Women-Centred Clinical Trials Facilitation

Though physiologically different, women and men are typically prescribed the same drugs to fight their illnesses. Historically, women were often excluded from research participation. Although impressive advances in policies have been made to promote participation of women in research studies, gaps in knowledge remain regarding the behaviour of drugs in women and women-specific health issues.

In order to reduce these gaps and increase the base of biomedical knowledge about specific conditions and diseases, sufficient numbers of women from a diversity of ethnic backgrounds and age groups, and with a variety of health profiles, are needed to participate in clinical trials.

To address the knowledge gaps surrounding women-centered clinical studies, the WHRI offers an experienced team to provide trial implementation and facilitation services. The WHRI Clinical Trials Unit includes a diverse, multidisciplinary team including certified clinical research coordinators, research nurses, and project management professionals. The WHRI Clinical Trials Unit has a history of success in influential trials including extensive experience in sexual health, perinatal research and maternal vaccination studies.

Our team is equipped with experience and expertise in the following areas:

  • Clinical trial set-up and Health Canada approval
  • Compiling regulatory documentation
  • Ethics applications
  • FDA trials
  • Transportation of Dangerous Goods certification
  • Sample shipment
  • Standard Operating Procedure (SOP) development
  • Audit & audit preparation
  • Quality assurance
  • Budget development
  • Project management
  • Case report form (CRF) development
  • Electronic CRFs
  • Severe Adverse Event (SAE) tracking and reporting
  • Good Clinical Practice (GCP) training
  • Physical assessment
  • Gender-specific recruitment techniques
  • Retention strategies

Request for assistance from the WHRI Clinical Trials Unit:

If you would like to request the assistance of the Clinical Trials Unit, please contact the WHRI Senior Research Manager, Dr. Kathryn Dewar, by email (kdewar@cw.bc.ca) or phone (604-875-2424 ext. 4909)

Links to additional resources:

Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences (Health Canada)
 Website: The Inclusion of Women in Clinical Trials (U.S. FDA)
 Website: Inclusion of Women and Minorities in Clinical Research (NIH Office of Research on Women’s Health)