-Specific Reporting is Important Sex-specific Reporting Policies: Implications for Researchers Experiences of Journal Editors Implementing Editorial Policies Sex-specific Reporting Policies: Implications for Journals Reflections and Looking Forward 15