Addressing Research For Women From Every Angle

When sponsors develop drugs and devices specifically for women, they need to create trials that are uniquely female-focused. From protocols and endpoints, to recruiting strategies and messaging, these trials have to take into account the unique needs, expectations and regulatory requirements of a totally female population.

Having spent more than 20 years in this space, I’ve learned a lot about the adaptations sponsors and CROs can make to better meet the needs of regulators, sites, and the women they want to recruit. Many of these changes are subtle, but can have a big impact on trial outcomes.