Mexico

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Women and clinical trials where have we been
and where are we going?by Catherine
HankinsChief Scientific Adviser to
UNAIDSGeneva, Switzerland
Hankins
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December Meeting Cosponsors



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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

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Meeting Agenda

• Historical evolution of womens 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

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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

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Making HIV trials work for women and adolescent
girls Action Plan
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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

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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

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http//www.cihr-irsc.gc.ca/e/32019.html
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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?

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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

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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)

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womenandtrials_at_unaids.org
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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!