Substantial unmet needs exist in the diagnosis and treatment of gynecologic cancers. Often, these tumors are detected in later stages when treatment options are limited, and prognosis is poor. However, the gynecologic cancer space is on the cusp of change. The recent introduction of novel medicines, namely targeted therapies, has improved patient care and outcome….
Expertise: Women's Health 21 results
The Role of Maintenance Therapy in Gynecologic Cancer Treatment
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…
Heavy menstrual bleeding (HMB) is one of the most common gynecologic disorders among women of reproductive age, accounting for up to one-third of all gynecologic office visits.1 HMB refers to bleeding associated with regular ovulatory cycles and involves blood loss greater than 80 ml per month. It is a subcategory of abnormal uterine bleeding (AUB),…
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,…
Designing Trials for Patients
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…
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…
Women-Centric Approach to Clinical Trials
For decades, women were left out of clinical trials, despite the fact that they often process drugs differently than men due to their size, biology, and physiology.