Although impressive advanced in policies have been made to promote the participation of women as subjects in researh and analysis of data, gaps in knowledge remain regarding the behaviour of drugs in women. In order to remove 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 underlying conditions, are needed to participate in clinical trials.
A major ethical consideration is the inclusion of women of childbearing age in clinical trials. Although pregnant women have largely been excluded from clinical trials studies in the past, they do use drugs during pregnancy, and could be done safely by using small, well-designed trials with enhanced safety monitoring, and would ultimately result in reliable, evidence-based data to ensure safe treatment options.
It is also essential to conduct studies that include and describe the different phases of a woman's life, and to classify women by the reproductive stage, instead of by age only. Research designs and study instruments should be developed that describe the menstrual cycle longitudinally and assess hormonal differences across menstrual cycles.
To address the knowledge gaps surrounding women-centered clinical studies, the WHRI is developing enhanced capacity to fill this void.
Our increasing capacity will enable us to provide more and better service to our clients, provide greater safety for our clinical trial subjects, and also make them more comfortable when they participate in these important clinical research efforts.
Our team is equipped with experience and expertise in the following areas:
- Experience with Electronic CRFs
- Compiling regulatory documentation
- FDA trials
- Transportation of Dangerous Goods certification
- SOP development
- Audit
- Quality Assurance
- Budget development
- Project management
- Case report form development
- SAE tracking and reporting
- GCP training
- Physical assessment
- Gender-specific recruitment techniques
