Advanced ovarian and endometrial carcinomas present the greatest challenge in treating gynecologic cancer and, among the five types of female cancers, are responsible for the most U.S. deaths annually.1 With a combination of surgery, chemotherapy, and radiation; patients can go into remission, but the majority will have a recurrence after several months or years. There...
Gynecologic cancers are comprised of five major types: ovarian, uterine, cervical, vaginal, and vulvar. All women are at risk for these, and risk increases with age. Specific risk factors include a family history, human papillomavirus (HPV) infections (cervical cancer), genetic mutations such as BRCA1 and BRCA2 (ovarian cancer or OC), and hormone replacement therapy. Early...
Our focus on women’s health research means we’re sensitive to the concerns and needs of the female volunteers contemplating clinical trial participation. In order to effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every step of the clinical research process. Regularly engaging women, their physicians, and health advocates helps...
According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the substantial amendments are implemented during the study enrollment period, mainly due to difficulties in recruiting...
Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening to patients living with a condition, we can proactively address potential flaws in clinical...
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,...