PO Job Aid – Addressing Sex and Gender in Clinical Trials
The research was conducted in response to a question of how gender is used in clinical trials. The resulting Job Aid is intended to support Bill & Melinda Gates Foundation program officers in helping grantees to implement gender-intentional trials as part of the foundation’s commitment to addressing gender equality across its work.
Case Study in Gender Integration – Sex Differences in the Effects of Pharmaceutical Products
This case study explores the FDA’s post-approval decision to introduce sex-specific dosing of Zolpidem (Ambien). This is a public example of the possibility of sex differences in drug efficacy and raised questions as to whether the drug development industry has adequately explored sex differences in clinical trials.
Case Study in Gender Integration – Taking on Gender in Clinical Research
The International AIDS Vaccine Initiative’s (IAVI’s) focus on gender is unique among product development partnerships and demonstrates the value of using a gender-intentional approach in clinical research. This case study explores IAVI’s efforts, starting in the early 2000s, to engage women in trial communities and ensure gender-sensitive trial practices.
Case Study in Gender Integration – Contraception and Gender in Microbicide Trials
Early vaginal microbicide trials were challenged by poor contraceptive use among participants and high rates of incident pregnancy. This case study looks into the reasons for this, and their possible root in the same gender norms and barriers that affect women’s use of contraception outside of the clinical trial context.