Hankins

1. ‘Women and clinical trials: where have we been and where are we going?by Catherine HankinsChief Scientific Adviser to UNAIDSGeneva, Switzerland Hankins Women and clinical trials: Where have we been and where are we going?

2. December Meeting Cosponsors Women and clinical trials: Where have we been and where are we going?

3. Definitions • Sex: • biological differences between males and females. • typically considered to be a binary category • Gender: • a socially-constructed notion of what is feminine and what is masculine • socially defined differences between men and women • Gender is a continuous category: a person can be more or less feminine or masculine Women and clinical trials: Where have we been and where are we going?

4. Meeting Agenda • Historical evolution of women’s participation in clinical trials • State of knowledge on sex differences in biomarkers, pharmacokinetics, and drug interactions • Interaction between reproductive health and HIV • Gender issues in new prevention technologies and treatment paradigms • Barriers, challenges and opportunities for research for women and adolescent girls • Outcomes: • Policy and programmatic recommendations • Research agenda • Advocacy plan Women and clinical trials: Where have we been and where are we going?

5. Recommendations • Establish a “new norm” that it is not acceptable for research on critical health and drug interventions to exclude women, or to include them in token numbers. • Build mechanisms of accountability within regulatory frameworks and other standard setting bodies to require trials to gather, analyze, and report sex disaggregated data. • Ensure that women are adequately represented in all HIV-related trials that may affect them – basic science, prevention, treatment, structural – and that they are enrolled and retained in sufficient numbers to allow for adequate power to draw conclusions based on subgroup analyses Women and clinical trials: Where have we been and where are we going?

6. Making HIV trials work for women and adolescent girls: Action Plan Women and clinical trials: Where have we been and where are we going?

7. Working Mechanisms • Steering Committee: UNAIDS, Global Coalition on Women and AIDS, International Centre for Research on Women, and Tibotec • Current Working Groups: • Score card • Sexual and reproductive health • ‘Biomedical editors’ • Good clinical practice • Secretariat: Staff in the Office of the Chief Scientific Adviser at UNAIDS Women and clinical trials: Where have we been and where are we going?

8. Biomedical editors working group • Assessed public research sponsors funding requirements for research proposals (NIH, CIHR, MRC, ANRS, etc.) • Contacted Consort Group to see if the checklist for reporting on clinical trials could be modified to add a sex- and gender-related components • Proposed the addition of questions to the International Medical Journal Editors annual meeting Women and clinical trials: Where have we been and where are we going?

9. http://www.cihr-irsc.gc.ca/e/32019.html Women and clinical trials: Where have we been and where are we going?

10. Women and clinical trials: Where have we been and where are we going?

11. Sex/Gender In Clinical Trial Manuscript Submissions(presented by Richard Horton to the International Medical Journal Editors annual meeting June 2008) Five key questions to assist medical journal editors and/or peer reviewers in assessing manuscripts that report on clinical trial outcomes. • Where the health priority studied affects both men and women, have both women and men subjects been included in the trial and if so, have they been included in sufficient numbers so as to be able to assess outcomes in each and differences between them? • Have women subjects been excluded and, if so, for what reasons (i.e. cost, reproductive considerations, etc.)? • Have the data been disaggregated by sex and analyzed by sex and gender? • Were anatomical and physiological differences between men and women (i.e. height, weight, body fat-to-muscle ratios, cell counts, hormonal cycles, etc.) as well other variables (socio-economic, education, access to care, etc.) taken into consideration in the presentation of data and/or analysis of the results? • If a statistically significant difference was found between men and women in the effects of the studied intervention, are the implications, if any, for clinical and/or public health discussed? Women and clinical trials: Where have we been and where are we going?

12. Good Clinical Practice Working Group • Reviewed the International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines for content on women, adolescent girls, and community engagement, finding no mention of sex or gender • Requested consideration for endorsement of the UNAIDS/AVAC Good participatory practice (GPP) guidelines • Exploring the possibility of harmonisation based on the 1993 NIH policy, enacted by public law, explicitly stating that women must be included in any clinical studies conducted or supported by NIH Women and clinical trials: Where have we been and where are we going?

13. Women and clinical trials: Where have we been and where are we going?

14. Guidance on conduct of HIV biomedical HIV prevention trials • UNAIDS has produced two products to guide scientifically rigorous and strong ethical conduct of both ongoing and future biomedical HIV prevention trials, both of which address women and adolescent girls • Good Participatory Practice Guidelines (with AVAC) and Ethical Considerations (with WHO) Women and clinical trials: Where have we been and where are we going?

15. Women and clinical trials: Where have we been and where are we going?

16. Women and clinical trials: Where have we been and where are we going?

17. Women and clinical trials: Where have we been and where are we going?

18. womenandtrials@unaids.org Women and clinical trials: Where have we been and where are we going?

19. Thanks to: • Tania Lemay, Elizabeth McGrory, Nicolai Lohse • Participants in the consultation, Steering Group and Working Group members • Women in HIV prevention and therapeutic trials everywhere • Far-sighted medical editors, regulatory bodies, and research agencies setting standards • All who are participating in creating new norms on women and clinical trials, including you! Women and clinical trials: Where have we been and where are we going?